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Efficacy of Parent-Child Interaction Therapy With Autism Spectrum Disorder (PCIT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02088905
Recruitment Status : Completed
First Posted : March 17, 2014
Results First Posted : March 1, 2019
Last Update Posted : March 22, 2019
Sponsor:
Collaborator:
Autism Speaks
Information provided by (Responsible Party):
Benjamin L Handen, PhD, BCBA-D, University of Pittsburgh

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Noncompliance
Intervention Behavioral: Parent Child Interaction Therapy
Enrollment 25
Recruitment Details

Recruitment began June 2014, with clinicians at the Merck Center for Autism and Developmental Disorders or from the Child Development Unit bringing up the study to patients.

140 subjects were excluded during phone screen. 77 did not meet inclusion criteria, 39 declined consent due to high burden of time/procedures, 24 refused for other reasons.

Pre-assignment Details Two subjects of the originally enrolled 25 were discovered to have not met inclusion criteria. Upon the discovery, they were removed from the study and not randomized to any study condition.
Arm/Group Title Parent Child Interaction Therapy Wait List Control
Hide Arm/Group Description

Families will either receive Parent Child Interaction Therapy or be placed on a wait-list control group

Parent Child Interaction Therapy: Parent-Child Interaction Therapy (PCIT) is a research-supported parent coaching intervention that has been found to be highly effective among typically developing preschoolers presenting with a range of mental health concerns, especially defiance and noncompliance.6 PCIT holds considerable promise as a potentially effective treatment for children with ASD because it directly addresses the behaviors parents of children with ASD report to be most problematic for them - defiance, stubbornness, and temper tantrums. PCIT is theoretically consistent with other approaches that have shown promise in treating ASD (i.e., behaviorally-based); however, PCIT is unique in that it incorporates a socially-based initial phase which may have some unique benefits for children with ASD.

Families will wait 18 weeks for treatment, serving as controls.
Period Title: Overall Study
Started 13 10
Week 9 [1] 10 9
Completed [1] 8 9
Not Completed 5 1
Reason Not Completed
Withdrawal by Subject             5             1
[1]
Last Observation Carried Forward for 10 treatment and 9 wait list who completed Week 9 Assessment
Arm/Group Title Parent Child Interaction Therapy Wait List Control Total
Hide Arm/Group Description

Families will either receive Parent Child Interaction Therapy or be placed on a wait-list control group

Parent Child Interaction Therapy: Parent-Child Interaction Therapy (PCIT) is a research-supported parent coaching intervention that has been found to be highly effective among typically developing preschoolers presenting with a range of mental health concerns, especially defiance and noncompliance.6 PCIT holds considerable promise as a potentially effective treatment for children with Autism Spectrum Disorder because it directly addresses the behaviors parents of children with ASD report to be most problematic for them - defiance, stubbornness, and temper tantrums. PCIT is theoretically consistent with other approaches that have shown promise in treating ASD (i.e., behaviorally-based); however, PCIT is unique in that it incorporates a socially-based initial phase which may have some unique benefits for children with ASD.

Families will wait 18 weeks for treatment, serving as controls. Total of all reporting groups
Overall Number of Baseline Participants 13 10 23
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 13 participants 10 participants 23 participants
63.62  (17.08) 67.0  (16.31) 65.087  (16.45631)
[1]
Measure Description: Child's age at the beginning of the study
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 10 participants 23 participants
Female
1
   7.7%
1
  10.0%
2
   8.7%
Male
12
  92.3%
9
  90.0%
21
  91.3%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
African American Number Analyzed 13 participants 10 participants 23 participants
1
   7.7%
0
   0.0%
1
   4.3%
Asian Number Analyzed 13 participants 10 participants 23 participants
1
   7.7%
0
   0.0%
1
   4.3%
Caucasian Number Analyzed 13 participants 10 participants 23 participants
11
  84.6%
10
 100.0%
21
  91.3%
Hispanic Number Analyzed 13 participants 10 participants 23 participants
0
   0.0%
0
   0.0%
0
   0.0%
Native American Number Analyzed 13 participants 10 participants 23 participants
0
   0.0%
0
   0.0%
0
   0.0%
Mixed Race Number Analyzed 13 participants 10 participants 23 participants
0
   0.0%
0
   0.0%
0
   0.0%
Peabody Picture Vocabulary Test   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 12 participants 10 participants 22 participants
97.83  (13.27) 105.20  (16.24) 101.18  (14.81)
[1]
Measure Description: Peabody Picture Vocabulary Test Raw Score - IV PPVT-IV is a test for a child's receptive vocabulary, with higher scores indicating greater verbal ability and scholastic skills. Range for the raw score is 20-160.
[2]
Measure Analysis Population Description: Missing data for one participant
Intelligence Quotient (IQ)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 13 participants 10 participants 23 participants
93.38  (15.68) 103.60  (21.29) 97.83  (19.02)
[1]
Measure Description:

A full scale intelligence quotient (IQ) score provided by the Stanford-Binet Intelligence Scales, K-SEALS, WPPSI-IV.

IQ tests have range of 0-200. Higher IQ scores from any measure indicate greater cognitive capacity with 90-109 considered average.

Parental Stress Index   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
PSI Defensive Responding Number Analyzed 13 participants 10 participants 23 participants
19.62  (5.55) 19.30  (6.88) 19.48  (6.01)
Parent Distress Subscale Score Number Analyzed 13 participants 10 participants 23 participants
32.31  (9.38) 31.30  (10.25) 31.87  (9.56)
Parent-Child Dysfunctional Interaction Subscale Sc Number Analyzed 13 participants 10 participants 23 participants
32.54  (7.58) 28.80  (8.68) 30.91  (8.11)
Difficult Child Subscale Score Number Analyzed 13 participants 10 participants 23 participants
43.15  (5.71) 40.80  (6.83) 42.13  (6.19)
Total Stress Number Analyzed 13 participants 10 participants 23 participants
108.00  (18.75) 101.00  (22.32) 104.96  (20.20)
[1]
Measure Description: Parental Stress Index-4 Short Form (PSI):Total Stress Scale, total of subscales, range 36-180, higher indicating more parental stress. Defensive Responding, range 7 - 35. Lower scores indicate higher defensive responding from parents. Parental Distress, range 12- 60. Higher scores indicate more parental stress. Parent-Child Dysfunctional Interaction subscale, range 12 - 60. Higher scores indicate parents feel their child is not meeting their expectations when interacting. Difficult Child, range is 12 - 60. Higher scores indicate that parents view their child to be difficult to parent.
Eyberg Child Behavior Inventory   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Intensity Number Analyzed 13 participants 10 participants 23 participants
166.00  (29.8) 157.30  (21.0) 162.22  (26.1)
Problem Number Analyzed 13 participants 10 participants 23 participants
19.46  (8.56) 20.00  (5.66) 19.70  (7.29)
[1]
Measure Description:

Eyberg Child Behavior Inventory (ECBI):

Intensity score range is 36 - 252, with higher scores indicating a higher frequency of problem behaviors.

The ECBI contains the Problem Score calculated from 36 items rated on whether the particular behavior is considered by the to be a problem (yes) or not (no).

Problem score range is from a minimum of 0 - 36, with higher scores indicating more behaviors that a parent considers to be a problem.

Dyadic Parent-Child Interaction Coding   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Frequency of Behavior
Positive Skills Number Analyzed 12 participants 10 participants 22 participants
6.67  (4.23) 8.30  (6.13) 7.41  (5.11)
Negative Skills Number Analyzed 12 participants 10 participants 22 participants
73.92  (21.66) 97.10  (27.60) 84.45  (26.68)
[1]
Measure Description:

The Dyadic Parent-Child Interaction Coding System (DPICS) codes frequency of behaviors that occur during five minutes of child lead play, then parent lead play, and then clean-up.

Positive Skills was the total frequency of behavioral descriptions, reflections, and labeled praise throughout the three conditions.

Negative skills score was a combination of the total frequency of questions and negative talk throughout all conditions, as well as total commands during child lead play. It was expected that parent would give commands during parent-lead play or clean-up.

[2]
Measure Analysis Population Description: Data missing for one participant
Social Responsiveness Scale 2   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
SRS Total Raw Score Number Analyzed 13 participants 10 participants 23 participants
99.08  (24.65) 88.30  (21.74) 94.39  (23.55)
SRS Awareness Raw Score Number Analyzed 13 participants 10 participants 23 participants
13.62  (2.75) 12.20  (3.77) 13.00  (3.23)
SRS Cognition Raw Score Number Analyzed 13 participants 10 participants 23 participants
17.92  (5.96) 15.10  (3.54) 16.70  (5.16)
SRS Communication Raw Score Number Analyzed 13 participants 10 participants 23 participants
32.15  (10.47) 30.40  (7.86) 31.39  (9.27)
SRS Motivation Raw Score Number Analyzed 13 participants 10 participants 23 participants
16.38  (4.86) 12.20  (3.68) 14.57  (4.78)
SRS Restricted and Repetitive Behaviors Raw Score Number Analyzed 13 participants 10 participants 23 participants
19.00  (7.44) 18.40  (7.07) 18.74  (7.12)
[1]
Measure Description: Social Responsiveness Scale 2nd edition (SRS-2). SRS-2 Total Score is sum of subscales, for all subscales, higher scores mean more impairment. Total score range is 0-195. Social Awareness measures social awareness impairment, range 0-24. Social Cognition measures social cognition impairment, range 0-36. Social Communication measures social communication impairment, range 0-66. Social Motivation measures social motivation impairment, range 0-33. Restricted and Repetitive Behaviors measures restricted and repetitive behaviors, range 0-36.
1.Primary Outcome
Title Eyberg Child Behavior Inventory
Hide Description

Eyberg Child Behavior Inventory (ECBI). For families receiving PCIT training, the ECBI will be completed at screen, at each PCIT training visit and at the 12-week post-treatment visit. Wait-list control families will complete the ECBI at screen as well as at weeks 9 and 18. Reported week 9.

The ECBI contains the Intensity Score calculated from 36 items rated on frequency of behavior from 1 (Never) to 7 (Always).

Intensity score range is 36-252, with higher scores indicating a higher frequency of problem behaviors.

The ECBI contains the Problem Score calculated from 36 items rated on whether the particular behavior is considered by the to be a problem (yes) or not (no).

Problem score range is 0-36, with higher scores indicating a higher frequency of problem behaviors.

Time Frame Week 9
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who dropped out prior to Week 9 (2 in treatment group, 1 in wait list control) were not included in analysis.
Arm/Group Title Parent Child Interaction Therapy Wait List Control
Hide Arm/Group Description:

Families will either receive Parent Child Interaction Therapy or be placed on a wait-list control group

Parent Child Interaction Therapy: Parent-Child Interaction Therapy (PCIT) is a research-supported parent coaching intervention that has been found to be highly effective among typically developing preschoolers presenting with a range of mental health concerns, especially defiance and noncompliance.6 PCIT holds considerable promise as a potentially effective treatment for children with ASD because it directly addresses the behaviors parents of children with ASD report to be most problematic for them - defiance, stubbornness, and temper tantrums. PCIT is theoretically consistent with other approaches that have shown promise in treating ASD (i.e., behaviorally-based); however, PCIT is unique in that it incorporates a socially-based initial phase which may have some unique benefits for children with ASD.

Families will wait 18 weeks for treatment, serving as controls.
Overall Number of Participants Analyzed 10 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
ECBI Intensity Score 132.50  (42.62) 154.33  (25.60)
ECBI Problem Score 18.9  (9.65) 19.11  (6.45)
2.Primary Outcome
Title Eyberg Child Behavior Inventory
Hide Description

Eyberg Child Behavior Inventory (ECBI). For families receiving PCIT training, the ECBI will be completed at screen, at each PCIT training visit and at the 12-week post-treatment visit. Wait-list control families will complete the ECBI at screen as well as at weeks 9 and 18. Reported week 18

The ECBI contains the Intensity Score calculated from 36 items rated on frequency of behavior from 1 (Never) to 7 (Always).

Intensity score range is 36-252, with higher scores indicating a higher frequency of problem behaviors.

The ECBI contains the Problem Score calculated from 36 items rated on whether the particular behavior is considered by the to be a problem (yes) or not (no).

Problem score range is 0-36, with higher scores indicating a higher frequency of problem behaviors.

Time Frame Week 18
Hide Outcome Measure Data
Hide Analysis Population Description
Following the intent-to-treat principle, last observation carried forward for 2 subjects in treatment group who dropped out after Week 9. Subjects who dropped out prior to Week 9 (2 in treatment group, 1 in wait list control) were not included in analysis.
Arm/Group Title Parent Child Interaction Therapy Wait List Control
Hide Arm/Group Description:

Families will either receive Parent Child Interaction Therapy or be placed on a wait-list control group

Parent Child Interaction Therapy: Parent-Child Interaction Therapy (PCIT) is a research-supported parent coaching intervention that has been found to be highly effective among typically developing preschoolers presenting with a range of mental health concerns, especially defiance and noncompliance.6 PCIT holds considerable promise as a potentially effective treatment for children with ASD because it directly addresses the behaviors parents of children with ASD report to be most problematic for them - defiance, stubbornness, and temper tantrums. PCIT is theoretically consistent with other approaches that have shown promise in treating ASD (i.e., behaviorally-based); however, PCIT is unique in that it incorporates a socially-based initial phase which may have some unique benefits for children with ASD.

Families will wait 18 weeks for treatment, serving as controls.
Overall Number of Participants Analyzed 10 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
ECBI Intensity Score 115.20  (41.54) 148.67  (25.25)
ECBI Problem Score 14.10  (10.54) 19.67  (5.00)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Parent Child Interaction Therapy, Wait List Control
Comments Comparison of ECBI Problem Score between Week 18 scores, 1 sided test for Treatment Group Superiority
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .080
Comments No adjustment for multiple comparisons.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Parent Child Interaction Therapy, Wait List Control
Comments Comparison of ECBI Intensity Score between Week 18 scores, 1 sided test for Treatment Group Superiority
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .026
Comments No adjustment for multiple comparisons.
Method t-test, 1 sided
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Parent Child Interaction Therapy, Wait List Control
Comments Mixed Model Analysis of ECBI Intensity Scores, with variables of Timepoint, Treatment Assignment, and Timepoint*Treatment Assignment interaction. Random intercept used.
Type of Statistical Test Other
Comments Type III Tests of Fixed Effects
Statistical Test of Hypothesis P-Value <.001
Comments Mixed Model Analysis - Significance of Timepoint within the model in determining the effectiveness of assigned treatment.
Method Mixed Models Analysis
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Parent Child Interaction Therapy, Wait List Control
Comments Mixed Model Analysis of ECBI Intensity Scores, with variables of Timepoint, Treatment Assignment, and Timepoint*Treatment Assignment interaction. Random intercept used.
Type of Statistical Test Other
Comments Type III Tests of Fixed Effects
Statistical Test of Hypothesis P-Value .182
Comments Mixed Model Analysis - Significance of Treatment Assignment within the model in determining the effectiveness of assigned treatment.
Method Mixed Models Analysis
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Parent Child Interaction Therapy, Wait List Control
Comments Mixed Model Analysis of ECBI Intensity Scores, with variables of Timepoint, Treatment Assignment, and Timepoint*Treatment Assignment interaction. Random intercept used.
Type of Statistical Test Other
Comments Type III Tests of Fixed Effects
Statistical Test of Hypothesis P-Value .015
Comments Mixed Model Analysis - Significance of Treatment Assignment and Timepoint Interaction Term within the model in determining the effectiveness of assigned treatment.
Method Mixed Models Analysis
Comments [Not Specified]
3.Secondary Outcome
Title Parental Stress Index-4 Short Form
Hide Description

Parental Stress Index-4 Short Form (PSI) is comprised of several subscales that are independently measured and also combined to create a total score. Scores are calculated from 36 questions that rated as Strongly Agree/Agree/Not Sure/Disagree/Strongly Disagree by the parents. Ratings are attached to a 5-point Likert scale.

PSI Defensive Responding subscale range: 7-35. Lower scores indicate higher defensive responding from parents.

For the PSI Parental Distress subscale, range 12-60. Higher scores indicate higher parental stress in the parenting.

For the PSI Parent-Child Dysfunctional Interaction subscale, range 12-60. Higher scores indicate parents feel their child is not meeting their expectations when interacting.

For the PSI Difficult Child subscale, range 12-60. Higher scores indicates parents view their child to be difficult to parent.

For PSI Total Stress, range 43-215. Higher scores indicate higher stress.

Time Frame Week 18
Hide Outcome Measure Data
Hide Analysis Population Description
Following the intent-to-treat principle, last observation carried forward for 2 subjects in treatment group who dropped out after Week 9. Subjects who dropped out prior to Week 9 (2 in treatment group, 1 in wait list control) were not included in analysis.
Arm/Group Title Parent Child Interaction Therapy Wait List Control
Hide Arm/Group Description:

Families will either receive Parent Child Interaction Therapy or be placed on a wait-list control group

Parent Child Interaction Therapy: Parent-Child Interaction Therapy (PCIT) is a research-supported parent coaching intervention that has been found to be highly effective among typically developing preschoolers presenting with a range of mental health concerns, especially defiance and noncompliance.6 PCIT holds considerable promise as a potentially effective treatment for children with ASD because it directly addresses the behaviors parents of children with ASD report to be most problematic for them - defiance, stubbornness, and temper tantrums. PCIT is theoretically consistent with other approaches that have shown promise in treating ASD (i.e., behaviorally-based); however, PCIT is unique in that it incorporates a socially-based initial phase which may have some unique benefits for children with ASD.

Families will wait 18 weeks for treatment, serving as controls.
Overall Number of Participants Analyzed 10 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
PSI Defensive Responding 17.70  (7.21) 20.33  (4.77)
Parent Distress Subscale Score 29.10  (12.28) 33.44  (9.53)
Parent-Child Dysfunctional Interaction Subscale 28.80  (7.98) 27.44  (7.32)
Difficult Child Subscale Score 38.20  (12.59) 43.56  (5.50)
Total Stress 96.10  (28.67) 104.56  (18.21)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Parent Child Interaction Therapy, Wait List Control
Comments Comparison of PSI Parental Distress between Week 18 scores, 1 sided test for Treatment Group Superiority
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .203
Comments No adjustment for multiple comparisons.
Method t-test, 1 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Parent Child Interaction Therapy, Wait List Control
Comments Comparison of PSI Parent-Child Dysfunctional Interaction between Week 18 scores, 1 sided test for Treatment Group Superiority
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.17
Comments No adjustment for multiple comparisons
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Parent Child Interaction Therapy, Wait List Control
Comments Comparison of PSI Difficult Child between Week 18 scores, 1 sided test for Treatment Group Superiority
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.308
Comments No adjustment for multiple comparisons.
Method t-test, 1 sided
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Parent Child Interaction Therapy, Wait List Control
Comments Comparison of PSI Total Score between Week 18 scores, 1 sided test for Treatment Group Superiority
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .413
Comments No adjustment for multiple comparisons.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
4.Secondary Outcome
Title Social Responsiveness Scale 2 Score
Hide Description Social Responsiveness Scale 2nd edition (SRS-2). SRS-2 Total Score is sum of subscales, higher scores mean more impairment. Range 0-195. Social Awareness measures social awareness impairment, higher scores mean more impairment. Range 0-24. Social Cognition measures social cognition impairment, higher scores mean more impairment. Range 0-36. Social Communication measures social communication impairment, higher scores mean more impairment. Range 0-66. Social Motivation measures social motivation impairment, higher scores means more impairment. Range 0 - 33. Restricted and Repetitive Behaviors measures restricted and repetitive behaviors, with higher scores indicating more impairment. Range 0 - 36.
Time Frame Week 9
Hide Outcome Measure Data
Hide Analysis Population Description
Following the intent-to-treat principle, last observation carried forward for 2 subjects in treatment group who dropped out after Week 9. Subjects who dropped out prior to Week 9 (2 in treatment group, 1 in wait list control) were not included in analysis.
Arm/Group Title Parent Child Interaction Therapy Wait List Control
Hide Arm/Group Description:

Families will either receive Parent Child Interaction Therapy or be placed on a wait-list control group

Parent Child Interaction Therapy: Parent-Child Interaction Therapy (PCIT) is a research-supported parent coaching intervention that has been found to be highly effective among typically developing preschoolers presenting with a range of mental health concerns, especially defiance and noncompliance.6 PCIT holds considerable promise as a potentially effective treatment for children with ASD because it directly addresses the behaviors parents of children with ASD report to be most problematic for them - defiance, stubbornness, and temper tantrums. PCIT is theoretically consistent with other approaches that have shown promise in treating ASD (i.e., behaviorally-based); however, PCIT is unique in that it incorporates a socially-based initial phase which may have some unique benefits for children with ASD.

Families will wait 18 weeks for treatment, serving as controls.
Overall Number of Participants Analyzed 10 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
Total Raw Score 91.20  (34.31) 92.22  (17.65)
Awareness Raw Score 13.20  (3.19) 12.78  (2.11)
Cognition Raw Score 15.80  (7.30) 16.00  (3.04)
Communication Raw Score 30.80  (13.31) 32.78  (7.58)
Motivation Raw Score 14.40  (5.74) 12.22  (3.38)
Restricted and Repetitive Behaviors Raw Score 17.00  (8.71) 18.44  (7.21)
5.Secondary Outcome
Title Social Responsiveness Scale 2 Score
Hide Description Social Responsiveness Scale 2nd edition (SRS-2). SRS-2 Total Score is sum of subscales, higher scores mean more impairment. Range 0-195. Social Awareness measures social awareness impairment, higher scores mean more impairment. Range 0-24. Social Cognition measures social cognition impairment, higher scores mean more impairment. Range 0-36. Social Communication measures social communication impairment, higher scores mean more impairment. Range 0-66. Social Motivation measures social motivation impairment, higher scores means more impairment. Range 0 - 33. Restricted and Repetitive Behaviors measures restricted and repetitive behaviors, with higher scores indicating more impairment. Range 0 - 36.
Time Frame Week 18
Hide Outcome Measure Data
Hide Analysis Population Description
Data missing from some participants. Following the intent-to-treat principle, last observation carried forward for 2 subjects in treatment group who dropped out after Week 9. Subjects who dropped out prior to Week 9 (2 in treatment group, 1 in wait list control) were not included in analysis.
Arm/Group Title Parent Child Interaction Therapy Wait List Control
Hide Arm/Group Description:

Families will either receive Parent Child Interaction Therapy or be placed on a wait-list control group

Parent Child Interaction Therapy: Parent-Child Interaction Therapy (PCIT) is a research-supported parent coaching intervention that has been found to be highly effective among typically developing preschoolers presenting with a range of mental health concerns, especially defiance and noncompliance.6 PCIT holds considerable promise as a potentially effective treatment for children with ASD because it directly addresses the behaviors parents of children with ASD report to be most problematic for them - defiance, stubbornness, and temper tantrums. PCIT is theoretically consistent with other approaches that have shown promise in treating ASD (i.e., behaviorally-based); however, PCIT is unique in that it incorporates a socially-based initial phase which may have some unique benefits for children with ASD.

Families will wait 18 weeks for treatment, serving as controls.
Overall Number of Participants Analyzed 10 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
Total Raw Score 80.00  (28.25) 88.22  (29.12)
Awareness Raw Score 12.40  (2.67) 12.11  (4.65)
Cognition Raw Score 14.60  (5.97) 15.89  (4.08)
Communication Raw Score 27.10  (10.26) 30.67  (11.25)
Motivation Raw Score 11.10  (5.38) 11.44  (4.59)
Restricted and Repetitive Behaviors Raw Score 14.80  (8.38) 18.11  (8.54)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Parent Child Interaction Therapy, Wait List Control
Comments Comparison of SRS Total Score between Week 18 scores, 1 sided test for Treatment Group Superiority
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.271
Comments No adjustment for multiple comparisons.
Method t-test, 1 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Parent Child Interaction Therapy, Wait List Control
Comments Comparison of SRS Awareness Score between Week 18 scores, 1 sided test for Treatment Group Superiority
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .434
Comments No adjustment for multiple comparisons.
Method t-test, 1 sided
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Parent Child Interaction Therapy, Wait List Control
Comments Comparison of SRS Cognition Scores between Week 18 scores, 1 sided test for Treatment Group Superiority
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .298
Comments No adjustment for multiple comparisons.
Method t-test, 1 sided
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Parent Child Interaction Therapy, Wait List Control
Comments Comparison of SRS Communication Score between Week 18 scores, 1 sided test for Treatment Group Superiority
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .294
Comments No adjustment for multiple comparisons.
Method t-test, 1 sided
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Parent Child Interaction Therapy, Wait List Control
Comments Comparison of SRS Motivation between Week 18 scores, 1 sided test for Treatment Group Superiority
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .441
Comments No adjustment for multiple comparisons.
Method t-test, 1 sided
Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Parent Child Interaction Therapy, Wait List Control
Comments Comparison of SRS Restricted and Repetitive Behavior Score between Week 18 scores, 1 sided test for Treatment Group Superiority
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .204
Comments No adjustment for multiple comparisons.
Method t-test, 1 sided
Comments [Not Specified]
6.Secondary Outcome
Title Dyadic Parent-Child Interaction Coding System Scores
Hide Description

The Dyadic Parent-Child Interaction Coding System (DPICS) codes frequency of behaviors that occur during five minutes of child-lead play, then parent-lead play, and then clean-up.

Positive Skills score is the total frequency of behavioral descriptions, reflections, and labeled praise throughout the three conditions.

Negative skills score is a combination of the total frequency of questions, negative talk, and indirect commands throughout all conditions, as well as direct commands during child lead play. It was expected that parents would give commands during parent-lead play or clean-up.

Time Frame Week 9
Hide Outcome Measure Data
Hide Analysis Population Description
Following the intent-to-treat principle, last observation carried forward for 2 subjects in treatment group who dropped out after Week 9. Subjects who dropped out prior to Week 9 (2 in treatment group, 1 in wait list control) were not included in analysis.
Arm/Group Title Parent Child Interaction Therapy Wait List Control
Hide Arm/Group Description:

Families will either receive Parent Child Interaction Therapy or be placed on a wait-list control group

Parent Child Interaction Therapy: Parent-Child Interaction Therapy (PCIT) is a research-supported parent coaching intervention that has been found to be highly effective among typically developing preschoolers presenting with a range of mental health concerns, especially defiance and noncompliance.6 PCIT holds considerable promise as a potentially effective treatment for children with ASD because it directly addresses the behaviors parents of children with ASD report to be most problematic for them - defiance, stubbornness, and temper tantrums. PCIT is theoretically consistent with other approaches that have shown promise in treating ASD (i.e., behaviorally-based); however, PCIT is unique in that it incorporates a socially-based initial phase which may have some unique benefits for children with ASD.

Families will wait 18 weeks for treatment, serving as controls.
Overall Number of Participants Analyzed 10 9
Mean (Standard Deviation)
Unit of Measure: frequency of behaviors
Negative Skills 35.2  (14.54) 81.78  (19.886)
Positive Skills 26.9  (16.28) 5.667  (5)
7.Secondary Outcome
Title Dyadic Parent-Child Interaction Coding System Scores
Hide Description

The Dyadic Parent-Child Interaction Coding System (DPICS) codes frequency of behaviors that occur during five minutes of child lead play, then parent lead play, and then clean-up.

Positive Skills score was the total frequency of behavioral descriptions, reflections, and labeled praise throughout the three conditions.

Negative skills score was a combination of the total frequency of questions, negative talk, and indirect commands throughout all conditions, as well as direct commands during child lead play. It was expected that parents would give commands during parent-lead play or clean-up.

Time Frame Week 18
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Hide Analysis Population Description
Following the intent-to-treat principle, last observation carried forward for 2 subjects in treatment group who dropped out after Week 9. Subjects who dropped out prior to Week 9 (2 in treatment group, 1 in wait list control) were not included in analysis.
Arm/Group Title Parent Child Interaction Therapy Wait List Control
Hide Arm/Group Description:

Families will either receive Parent Child Interaction Therapy or be placed on a wait-list control group

Parent Child Interaction Therapy: Parent-Child Interaction Therapy (PCIT) is a research-supported parent coaching intervention that has been found to be highly effective among typically developing preschoolers presenting with a range of mental health concerns, especially defiance and noncompliance.6 PCIT holds considerable promise as a potentially effective treatment for children with ASD because it directly addresses the behaviors parents of children with ASD report to be most problematic for them - defiance, stubbornness, and temper tantrums. PCIT is theoretically consistent with other approaches that have shown promise in treating ASD (i.e., behaviorally-based); however, PCIT is unique in that it incorporates a socially-based initial phase which may have some unique benefits for children with ASD.

Families will wait 18 weeks for treatment, serving as controls.
Overall Number of Participants Analyzed 10 9
Mean (Standard Deviation)
Unit of Measure: counts of behaviors
Negative Skills 22.2  (14.71) 76.44  (24.6)
Positive Skills 41.4  (23.98) 8.11  (6.29)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Parent Child Interaction Therapy, Wait List Control
Comments Comparison of DPICS Negative Skills between Week 18 scores, 1 sided test for Treatment Group Superiority
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments No adjustment for multiple comparisons.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Parent Child Interaction Therapy, Wait List Control
Comments Comparison of DPICS Positive Skills between Week 18 scores, 1 sided test for Treatment Group Superiority. Data transformed using a square root transformation.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments No adjustment for multiple comparisons.
Method t-test, 1 sided
Comments [Not Specified]
8.Secondary Outcome
Title Parental Stress Index Score
Hide Description Parental Stress Index-4 Short Form (PSI):Total Stress Scale, total of subscales, range 36-180, higher indicating more parental stress. Defensive Responding, range 7-35. Lower scores indicate higher defensive responding from parents. Parental Distress, range 12-60. Higher scores indicate more parental stress. Parent-Child Dysfunctional Interaction subscale, range 12-60. Higher scores indicate parents feel their child is not meeting their expectations when interacting. Difficult Child, range is 12-60. Higher scores indicate that parents view their child to be difficult to parent.
Time Frame Week 9
Hide Outcome Measure Data
Hide Analysis Population Description
Following the intent-to-treat principle, last observation carried forward for 2 subjects in treatment group who dropped out after Week 9. Subjects who dropped out prior to Week 9 (2 in treatment group, 1 in wait list control) were not included in analysis.
Arm/Group Title Parent Child Interaction Therapy Wait List Control
Hide Arm/Group Description:

Families will either receive Parent Child Interaction Therapy or be placed on a wait-list control group

Parent Child Interaction Therapy: Parent-Child Interaction Therapy (PCIT) is a research-supported parent coaching intervention that has been found to be highly effective among typically developing preschoolers presenting with a range of mental health concerns, especially defiance and noncompliance.6 PCIT holds considerable promise as a potentially effective treatment for children with ASD because it directly addresses the behaviors parents of children with ASD report to be most problematic for them - defiance, stubbornness, and temper tantrums. PCIT is theoretically consistent with other approaches that have shown promise in treating ASD (i.e., behaviorally-based); however, PCIT is unique in that it incorporates a socially-based initial phase which may have some unique benefits for children with ASD.

Families will wait 18 weeks for treatment, serving as controls.
Overall Number of Participants Analyzed 10 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
PSI DR 18.80  (7.15) 19.56  (5.41)
Parent Distress Subscale Score 31.30  (11.20) 31.44  (8.93)
Parent-Child Dysfunctional Interaction Subscale Sc 31.30  (9.26) 28.78  (11.65)
Difficult Child Subscale Score 41.30  (10.67) 41.11  (8.45)
Total Stress 103.90  (28.18) 101.33  (24.77)
Time Frame The time frame that information on adverse events was collected depended on which treatment assignment was made. For individuals who were assigned to immediate PCIT training, adverse event data was collected over a period of 18 - 30 weeks, dependent on the subject's ability to schedule training. For individuals on the wait list for PCIT, adverse event data was collected over a period of 30 - 48 weeks, dependent on the subject's ability to schedule training.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Parent Child Interaction Therapy Wait List Control
Hide Arm/Group Description

Families will either receive Parent Child Interaction Therapy or be placed on a wait-list control group

Parent Child Interaction Therapy: Parent-Child Interaction Therapy (PCIT) is a research-supported parent coaching intervention that has been found to be highly effective among typically developing preschoolers presenting with a range of mental health concerns, especially defiance and noncompliance.6 PCIT holds considerable promise as a potentially effective treatment for children with ASD because it directly addresses the behaviors parents of children with ASD report to be most problematic for them - defiance, stubbornness, and temper tantrums. PCIT is theoretically consistent with other approaches that have shown promise in treating ASD (i.e., behaviorally-based); however, PCIT is unique in that it incorporates a socially-based initial phase which may have some unique benefits for children with ASD.

Families will wait 18 weeks for treatment, serving as controls.
All-Cause Mortality
Parent Child Interaction Therapy Wait List Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/10 (0.00%) 
Hide Serious Adverse Events
Parent Child Interaction Therapy Wait List Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/10 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Parent Child Interaction Therapy Wait List Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/10 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Benjamin L. Handen, PhD
Organization: University of Pittsburgh
Phone: 412-235-5445
EMail: handenbl@upmc.edu
Layout table for additonal information
Responsible Party: Benjamin L Handen, PhD, BCBA-D, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02088905    
Other Study ID Numbers: 0031588
PRO023120445 ( Other Identifier: University of Pittsburgh IRB )
First Submitted: March 7, 2014
First Posted: March 17, 2014
Results First Submitted: July 7, 2017
Results First Posted: March 1, 2019
Last Update Posted: March 22, 2019