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A Family Centered Intervention to Promote Optimal Child Development

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ClinicalTrials.gov Identifier: NCT01941186
Recruitment Status : Completed
First Posted : September 13, 2013
Results First Posted : August 30, 2016
Last Update Posted : October 21, 2016
Sponsor:
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label)
Condition Developmental Delays
Intervention Other: Patient Decision Aid
Enrollment 64
Recruitment Details Participants were recruited from 2 urban pediatric practice sites within the Children's Hospital of Philadelphia Pediatric Research Consortium, a primary care-based network including 31 practices in 2 states, between December 2013 and September 2014.
Pre-assignment Details 164 parent-child dyads were assessed for eligibility and 100 were excluded. Reasons for exclusion were primarily because potential subjects either not meeting eligibility criteria (i.e., already received early intervention) or they declined to participate. 64 parent-child dyads were consented and randomized.
Arm/Group Title Patient Decision Aid Routine Care
Hide Arm/Group Description

After positive screen for a developmental concern the intervention group received the Patient Decision Aid (PDA), as well as, a text message reminder to follow up with Early Intervention.

Patient Decision Aid: Short informational video on developmental delays and early intervention services aimed at helping parents make an informed decision about whether to pursue early intervention services.

After screening positive for a potential development delay those in the control received routine care, in this case, a handout explaining Early Intervention services.
Period Title: Randomization/Allocation to Study Group
Started 31 33
Completed 31 33
Not Completed 0 0
Period Title: Follow-up
Started 31 33
Completed 30 33
Not Completed 1 0
Reason Not Completed
Lost to Follow-up             1             0
Arm/Group Title Patient Decision Aid Routine Care Total
Hide Arm/Group Description

After positive screen for a developmental concern the intervention group received the Patient Decision Aid (PDA), as well as, a text message reminder to follow up with Early Intervention.

Patient Decision Aid: Short informational video on developmental delays and early intervention services aimed at helping parents make an informed decision about whether to pursue early intervention services.

After screening positive for a potential development delay those in the control arm received routine care, in this case, a handout explaining Early Intervention services. Total of all reporting groups
Overall Number of Baseline Participants 31 33 64
Hide Baseline Analysis Population Description
64 parent-child dyads were enrolled, randomized and included in the final analysis. 1 parent-child dyad who completed the intervention could not be contacted for follow-up to determine early intervention (EI) disposition within 1 year of enrollment. Intervention phase data was complete and is in the final analysis.
Age, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 31 participants 33 participants 64 participants
Child: Age 1-12 months 3 4 7
Child: Age 13-24 months 20 22 42
Child: Age 25-36 months 8 7 15
[1]
Measure Description: Child's Age
Age, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 31 participants 33 participants 64 participants
Parent: 20 years and Under 2 3 5
Parent: 21-30 Years 15 18 33
Parent: 31-40 Years 10 6 16
Parent: Over 40 Years 2 2 4
Parent: Unknown Age 2 4 6
[1]
Measure Description: Parent's Age
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 33 participants 64 participants
Female
13
  41.9%
12
  36.4%
25
  39.1%
Male
18
  58.1%
21
  63.6%
39
  60.9%
[1]
Measure Description: Child's Gender
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 33 participants 64 participants
Female
5
  16.1%
5
  15.2%
10
  15.6%
Male
26
  83.9%
28
  84.8%
54
  84.4%
[1]
Measure Description: Parent's Gender
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 31 participants 33 participants 64 participants
Black/African American 24 32 56
Other 7 1 8
[1]
Measure Description: Parent's Race
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 31 participants 33 participants 64 participants
31 33 64
Parent's Education  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 31 participants 33 participants 64 participants
Less than High School 1 4 5
High School Graduate 23 27 50
Post Secondary Education 7 2 9
Parent's Employment Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 31 participants 33 participants 64 participants
Employed 17 20 37
Unemployed 14 13 27
Parent's Marital Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 31 participants 33 participants 64 participants
Married/Living with Partner 13 13 26
Divorced/Separated 4 2 6
Never Married 14 18 32
1.Primary Outcome
Title Difference in the Number of Participants Who Completed Early Intervention Intake and Evaluation Visits Between Treatment Groups
Hide Description Completed intake and evaluation by the early intervention (EI) agency was assessed by parent report and by chart review. A member of the study team contacted parents within 6 months of the first study visit to obtain this information. Additionally, a chart review seeking written feedback information regarding referral disposition from the EI agency was completed.
Time Frame Up to 1 year after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
One parent-child dyad had missing information regarding EI intake and evaluation. Given the absence of information on referral outcome, this parent-child dyad was included in the final evaluation as having not received an EI intake and evaluation.
Arm/Group Title Patient Decision Aid Routine Care
Hide Arm/Group Description:

After positive screen for a developmental concern the intervention group received the Patient Decision Aid (PDA), as well as, a text message reminder to follow up with Early Intervention.

Patient Decision Aid: Short informational video on developmental delays and early intervention services aimed at helping parents make an informed decision about whether to pursue early intervention services.

After screening positive for a potential development delay those in the control received routine care, in this case, a handout explaining Early Intervention services.
Overall Number of Participants Analyzed 31 33
Measure Type: Number
Unit of Measure: participants
Early Intervention Intake 20 21
Early Intervention Evaluation 17 17
2.Secondary Outcome
Title Change in Parental Knowledge and Attitudes From Pre- to Post-Intervention
Hide Description Pre and post knowledge and attitudes regarding developmental delay and early intervention (EI) were assessed by asking participants to respond to 14 statements using a 6 point Likert scale that ranged from strongly disagree to strongly agree. Questions mapped to the video decision aid content viewed by participants. Participants in the intervention arm completed the questions before and after watching the video and participants in the control arm completed the questions sequentially. Secondary outcome measures assessed in the survey included Parent Uncertainty About Early Intervention and Parental Predisposition for Early Intervention.
Time Frame Up to 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
All parent-child dyads who were enrolled and randomized were included in the analysis.
Arm/Group Title Patient Decision Aid: Strongly Disagree Patient Decision Aid: Disagree Patient Decision Aid: Somewhat Disagree Patient Decision Aid: Somewhat Agree Patient Decision Aid: Agree Patient Decision Aid: Strongly Agree Routine Care: Strongly Disagree Routine Care: Disagree Routine Care: Somewhat Disagree Routine Care: Somewhat Agree Routine Care: Agree Routine Care: Strongly Agree
Hide Arm/Group Description:
Percentage of parents who answered "strongly disagree" to questions during pre and post intervention
Percentage of parents who answered "disagree" to questions during pre and post intervention
Percentage of parents who answered "somewhat disagree" to questions during pre and post
Percentage of parents who answered "somewhat agree" to questions during pre and post intervention
Percentage of parents who answered "agree" to questions during pre and post intervention
Percentage of parents who answered "Strongly Agree" to questions during pre and post intervention
Percentage of parents who answered "strongly disagree" to questions during pre and post intervention
Percentage of parents who answered "disagree" to questions during pre and post intervention
Percentage of parents who answered "somewhat disagree" to questions during pre and post intervention
Percentage of parents who answered "somewhat agree" to questions during pre and post intervention.
Percentage of parents who answered "agree" to questions during pre and post intervention
Percentage of parents who answered "strongly agree" to questions during pre and post intervention
Overall Number of Participants Analyzed 31 31 31 31 31 31 33 33 33 33 33 33
Measure Type: Number
Unit of Measure: percentage of participants
All learn to talk, walk, think @ same time (pre) 48 35 6 10 0 0 52 33 9 3 0 3
All learn to talk, walk, think @ same time (post) 42 35 3 6 3 9 52 30 9 6 3 0
Longer to talk, walk, think may be delayed (pre) 10 32 10 23 19 6 9 33 21 21 6 9
Longer to talk, walk, think may be delayed (post) 10 10 10 23 35 13 15 30 12 33 6 3
All with delays get better on their own (pre) 19 29 6 19 19 6 3 30 15 30 15 6
All with delays get better on their own (post) 16 39 10 29 3 3 18 21 21 24 9 6
Behavior/Learning probs in school w/o help (pre) 10 16 6 26 29 13 6 9 12 30 27 15
Behavior/Learning probs in school w/o help (post) 3 3 6 13 45 29 3 0 15 30 30 21
Know more about child's develop than others (pre) 10 10 10 19 19 32 6 24 12 33 15 9
Know more about child's develop than others (post) 10 6 6 29 29 19 6 12 15 24 27 15
If delayed want to work with child on my own (pre) 23 39 10 10 16 3 9 27 24 18 21 0
If delayed want to work with child on my own (pos) 23 35 16 16 3 6 6 27 21 9 18 18
EI helps kids w/develop delay (pre) 6 0 0 16 42 35 0 0 0 9 64 27
EI helps kids w/develop delay (post) 3 0 0 13 42 42 0 0 0 18 48 33
You have to pay for EI services (pre) 23 45 13 13 6 0 27 39 21 6 6 0
You have to pay for EI services (post) 55 35 0 6 3 0 39 45 9 3 3 0
EI services can be in home or daycare (pre) 6 3 3 6 51 29 0 0 3 6 48 42
EI services can be in home or daycare (post) 3 3 0 6 35 52 0 0 0 15 45 39
EI provider must come to home (pre) 13 16 16 23 19 13 9 36 18 15 12 9
EI provider must come to home (post) 10 23 10 23 23 13 12 7 15 21 18 6
Once EI starts you cannot stop (pre) 32 35 16 3 13 0 45 36 6 3 3 6
Once EI starts you cannot stop (post) 48 32 6 6 3 3 39 42 9 0 6 3
Studies show EI helps make progress (pre) 6 3 0 13 45 32 0 0 6 18 58 18
Studies show EI helps make progress (post) 3 0 0 10 42 45 0 0 6 9 58 27
Resources like EI can help my family & I (pre) 6 0 3 13 35 42 0 0 0 9 52 39
Resources like EI can help my family & I (post) 3 0 0 10 35 52 0 0 0 12 58 30
I'm comfortable with EI staff in my home (pre) 6 3 3 16 29 42 0 3 3 12 48 33
I'm comfortable w/EI staff in my home (post) 3 0 6 10 39 42 0 0 6 12 45 36
3.Other Pre-specified Outcome
Title Parent Uncertainty About Early Intervention
Hide Description Parental uncertainty about whether to enroll their child in Early Intervention will be evaluated using a survey.
Time Frame Up to 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
All survey data is presented collectively in Secondary Outcome Measure, "Change in Parental Knowledge and Attitudes From Pre- to Post-Intervention". A separate analysis was not completed.
Arm/Group Title Patient Decision Aid Routine Care
Hide Arm/Group Description:

After positive screen for a developmental concern the intervention group received the Patient Decision Aid (PDA), as well as, a text message reminder to follow up with Early Intervention.

Patient Decision Aid: Short informational video on developmental delays and early intervention services aimed at helping parents make an informed decision about whether to pursue early intervention services.

After screening positive for a potential development delay those in the control arm received routine care, in this case, a handout explaining Early Intervention services.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Other Pre-specified Outcome
Title Parental Predisposition for Early Intervention
Hide Description Parental predisposition for early intervention services will be measured using surveys.
Time Frame Up to 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
All survey data is presented collectively in Secondary Outcome Measure, "Change in Parental Knowledge and Attitudes From Pre- to Post-Intervention". A separate analysis was not completed.
Arm/Group Title Patient Decision Aid Routine Care
Hide Arm/Group Description:

After positive screen for a developmental concern the intervention group received the Patient Decision Aid (PDA), as well as, a text message reminder to follow up with Early Intervention.

Patient Decision Aid: Short informational video on developmental delays and early intervention services aimed at helping parents make an informed decision about whether to pursue early intervention services.

After screening positive for a potential development delay those in the control arm received routine care, in this case, a handout explaining Early Intervention services.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Other Pre-specified Outcome
Title Feasibility of the Patient Decision Aid
Hide Description The feasibility of the patient decision aid (PDA) will be measured by calculating the number of individuals who refuse to participate, time that it takes to complete the PDA, and the number of patients who complete the Early Intervention referral.
Time Frame Up to 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected regarding the time to complete PDA and/or number of Early Intervention referrals for the total population, thus data for this outcome measure was not able to be analyzed as outlined at the time of protocol development.
Arm/Group Title Patient Decision Aid Routine Care
Hide Arm/Group Description:

After positive screen for a developmental concern the intervention group received the Patient Decision Aid (PDA), as well as, a text message reminder to follow up with Early Intervention.

Patient Decision Aid: Short informational video on developmental delays and early intervention services aimed at helping parents make an informed decision about whether to pursue early intervention services.

After screening positive for a potential development delay those in the control arm received routine care, in this case, a handout explaining Early Intervention services.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Other Pre-specified Outcome
Title Acceptability of the Patient Decision Aid for Early Intervention Referral
Hide Description The acceptability of using the patient decision aid for early intervention will be assessed by having patients and providers complete surveys on the intervention.
Time Frame Up to 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
Provider information was not collected as outlined in the initial protocol design. All survey data is presented collectively in Secondary Outcome Measure, "Change in Parental Knowledge and Attitudes From Pre- to Post-Intervention". This includes elements of parent acceptability. A separate analysis was not completed.
Arm/Group Title Patient Decision Aid Routine Care
Hide Arm/Group Description:

After positive screen for a developmental concern the intervention group received the Patient Decision Aid (PDA), as well as, a text message reminder to follow up with Early Intervention.

Patient Decision Aid: Short informational video on developmental delays and early intervention services aimed at helping parents make an informed decision about whether to pursue early intervention services.

After screening positive for a potential development delay those in the control arm received routine care, in this case, a handout explaining Early Intervention services.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse events were monitored for the duration of participation (up to 1 year)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Patient Decision Aid Routine Care
Hide Arm/Group Description

After positive screen for a developmental concern the intervention group received the Patient Decision Aid (PDA), as well as, a text message reminder to follow up with Early Intervention.

Patient Decision Aid: Short informational video on developmental delays and early intervention services aimed at helping parents make an informed decision about whether to pursue early intervention services.

After screening positive for a potential development delay those in the control received routine care, in this case, a handout explaining Early Intervention services.
All-Cause Mortality
Patient Decision Aid Routine Care
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Patient Decision Aid Routine Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/31 (0.00%)   0/33 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Patient Decision Aid Routine Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/31 (0.00%)   0/33 (0.00%) 
Given that the study recruited a convenience sample from one primary care network, findings may not be generalizable to all settings. Also worth noting, EI services differ by state and some of the information is not applicable in all states.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Manuel Jimenez, MD, MS
Organization: Child Health Institute of New Jersey
Phone: 732-235-6230
Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT01941186     History of Changes
Other Study ID Numbers: 13-010441
First Submitted: September 9, 2013
First Posted: September 13, 2013
Results First Submitted: July 13, 2016
Results First Posted: August 30, 2016
Last Update Posted: October 21, 2016