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Preventing Depression in the Children of Depressed African American Mothers

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ClinicalTrials.gov Identifier: NCT00904917
Recruitment Status : Completed
First Posted : May 20, 2009
Results First Posted : October 20, 2014
Last Update Posted : October 20, 2014
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Rhonda Boyd, Children's Hospital of Philadelphia

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Prevention
Condition Depression
Interventions Behavioral: Prevention Intervention Project
Behavioral: Psychoeducation
Enrollment 34
Recruitment Details The majority of the mothers were recruited through newspaper ads while remaining participants were recruited from word of mouth, research studies, mental health clinics and other sources.
Pre-assignment Details Eighteen mothers completed the Structured Clinical Interview (SCID), with 16 being eligible to participate in the study, and 1 mother did not complete the baseline interview. Fifteen mothers (with 19 children) were randomized.
Arm/Group Title Adapted PIP (Mothers) Adapted PIP (Children) Lecture (Mothers) Lecture (Children)
Hide Arm/Group Description

Mothers participated in an adapted PIP for the families of children with a depressed African American mother.

Prevention Intervention Project : Eight 1-hour sessions, tailored as required to meet the clinical and cultural needs of each family. Intervention focuses on education, coping with stress, and cognitive-behavioral strategies.

Children of the mother-child dyad in the adapted PIP intervention for families of children with a depressed African American Mother.

Intervention Project: Eight 1 hour sessions, tailored as required to meet the clinical and cultural needs of each family. Intervention focuses on education, coping with stress, and cognitive-behavioral strategies

Mothers who received education about depression.

Psychoeducation : Two 1-hour sessions focusing on psychoeducation about depression and its impact on children and the family.

Children of mothers who received education about depression.

Psychoeducation : Two 1-hour sessions focusing on psychoeducation about depression and its impact on children and the family.

Period Title: Overall Study
Started 7 11 8 8
Completed 5 9 6 6
Not Completed 2 2 2 2
Reason Not Completed
Lost to Follow-up             2             2             2             2
Arm/Group Title Adapted PIP (Mothers) Adapted PIP (Children) Lecture (Mothers) Lecture (Children) Total
Hide Arm/Group Description Mothers of the mother-child dyad in the adapted PIP intervention. Children of the mother-child dyad in the adapted PIP intervention. Mothers of the mother-child dyad in the lecture control group. Children of the mother-child dyad in the lecture control group. Total of all reporting groups
Overall Number of Baseline Participants 7 11 8 8 34
Hide Baseline Analysis Population Description
The participant flow module is based on the number of mother-child dyads that completed the baseline assessment(s), while the overall number of participants is based on the number of mothers and children in the intervention and control groups.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 11 participants 8 participants 8 participants 34 participants
<=18 years
0
   0.0%
11
 100.0%
0
   0.0%
8
 100.0%
19
  55.9%
Between 18 and 65 years
7
 100.0%
0
   0.0%
8
 100.0%
0
   0.0%
15
  44.1%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 11 participants 8 participants 8 participants 34 participants
Female
7
 100.0%
6
  54.5%
8
 100.0%
8
 100.0%
29
  85.3%
Male
0
   0.0%
5
  45.5%
0
   0.0%
0
   0.0%
5
  14.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 7 participants 11 participants 8 participants 8 participants 34 participants
7 11 8 8 34
1.Primary Outcome
Title Children Depression Inventory (CDI)
Hide Description Children Depression Inventory (CDI; Kovacs, 1992) is a widely-used self-report scale of depressive symptoms suitable for use by youth ranging from 7 to 17 years. The CDI is a 27-item scale that is self-rated and symptom-oriented. The 27 items on the assessment are grouped into five major factor areas. The item score are rated 0-2 with a total scores summed and converted to T scores. The total T score ranges from 33 to 100 with high scores indicating higher levels of depressive symptoms.
Time Frame Measured at baseline and at post-treatment (8 weeks after baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
These scores are based on the CDI which was administered solely to the children of the dyadic mother-child intervention and control groups. Post-intervention scores based on 9 children in Adapted PIP (2 lost to follow-up) and 6 children in Lecture group (2 lost to follow-up).
Arm/Group Title Adapted PIP Lecture
Hide Arm/Group Description:

Participants (both mother and children) participated in an adapted cognitive family prevention program for the families of children with a depressed African American mother.

The intervention was the Prevention Intervention Project.

Mothers received psychoeducation about depression. The intervention was psychoeducation.
Overall Number of Participants Analyzed 11 8
Mean (Standard Deviation)
Unit of Measure: T scores
Baseline scores 47.64  (8.36) 47.00  (8.55)
Post-intervention scores (8 weeks from baseline) 42.11  (2.98) 43.83  (5.27)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adapted PIP, Lecture
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .015
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Primary Outcome
Title Multidimensional Anxiety Scale for Children (MASC)
Hide Description Multidimensional Anxiety Scale for Children (MASC; March et al., 1997) is a self-report instrument that measures a broad range of anxiety symptoms in youth. The MASC consists of 39 items using a 4-point Likert scale that are distributed across four major factors, three of which can be parsed into two subfactors each. Main and subfactors include (1) physical symptoms (tense/restless and somatic/autonomic), (2) social anxiety (humiliation/rejection and public performance fears), (3) harm avoidance (perfectionism and anxious coping), and (4) separation anxiety. Scores are summed and converted to T-scores. The total T score ranges from 25 to 90 with higher scores representing greater levels of anxiety.
Time Frame Measured at baseline and post-treatment (8 weeks after baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
These scores are based on the MASC which was administered solely to the children of the dyadic mother-child intervention and control groups. Post-intervention scores based on 9 children in Adapted PIP (2 lost to follow-up) and 6 children in Lecture group (2 lost to follow-up).
Arm/Group Title Adapted PIP Lecture
Hide Arm/Group Description:
Participants (both mother and children) participated in an adapted cognitive family prevention program for the families of children with a depressed African American mother. The intervention was the Prevention Intervention Project.
Mothers received psychoeducation about depression. The intervention was psychoeducation.
Overall Number of Participants Analyzed 11 8
Mean (Standard Deviation)
Unit of Measure: T scores
Baseline scores 50.64  (8.43) 52.50  (10.07)
Post-intervention scores (8 weeks from baseline) 43.67  (15.12) 57.67  (32.36)
3.Secondary Outcome
Title Understanding Mood Disorders Questionnaire (UMDQ)
Hide Description Understanding Mood Disorders Questionnaire (UMDQ; Gavazzi, Fristad, & Law, 1997) measures attributions and knowledge of symptoms, course, and treatment of mood disorders and a symptom checklist. It has 39 items and two subscales. A range of total score is 0 to 59. The first 20 questions are true/false questions and correct responses are scored 2 points each. Nineteen questions are a checklist of symptoms and correct identification of those depression and manic symptoms are scored 1 point each. All items are summed for a total score. Higher scores indicate greater knowledge of mood disorders. Both maternal and child reporters completed this measure.
Time Frame Measured at baseline and post-treatment (8 weeks after baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
These scores are based on the UMDQ, which was administered to both the mothers and their children of the dyadic mother-child intervention and control groups. Post-intervention scores based on 5 mothers and 9 children in Adapted PIP (4 participants lost to follow-up) and 6 mothers and 6 children in Lecture group (4 participants lost to follow-up).
Arm/Group Title Adapted PIP (Mother) Adapted PIP (Child) Lecture (Mother) Lecture (Child)
Hide Arm/Group Description:

Participants (both mother and children) participated in an adapted cognitive family prevention program for the families of children with a depressed African American mother.

The intervention was the Prevention Intervention Project.

Participants (both mother and children) participated in an adapted cognitive family prevention program for the families of children with a depressed African American mother. The intervention was the Prevention Intervention Project.
Mothers received psychoeducation about depression.
Mothers received psychoeducation about depression. The intervention was psychoeducation.
Overall Number of Participants Analyzed 7 10 8 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline scores 23.86  (3.93) 14.70  (5.72) 24.25  (3.41) 13.13  (5.57)
Post-intervention scores (8 weeks from baseline) 22.80  (2.59) 14.67  (5.45) 25.00  (2.10) 14.33  (4.18)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adapted PIP (Child), Lecture (Child)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .037
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
4.Secondary Outcome
Title Child's Report on Parental Behavior Inventory (CRPBI)
Hide Description Child's Report on Parental Behavior Inventory (CRPBI; Schludermann & Schludermann, 1970) assesses children's and parents’ perceptions of parental acceptance, permitting psychological autonomy, and level of parental control. The 10-item acceptance scale which assesses parental warmth was administered. The acceptable scale has items scored from 1 to 3 (not like me, somewhat like me, a lot like me). Items are summed with a total range is 10 to 30. Higher scores represents greater warmth exhibited by mother to child. Separate forms are available for both child and parent report.
Time Frame Measured at baseline and post-treatment (8 weeks after baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
These scores are based on the CRPBI, which was administered to both the mothers and their children of the dyadic mother-child intervention and control groups. Post-intervention scores based on 5 mothers and 9 children in Adapted PIP (4 participants lost to follow-up) and 6 mothers and 6 children in Lecture group (4 participants lost to follow-up).
Arm/Group Title Adapted PIP (Mother) Adapted PIP (Child) Lecture (Mother) Lecture (Child)
Hide Arm/Group Description:

Participants (both mother and children) participated in an adapted cognitive family prevention program for the families of children with a depressed African American mother.

The intervention was the Prevention Intervention Project.

Participants (both mother and children) participated in an adapted cognitive family prevention program for the families of children with a depressed African American mother.

The intervention was the Prevention Intervention Project.

Mothers received psychoeducation about depression. The intervention was psychoeducation.
Mothers received psychoeducation about depression. The intervention was psychoeducation.
Overall Number of Participants Analyzed 7 11 8 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline scores 25.57  (3.21) 24.55  (4.63) 24.88  (4.09) 27.13  (2.17)
Post-intervention scores (8 weeks from baseline) 26.40  (3.36) 24.67  (3.46) 25.33  (4.68) 25.00  (4.98)
Time Frame Adverse event was collected for 1 year.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Adapted PIP Lecture
Hide Arm/Group Description Participants (both mother and children) participated in an adapted cognitive family prevention program for the families of children with a depressed African American mother. The intervention was the Preventive Intervention Project. Mothers received psychoeducation about depression.
All-Cause Mortality
Adapted PIP Lecture
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Adapted PIP Lecture
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/16 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Adapted PIP Lecture
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/16 (0.00%) 
Small sample size; Inadequate power to detect changes between groups; No-intervention comparison group; Differential attrition in the two groups favoring the comparison group
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Rhonda C. Boyd, Ph.D.
Organization: Children's Hospital of Philadelphia
Phone: 215-590-3945
Responsible Party: Rhonda Boyd, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT00904917     History of Changes
Other Study ID Numbers: 2004-10-4041
K01MH068619 ( U.S. NIH Grant/Contract )
DSIR 8K-RTCT ( Other Identifier: NIMH DSIR )
IRB NO: 2004-10-4041 ( Other Identifier: IRB No. )
First Submitted: May 19, 2009
First Posted: May 20, 2009
Results First Submitted: September 26, 2013
Results First Posted: October 20, 2014
Last Update Posted: October 20, 2014