Trial Outcomes & Findings for Preventing Depression in the Children of Depressed African American Mothers (NCT NCT00904917)
NCT ID: NCT00904917
Last Updated: 2014-10-20
Results Overview
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.
COMPLETED
PHASE1
34 participants
Measured at baseline and at post-treatment (8 weeks after baseline)
2014-10-20
Participant Flow
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.
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.
Participant milestones
| Measure |
Adapted PIP (Mothers)
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.
|
Adapted PIP (Children)
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
|
Lecture (Mothers)
Mothers who received education about depression.
Psychoeducation : Two 1-hour sessions focusing on psychoeducation about depression and its impact on children and the family.
|
Lecture (Children)
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
11
|
8
|
8
|
|
Overall Study
COMPLETED
|
5
|
9
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
2
|
2
|
Reasons for withdrawal
| Measure |
Adapted PIP (Mothers)
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.
|
Adapted PIP (Children)
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
|
Lecture (Mothers)
Mothers who received education about depression.
Psychoeducation : Two 1-hour sessions focusing on psychoeducation about depression and its impact on children and the family.
|
Lecture (Children)
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.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
2
|
2
|
Baseline Characteristics
Preventing Depression in the Children of Depressed African American Mothers
Baseline characteristics by cohort
| Measure |
Adapted PIP (Mothers)
n=7 Participants
Mothers of the mother-child dyad in the adapted PIP intervention.
|
Adapted PIP (Children)
n=11 Participants
Children of the mother-child dyad in the adapted PIP intervention.
|
Lecture (Mothers)
n=8 Participants
Mothers of the mother-child dyad in the lecture control group.
|
Lecture (Children)
n=8 Participants
Children of the mother-child dyad in the lecture control group.
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
11 participants
n=7 Participants
|
8 participants
n=5 Participants
|
8 participants
n=4 Participants
|
34 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Measured at baseline and at post-treatment (8 weeks after baseline)Population: 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).
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.
Outcome measures
| Measure |
Adapted PIP
n=11 Participants
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.
|
Lecture
n=8 Participants
Mothers received psychoeducation about depression. The intervention was psychoeducation.
|
Lecture (Mother)
Mothers received psychoeducation about depression.
|
Lecture (Child)
Mothers received psychoeducation about depression. The intervention was psychoeducation.
|
|---|---|---|---|---|
|
Children Depression Inventory (CDI)
Baseline scores
|
47.64 T scores
Standard Deviation 8.36
|
47.00 T scores
Standard Deviation 8.55
|
—
|
—
|
|
Children Depression Inventory (CDI)
Post-intervention scores (8 weeks from baseline)
|
42.11 T scores
Standard Deviation 2.98
|
43.83 T scores
Standard Deviation 5.27
|
—
|
—
|
PRIMARY outcome
Timeframe: Measured at baseline and post-treatment (8 weeks after baseline)Population: 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).
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.
Outcome measures
| Measure |
Adapted PIP
n=11 Participants
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.
|
Lecture
n=8 Participants
Mothers received psychoeducation about depression. The intervention was psychoeducation.
|
Lecture (Mother)
Mothers received psychoeducation about depression.
|
Lecture (Child)
Mothers received psychoeducation about depression. The intervention was psychoeducation.
|
|---|---|---|---|---|
|
Multidimensional Anxiety Scale for Children (MASC)
Baseline scores
|
50.64 T scores
Standard Deviation 8.43
|
52.50 T scores
Standard Deviation 10.07
|
—
|
—
|
|
Multidimensional Anxiety Scale for Children (MASC)
Post-intervention scores (8 weeks from baseline)
|
43.67 T scores
Standard Deviation 15.12
|
57.67 T scores
Standard Deviation 32.36
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured at baseline and post-treatment (8 weeks after baseline)Population: 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).
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.
Outcome measures
| Measure |
Adapted PIP
n=7 Participants
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.
|
Lecture
n=10 Participants
Mothers received psychoeducation about depression. The intervention was psychoeducation.
|
Lecture (Mother)
n=8 Participants
Mothers received psychoeducation about depression.
|
Lecture (Child)
n=8 Participants
Mothers received psychoeducation about depression. The intervention was psychoeducation.
|
|---|---|---|---|---|
|
Understanding Mood Disorders Questionnaire (UMDQ)
Baseline scores
|
23.86 units on a scale
Standard Deviation 3.93
|
14.70 units on a scale
Standard Deviation 5.72
|
24.25 units on a scale
Standard Deviation 3.41
|
13.13 units on a scale
Standard Deviation 5.57
|
|
Understanding Mood Disorders Questionnaire (UMDQ)
Post-intervention scores (8 weeks from baseline)
|
22.80 units on a scale
Standard Deviation 2.59
|
14.67 units on a scale
Standard Deviation 5.45
|
25.00 units on a scale
Standard Deviation 2.10
|
14.33 units on a scale
Standard Deviation 4.18
|
SECONDARY outcome
Timeframe: Measured at baseline and post-treatment (8 weeks after baseline)Population: 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).
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.
Outcome measures
| Measure |
Adapted PIP
n=7 Participants
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.
|
Lecture
n=11 Participants
Mothers received psychoeducation about depression. The intervention was psychoeducation.
|
Lecture (Mother)
n=8 Participants
Mothers received psychoeducation about depression.
|
Lecture (Child)
n=8 Participants
Mothers received psychoeducation about depression. The intervention was psychoeducation.
|
|---|---|---|---|---|
|
Child's Report on Parental Behavior Inventory (CRPBI)
Baseline scores
|
25.57 units on a scale
Standard Deviation 3.21
|
24.55 units on a scale
Standard Deviation 4.63
|
24.88 units on a scale
Standard Deviation 4.09
|
27.13 units on a scale
Standard Deviation 2.17
|
|
Child's Report on Parental Behavior Inventory (CRPBI)
Post-intervention scores (8 weeks from baseline)
|
26.40 units on a scale
Standard Deviation 3.36
|
24.67 units on a scale
Standard Deviation 3.46
|
25.33 units on a scale
Standard Deviation 4.68
|
25.00 units on a scale
Standard Deviation 4.98
|
Adverse Events
Adapted PIP
Lecture
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Rhonda C. Boyd, Ph.D.
Children's Hospital of Philadelphia
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place