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Preventing Depression in the Children of Depressed African American Mothers

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Rhonda Boyd, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT00904917
First received: May 19, 2009
Last updated: October 17, 2014
Last verified: October 2014
Results First Received: September 26, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Prevention
Condition: Depression
Interventions: Behavioral: Prevention Intervention Project
Behavioral: Psychoeducation

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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.


Participant Flow:   Overall Study
    Adapted PIP (Mothers)     Adapted PIP (Children)     Lecture (Mothers)     Lecture (Children)  
STARTED     7     11     8     8  
COMPLETED     5     9     6     6  
NOT COMPLETED     2     2     2     2  
Lost to Follow-up                 2                 2                 2                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Adapted PIP (Mothers) Mothers of the mother-child dyad in the adapted PIP intervention.
Adapted PIP (Children) Children of the mother-child dyad in the adapted PIP intervention.
Lecture (Mothers) Mothers of the mother-child dyad in the lecture control group.
Lecture (Children) Children of the mother-child dyad in the lecture control group.
Total Total of all reporting groups

Baseline Measures
    Adapted PIP (Mothers)     Adapted PIP (Children)     Lecture (Mothers)     Lecture (Children)     Total  
Number of Participants  
[units: participants]
  7     11     8     8     34  
Age  
[units: participants]
         
<=18 years     0     11     0     8     19  
Between 18 and 65 years     7     0     8     0     15  
>=65 years     0     0     0     0     0  
Gender  
[units: participants]
         
Female     7     6     8     8     29  
Male     0     5     0     0     5  
Region of Enrollment  
[units: participants]
         
United States     7     11     8     8     34  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Children Depression Inventory (CDI)   [ Time Frame: Measured at baseline and at post-treatment (8 weeks after baseline) ]

2.  Primary:   Multidimensional Anxiety Scale for Children (MASC)   [ Time Frame: Measured at baseline and post-treatment (8 weeks after baseline) ]

3.  Secondary:   Understanding Mood Disorders Questionnaire (UMDQ)   [ Time Frame: Measured at baseline and post-treatment (8 weeks after baseline) ]

4.  Secondary:   Child's Report on Parental Behavior Inventory (CRPBI)   [ Time Frame: Measured at baseline and post-treatment (8 weeks after baseline) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Small sample size; Inadequate power to detect changes between groups; No-intervention comparison group; Differential attrition in the two groups favoring the comparison group


  More Information
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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
e-mail: boydr@email.chop.edu


No publications provided


Responsible Party: Rhonda Boyd, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT00904917     History of Changes
Other Study ID Numbers: 2004-10-4041, K01MH068619, DSIR 8K-RTCT, IRB NO: 2004-10-4041
Study First Received: May 19, 2009
Results First Received: September 26, 2013
Last Updated: October 17, 2014
Health Authority: United States: Federal Government