- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00316290
Integrated Parent Training for Treating Depression in Mothers of Children With Attention Deficit Hyperactivity Disorder
Integrated Treatment for Depressed Mothers of ADHD Children
Study Overview
Status
Intervention / Treatment
Detailed Description
ADHD is one of the most common childhood mental disorders. Children with ADHD have impaired functioning in multiple settings, including home and school, and in relationships with peers. Parenting a child with ADHD can be discouraging and stressful. Research has shown that parent-child interactions are more negative among families with ADHD children. Additionally, families with children with ADHD experience increased parental stress, maternal depression, and marital distress, as compared to families with healthy children. These interactions may exacerbate the child's ADHD symptoms. Behavioral parent training has been used to improve parent-child relationships. This study will determine the effectiveness of integrated parent training versus standard behavioral parent training in treating depression and stress in mothers of children with ADHD.
Individuals interested in participating in this open-label study will first undergo an assessment of their eligibility for inclusion in the study. This session will last between 3 and 4 hours and will involve both the mother and the child. If eligible, mothers will be randomly assigned to receive either standard behavioral parent training or an integrated treatment, involving both behavioral parent training and cognitive-behavioral therapy targeted at coping with stressful parenting situations. The integrated treatment will also include a course on coping with depression. Both groups will meet for 2 hours every Wednesday evening for 14 weeks. Childcare will be provided, as well as free treatment for childrens' ADHD symptoms and mothers' depression. Both the child's and the mother's psychological functioning will be assessed upon study completion and at the 3-month follow-up visit.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maryland
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College Park, Maryland, United States, 20742
- University of Maryland, College Park
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Mothers:
- Scores at least 10 on the Beck Depression Inventory (BDI)-II scale on two occasions approximately 1 week apart
- Does not meet criteria for current substance abuse, psychosis, or bipolar disorder, which would likely warrant other immediate treatment
Children:
- Meets DSM-IV criteria for ADHD according to parent and teacher reports on rating scales and parent diagnostic interviews
- Estimated IQ of at least 70
- Aged between 6 and 12 years
- Lives with mother
Exclusion Criteria:
- Child has current Pervasive Development Disorder
- Mothers and children participating in psychosocial treatment that cannot be suspended
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Participants will receive integrated parent training.
|
Treatment will include behavioral parent training, a course on coping with depression, and cognitive-behavioral therapy targeted at coping with stressful parenting situations.
Treatment will include weekly 2-hour sessions for 14 weeks.
|
Active Comparator: 2
Parents will receive behavioral parent training.
|
Parents will receive behavioral training.
Treatment will include weekly 2-hour sessions for 14 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maternal depression
Time Frame: Measured post-treatment and at 3-month follow-up
|
Measured post-treatment and at 3-month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maternal stress and cognitions
Time Frame: Measured post-treatment and at 3-month follow-up
|
Measured post-treatment and at 3-month follow-up
|
Child behavior and impairment
Time Frame: Measured post-treatment and at 3-month follow-up
|
Measured post-treatment and at 3-month follow-up
|
Self-report and observed parenting behaviors
Time Frame: Measured post-treatment and at 3-month follow-up
|
Measured post-treatment and at 3-month follow-up
|
Family functioning
Time Frame: Measured post-treatment and at 3-month follow-up
|
Measured post-treatment and at 3-month follow-up
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Andrea M. Chronis, PhD, University of Maryland, College Park
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R34MH073567 (U.S. NIH Grant/Contract)
- DSIR 84-CTS (Division of Services and Intervention Research)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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