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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00316290
Other study ID # R34MH073567
Secondary ID R34MH073567DSIR
Status Completed
Phase N/A
First received
Last updated
Start date April 2006
Est. completion date December 2010

Study information

Verified date May 2023
Source University of Maryland, College Park
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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 attention deficit hyperactivity disorder (ADHD).


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.


Recruitment information / eligibility

Status Completed
Enrollment 98
Est. completion date December 2010
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender All
Age group 6 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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.
Behavioral Parent Training
Parents will receive behavioral training. Treatment will include weekly 2-hour sessions for 14 weeks.

Locations

Country Name City State
United States University of Maryland, College Park College Park Maryland

Sponsors (2)

Lead Sponsor Collaborator
University of Maryland, College Park National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maternal depression Measured post-treatment and at 3-month follow-up
Secondary Maternal stress and cognitions Measured post-treatment and at 3-month follow-up
Secondary Child behavior and impairment Measured post-treatment and at 3-month follow-up
Secondary Self-report and observed parenting behaviors Measured post-treatment and at 3-month follow-up
Secondary Family functioning Measured post-treatment and at 3-month follow-up
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