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Integrated Parent Training for Treating Depression in Mothers of Children With Attention Deficit Hyperactivity Disorder

Primary Purpose

Depression, Attention Deficit Disorder With Hyperactivity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Integrated Parent Training
Behavioral Parent Training
Sponsored by
University of Maryland, College Park
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring ADHD, Cognitive Behavioral Therapy, Parent Training

Eligibility Criteria

6 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Maryland, College Park

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Participants will receive integrated parent training.

Parents will receive behavioral parent training.

Outcomes

Primary Outcome Measures

Maternal depression

Secondary Outcome Measures

Maternal stress and cognitions
Child behavior and impairment
Self-report and observed parenting behaviors
Family functioning

Full Information

First Posted
April 18, 2006
Last Updated
May 9, 2023
Sponsor
University of Maryland, College Park
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00316290
Brief Title
Integrated Parent Training for Treating Depression in Mothers of Children With Attention Deficit Hyperactivity Disorder
Official Title
Integrated Treatment for Depressed Mothers of ADHD Children
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, College Park
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

5. Study Description

Brief 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Attention Deficit Disorder With Hyperactivity
Keywords
ADHD, Cognitive Behavioral Therapy, Parent Training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Participants will receive integrated parent training.
Arm Title
2
Arm Type
Active Comparator
Arm Description
Parents will receive behavioral parent training.
Intervention Type
Behavioral
Intervention Name(s)
Integrated Parent Training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Parent Training
Intervention Description
Parents will receive behavioral training. Treatment will include weekly 2-hour sessions for 14 weeks.
Primary Outcome Measure Information:
Title
Maternal depression
Time Frame
Measured post-treatment and at 3-month follow-up
Secondary Outcome Measure Information:
Title
Maternal stress and cognitions
Time Frame
Measured post-treatment and at 3-month follow-up
Title
Child behavior and impairment
Time Frame
Measured post-treatment and at 3-month follow-up
Title
Self-report and observed parenting behaviors
Time Frame
Measured post-treatment and at 3-month follow-up
Title
Family functioning
Time Frame
Measured post-treatment and at 3-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea M. Chronis, PhD
Organizational Affiliation
University of Maryland, College Park
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Maryland, College Park
City
College Park
State/Province
Maryland
ZIP/Postal Code
20742
Country
United States

12. IPD Sharing Statement

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Integrated Parent Training for Treating Depression in Mothers of Children With Attention Deficit Hyperactivity Disorder

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