Integrated Parent Training for Treating Depression in Mothers of Children With Attention Deficit Hyperactivity Disorder - Full Text View

Sponsored by:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00316290

Purpose

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).

Condition	Intervention
Depression Attention Deficit Disorder With Hyperactivity	Behavioral: Integrated Parent Training Behavioral: Behavioral Parent Training

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder Depression

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Integrated Treatment for Depressed Mothers of ADHD Children

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

Maternal depression [ Time Frame: Measured post-treatment and at 3-month follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Maternal stress and cognitions [ Time Frame: Measured post-treatment and at 3-month follow-up ] [ Designated as safety issue: No ]
Child behavior and impairment [ Time Frame: Measured post-treatment and at 3-month follow-up ] [ Designated as safety issue: No ]
Self-report and observed parenting behaviors [ Time Frame: Measured post-treatment and at 3-month follow-up ] [ Designated as safety issue: No ]
Family functioning [ Time Frame: Measured post-treatment and at 3-month follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment:	98
Study Start Date:	April 2006
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Participants will receive integrated parent training.	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.
2: Active Comparator Parents will receive behavioral parent training.	Behavioral: Behavioral Parent Training Parents will receive behavioral training. Treatment will include weekly 2-hour sessions for 14 weeks.

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.

Eligibility

Ages Eligible for Study:	6 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00316290

Locations

United States, Maryland
University of Maryland, College Park
College Park, Maryland, United States, 20742

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Andrea M. Chronis, PhD

University of Maryland, College Park

More Information

Additional Information:

Click here for the Maryland ADHD Program Home Page This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	University of Maryland, College Park ( Andrea M. Chronis, PhD )
Study ID Numbers:	R34 MH073567, DSIR 84-CTS
Study First Received:	April 18, 2006
Last Updated:	April 8, 2009
ClinicalTrials.gov Identifier:	NCT00316290 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

ADHD
Cognitive Behavioral Therapy
Parent Training

Study placed in the following topic categories:

Signs and Symptoms
Depression
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Mental Disorders Diagnosed in Childhood
Mood Disorders

Neurologic Manifestations
Attention Deficit and Disruptive Behavior Disorders
Hyperkinesis
Depressive Disorder
Dyskinesias
Behavioral Symptoms

Additional relevant MeSH terms:

Depression
Disease
Nervous System Diseases
Attention Deficit and Disruptive Behavior Disorders
Depressive Disorder
Dyskinesias
Behavioral Symptoms
Signs and Symptoms

Pathologic Processes
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Mental Disorders Diagnosed in Childhood
Mood Disorders
Hyperkinesis
Neurologic Manifestations

ClinicalTrials.gov processed this record on May 07, 2009