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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Andrea M. Chronis-Tuscano, University of Maryland
ClinicalTrials.gov Identifier:
NCT00316290
First received: April 18, 2006
Last updated: February 22, 2013
Last verified: February 2013
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Integrated Treatment for Depressed Mothers of ADHD Children

Resource links provided by NLM:


Further study details as provided by University of Maryland:

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
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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.
Active Comparator: 2
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
University of Maryland
Investigators
Principal Investigator: Andrea M. Chronis, PhD University of Maryland, College Park
  More Information

Additional Information:
No publications provided

Responsible Party: Andrea M. Chronis-Tuscano, Associate Professor - Psychology, University of Maryland
ClinicalTrials.gov Identifier: NCT00316290     History of Changes
Other Study ID Numbers: R34 MH073567, R34MH073567, DSIR 84-CTS
Study First Received: April 18, 2006
Last Updated: February 22, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Maryland:
ADHD
Cognitive Behavioral Therapy
Parent Training

Additional relevant MeSH terms:
Depression
Depressive Disorder
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Behavioral Symptoms
Mood Disorders
Mental Disorders
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on April 21, 2014