Guided Self-Help for Parents of Children With Attention-Deficit/Hyperactivity Disorder (ADHD)

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Manfred Doepfner, University of Cologne
ClinicalTrials.gov Identifier:
NCT01351246
First received: May 2, 2011
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

Cognitive-behavioral based guided self-help for parents of children with Attention-Deficit/Hyperactivity Disorder (ADHD) is investigated in a feasibility and effectiveness study. The treatment is offered under routine-care conditions of the health-care system in Germany. Practicability, treatment participation and effectiveness is documented and tested in a one-group pre-test/post-test design.


Condition Intervention
Attention-Deficit/Hyperactivity Disorder
Behavioral: CBT Based Self-help Workbook + Counseling Telephone

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Guided Self-Help for Parents of Children With Attention-Deficit/Hyperactivity Disorder (ADHD): A Feasibility and Effectiveness Study

Resource links provided by NLM:


Further study details as provided by University of Cologne:

Primary Outcome Measures:
  • Total score of the Symptom Checklist Attention-Deficit/Hyperactivity Disorder (SCL-ADHD, Döpfner, Görtz-Dorten & Lehmkuhl, 2008 [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    Questionnaire assesses the diagnostic criteria of DSM-IV and ICD-10 for ADHD. Informant is participating parent.


Secondary Outcome Measures:
  • Strengths & Difficulties Questionnaire (SDQ) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Questionnaire assesses comorbid symptoms. Informant is the participating parent.

  • Quality of Life Questionnaire KINDL (Ravens-Sieberer & Bullinger, 2000) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Questionnaire assesses child´s quality of life. Informant is participating parent.


Enrollment: 300
Study Start Date: May 2010
Study Completion Date: March 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention Behavioral: CBT Based Self-help Workbook + Counseling Telephone
Over a period of 12 months parents work through 8 self-help booklets and additionally receive 14 counseling telephone calls. The intervention has a cognitive-behavioral foundation and is based on the therapy manual "Therapy program for children with hyperactive and oppositional problem behavior THOP" (Döpfner, Schürmann, & Frölich, 2007) and the parent self-help book "Wackelpeter and Trotzkopf: Help for parents of children with hyperkinetic and oppositional behavior" (Döpfner, Schürmann, & Lehmkuhl, 2006). Primary purpose of counseling telephone calls is to clarify contents of the booklets and support parents in managing their homework assignments accompanied with each booklet.
Other Names:
  • Guided self help
  • behavioral treatment

Detailed Description:

Self-directed interventions may overcome many of the barriers associated with accessing face-to-face services, as there is lowered stigma and significantly reduced or eliminated cost, transport, and timing difficulties. Families can complete self-directed programs at home, in their own time and at their own pace. Furthermore self-administered programs are often very cost-effective and their use can ease the financial burden of mental health of the community. These parenting programs can be particularly effective by reaching the populace. Moreover in primary care settings where financial resources, time and expertise might be lacking to provide behavioral interventions, self-directed programs might be a promising tool for disseminating effective parenting interventions more widely.

Bibliotherapy is one form of self-directed therapy. In bibliotherapy a selected book is thought to meet the specific need of the person to be treated and reading is used as the therapeutic technique. In opposition to pure self-help programs, bibliotherapy in terms of guided self-help provides patients (or parents) with written instructions as well as therapeutic contacts at regular intervals. During these contacts, problems and questions can be discussed to give further support. Self-help interventions have already proven to be effective for adults with anxiety or affective disorders as well as for depressive adolescents. However there has only been little research concerning the reduction of children's behaviour problems through parental self-help programs under minimal contact conditions.

  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Child diagnosis of ADHD

Exclusion Criteria:

  • Language or reading difficulties of participating parent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01351246

Locations
Germany
Department of Child and Adolescent Psychiatry and Psychotherapy at the University of Cologne
Cologne, NRW, Germany, 50931
Sponsors and Collaborators
University of Cologne
Eli Lilly and Company
Investigators
Principal Investigator: Manfred Döpfner, PhD University of Cologne
  More Information

No publications provided

Responsible Party: Manfred Doepfner, Leading psychologist at the Department of Child and Adolescent Psychiatry, University of Cologne
ClinicalTrials.gov Identifier: NCT01351246     History of Changes
Other Study ID Numbers: ADHD-TEAM-01
Study First Received: May 2, 2011
Last Updated: April 14, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by University of Cologne:
Program Evaluation
ADHD

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Disease
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Pathologic Processes
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 29, 2014