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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01351246
Recruitment Status : Completed
First Posted : May 10, 2011
Last Update Posted : April 15, 2014
Eli Lilly and Company
Information provided by (Responsible Party):
Manfred Doepfner, University of Cologne

Brief Summary:
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 or disease Intervention/treatment
Attention-Deficit/Hyperactivity Disorder Behavioral: CBT Based Self-help Workbook + Counseling Telephone

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : May 2010
Primary Completion Date : February 2014
Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

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

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Child diagnosis of ADHD

Exclusion Criteria:

  • Language or reading difficulties of participating parent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01351246

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
Principal Investigator: Manfred Döpfner, PhD University of Cologne

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
First Posted: May 10, 2011    Key Record Dates
Last Update Posted: April 15, 2014
Last Verified: April 2014

Keywords provided by Manfred Doepfner, University of Cologne:
Program Evaluation

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms