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

Attention-Deficit/Hyperactivity Disorder Clinical Trial

Official title:

Guided Self-Help for Parents of Children With Attention-Deficit/Hyperactivity Disorder (ADHD): A Feasibility and Effectiveness Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01351246
• Other study ID #: ADHD-TEAM-01
• Status: Completed
• Phase: N/A
• First received: May 2, 2011
• Last updated: April 14, 2014
• Start date: May 2010
• Est. completion date: March 2014

Study information

• Verified date: April 2014
• Source: University of Cologne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: March 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 12 Years

Eligibility

Inclusion Criteria:

• Child diagnosis of ADHD

Exclusion Criteria:

• Language or reading difficulties of participating parent

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention-Deficit/Hyperactivity Disorder
• Hyperkinesis

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.

Locations

Country	Name	City	State
Germany	Department of Child and Adolescent Psychiatry and Psychotherapy at the University of Cologne	Cologne	NRW

Sponsors (2)

Lead Sponsor	Collaborator
University of Cologne	Eli Lilly and Company

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total score of the Symptom Checklist Attention-Deficit/Hyperactivity Disorder (SCL-ADHD, Döpfner, Görtz-Dorten & Lehmkuhl, 2008	Questionnaire assesses the diagnostic criteria of DSM-IV and ICD-10 for ADHD. Informant is participating parent.	one year	Yes
Secondary	Strengths & Difficulties Questionnaire (SDQ)	Questionnaire assesses comorbid symptoms. Informant is the participating parent.	1 year	Yes
Secondary	Quality of Life Questionnaire KINDL (Ravens-Sieberer & Bullinger, 2000)	Questionnaire assesses child´s quality of life. Informant is participating parent.	1 year	Yes