Guided Self-Help for Parents of Children With Attention-Deficit/Hyperactivity Disorder (ADHD)
Primary Purpose
Attention-Deficit/Hyperactivity Disorder
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
CBT Based Self-help Workbook + Counseling Telephone
Sponsored by
About this trial
This is an interventional treatment trial for Attention-Deficit/Hyperactivity Disorder focused on measuring Program Evaluation, ADHD
Eligibility Criteria
Inclusion Criteria:
- Child diagnosis of ADHD
Exclusion Criteria:
- Language or reading difficulties of participating parent
Sites / Locations
- Department of Child and Adolescent Psychiatry and Psychotherapy at the University of Cologne
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Strengths & Difficulties Questionnaire (SDQ)
Questionnaire assesses comorbid symptoms. Informant is the participating parent.
Quality of Life Questionnaire KINDL (Ravens-Sieberer & Bullinger, 2000)
Questionnaire assesses child´s quality of life. Informant is participating parent.
Full Information
NCT ID
NCT01351246
First Posted
May 2, 2011
Last Updated
April 14, 2014
Sponsor
University of Cologne
Collaborators
Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT01351246
Brief Title
Guided Self-Help for Parents of Children With Attention-Deficit/Hyperactivity Disorder (ADHD)
Official Title
Guided Self-Help for Parents of Children With Attention-Deficit/Hyperactivity Disorder (ADHD): A Feasibility and Effectiveness Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cologne
Collaborators
Eli Lilly and Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention-Deficit/Hyperactivity Disorder
Keywords
Program Evaluation, ADHD
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
CBT Based Self-help Workbook + Counseling Telephone
Other Intervention Name(s)
Guided self help, behavioral treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Total score of the Symptom Checklist Attention-Deficit/Hyperactivity Disorder (SCL-ADHD, Döpfner, Görtz-Dorten & Lehmkuhl, 2008
Description
Questionnaire assesses the diagnostic criteria of DSM-IV and ICD-10 for ADHD. Informant is participating parent.
Time Frame
one year
Secondary Outcome Measure Information:
Title
Strengths & Difficulties Questionnaire (SDQ)
Description
Questionnaire assesses comorbid symptoms. Informant is the participating parent.
Time Frame
1 year
Title
Quality of Life Questionnaire KINDL (Ravens-Sieberer & Bullinger, 2000)
Description
Questionnaire assesses child´s quality of life. Informant is participating parent.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Child diagnosis of ADHD
Exclusion Criteria:
Language or reading difficulties of participating parent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manfred Döpfner, PhD
Organizational Affiliation
University of Cologne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Child and Adolescent Psychiatry and Psychotherapy at the University of Cologne
City
Cologne
State/Province
NRW
ZIP/Postal Code
50931
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Guided Self-Help for Parents of Children With Attention-Deficit/Hyperactivity Disorder (ADHD)
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