NCT01351246

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

May 2, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 10, 2011

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

April 15, 2014

Status Verified

April 1, 2014

Enrollment Period

3.8 years

First QC Date

May 2, 2011

Last Update Submit

April 14, 2014

Conditions

Keywords

Program EvaluationADHD

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Strengths & Difficulties Questionnaire (SDQ)

    1 year

  • Quality of Life Questionnaire KINDL (Ravens-Sieberer & Bullinger, 2000)

    1 year

Study Arms (1)

Intervention

EXPERIMENTAL
Behavioral: CBT Based Self-help Workbook + Counseling Telephone

Interventions

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.

Also known as: Guided self help, behavioral treatment
Intervention

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Child diagnosis of ADHD

You may not qualify if:

  • Language or reading difficulties of participating parent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Child and Adolescent Psychiatry and Psychotherapy at the University of Cologne

Cologne, North Rhine-Westphalia, 50931, Germany

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Manfred Döpfner, PhD

    University of Cologne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Leading psychologist at the Department of Child and Adolescent Psychiatry

Study Record Dates

First Submitted

May 2, 2011

First Posted

May 10, 2011

Study Start

May 1, 2010

Primary Completion

February 1, 2014

Study Completion

March 1, 2014

Last Updated

April 15, 2014

Record last verified: 2014-04

Locations