Guided Self-Help for Parents of Children With Externalizing Problem Behavior (FLOH)

May 9, 2011 updated by: German Research Foundation

Efficacy of Cognitive-Behavioral Based Guided Self-Help for Parents of Children With Externalizing Problem Behavior

The efficacy of cognitive-behavioral based guided self-help for parents of children with externalizing problem behavior is tested in a randomized clinical trial. Parents work through cognitive-behavioral self-help booklets and additionally receive counseling telephone calls every two weeks. In the control condition parents are provided non-directive self-help booklets and additionally receive counseling telephone calls. It is hypothesized that the cognitive-behavioral treatment is superior.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

146

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
    • NRW
      • Cologne, NRW, Germany, 50931
        • Recruiting
        • Department of Child and Adolescent Psychiatry and Psychotherapy at the University of Cologne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 11 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Child diagnosis of ODD and/or ADHD based on DCL-ODD and DCL-ADHD respectively

Exclusion Criteria:

  • Child IQ is below 80
  • Child has diagnosis of pervasive developmental disorder (PDD)
  • Indication for inpatient/intensive treatment for child
  • Parent training while intervention period
  • Planed start, change or discontinuation of psychopharmacological treatment for child while intervention period
  • No parental adherence or willingness for randomisation process
  • Language or reading difficulties of participating parent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Directive
Behavioral: Cognitive-Behavioral Self-help Workbook + Counseling Telephone Calls
In intervention period of 5 months parents work through 8 cognitive-behavioral self-help booklets (FLOH) and additionally receive 10 counseling telephone calls. Primary purpose of telephone calls is to clarify content of the booklets and support parents in managing their homework assignments accompanied with each booklet. 3 and 6 months after intervention period has ended, two additional booster telephone calls are provided. The booklets are based on the therapy manual "Treatment 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).
Other Names:
  • FLOH
ACTIVE_COMPARATOR: Non-Directive
Behavioral: Non-Directive Self-Help Workbook + Counseling Telephone Calls
In intervention period of 5 months parents are provided 8 non-directive self-help booklets and additionally receive 10 non-directive counseling telephone calls. If the telephone calls are used to clarify content of the booklets or to discuss other child and parenting related topics is at the parents' discretion. Main focus for counselor is to be congruent, empathic and to have unconditional positive regard toward the parents. 3 and 6 months after intervention period has ended, two additional booster telephone calls are provided. The booklets are based on "Parent effectiveness training" (Gordon, 1970) and "Teaching children self-discipline at home and at school" (Gordon, 1989).
Other Names:
  • "Parent effectiveness training"; "Teaching children self-discipline at home and at school"

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change Oppositional Defiant Disorder subscale score of the Symptom Checklist Disruptive Behavior Disorder (SCL-ODD; Döpfner, Görtz-Dorten, & Lehmkuhl, 2008)
Time Frame: pre, intermediate, post, 6-month FU, 12-month FU
Questionnaire considers the diagnostic criteria of DSM-IV and ICD-10 for ODD. Informant is participating parent.
pre, intermediate, post, 6-month FU, 12-month FU
Change total score of the Symptom Checklist Attention-Deficit/Hyperactivity Disorder (SCL-ADHD; Döpfner, Görtz-Dorten, & Lehmkuhl, 2008)
Time Frame: pre, intermediate, post, 6-month FU, 12-month FU
Questionnaire considers the diagnostic criteria of DSM-IV and ICD-10 for ADHD. Informant is participating parent.
pre, intermediate, post, 6-month FU, 12-month FU
Change Oppositional Defiant Disorder subscale score of the Diagnostic Checklist Disruptive Behavior Disorder (DCL-ODD; Döpfner, Görtz-Dorten, & Lehmkuhl, 2008)
Time Frame: pre, intermediate, post, 6-month FU, 12-month FU
Diagnostic interview considers the criteria of DSM-IV and ICD-10 for ODD. Informant is mental health worker.
pre, intermediate, post, 6-month FU, 12-month FU
Change total score of the Diagnostic Checklist Attention-Deficit/Hyperactivity Disorder (DCL-ADHD; Döpfner, Görtz-Dorten, & Lehmkuhl, 2008)
Time Frame: pre, intermediate, post, 6-month FU, 12-month FU
Diagnostic interview considers the criteria of DSM-IV and ICD-10 for ADHD. Informant is mental health worker.
pre, intermediate, post, 6-month FU, 12-month FU

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

German Research Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (ANTICIPATED)

March 1, 2013

Study Completion (ANTICIPATED)

March 1, 2013

Study Registration Dates

First Submitted

May 6, 2011

First Submitted That Met QC Criteria

May 9, 2011

First Posted (ESTIMATE)

May 10, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

May 10, 2011

Last Update Submitted That Met QC Criteria

May 9, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DO 620/5-1
  • Köln Fortune (OTHER_GRANT: 28/2010)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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