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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by German Research Foundation.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
German Research Foundation
ClinicalTrials.gov Identifier:
NCT01350986
First received: May 6, 2011
Last updated: May 9, 2011
Last verified: May 2011
  Purpose

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.


Condition Intervention
Oppositional Defiant Disorder
Attention Deficit Hyperactivity Disorders
Attention Deficit and Disruptive Behavior Disorders
Behavioral: Cognitive-Behavioral Self-help Workbook + Counseling Telephone Calls
Behavioral: Non-Directive Self-Help Workbook + Counseling Telephone Calls

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Efficacy of Cognitive-Behavioral Based Guided Self-Help for Parents of Children With Externalizing Problem Behavior

Resource links provided by NLM:


Further study details as provided by German Research Foundation:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Questionnaire considers the diagnostic criteria of DSM-IV and ICD-10 for ODD. Informant is participating parent.

  • 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 ] [ Designated as safety issue: No ]
    Questionnaire considers the diagnostic criteria of DSM-IV and ICD-10 for ADHD. Informant is participating parent.

  • 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 ] [ Designated as safety issue: No ]
    Diagnostic interview considers the criteria of DSM-IV and ICD-10 for ODD. Informant is mental health worker.

  • 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 ] [ Designated as safety issue: No ]
    Diagnostic interview considers the criteria of DSM-IV and ICD-10 for ADHD. Informant is mental health worker.


Estimated Enrollment: 146
Study Start Date: May 2011
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: "Parent effectiveness training"; "Teaching children self-discipline at home and at school"

  Eligibility

Ages Eligible for Study:   4 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01350986

Contacts
Contact: Manfred Döpfner, PhD +49 221 4786105 manfred.doepfner@uk-koeln.de
Contact: Christopher Hautmann, PhD +49 177 641 65 44 christopher.hautmann@googlemail.com

Locations
Germany
Department of Child and Adolescent Psychiatry and Psychotherapy at the University of Cologne Recruiting
Cologne, NRW, Germany, 50931
Sponsors and Collaborators
German Research Foundation
Investigators
Principal Investigator: Manfred Döpfner, PhD University of Cologne
  More Information

No publications provided

Responsible Party: Manfred Döpfner, University of Cologne
ClinicalTrials.gov Identifier: NCT01350986     History of Changes
Other Study ID Numbers: DO 620/5-1, Köln Fortune
Study First Received: May 6, 2011
Last Updated: May 9, 2011
Health Authority: Germany: Ethics Committee at the University Hospital of Cologne

Keywords provided by German Research Foundation:
Controlled Clinical Trials, Randomized

Additional relevant MeSH terms:
Mental Disorders
Attention Deficit and Disruptive Behavior Disorders
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Mental Disorders Diagnosed in Childhood
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on April 14, 2014