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

Oppositional Defiant Disorder Clinical Trial

— FLOH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01350986
• Other study ID #: DO 620/5-1
• Secondary ID: Köln Fortune
• Status: Recruiting
• Phase: N/A
• First received: May 6, 2011
• Last updated: May 9, 2011
• Start date: May 2011
• Est. completion date: March 2013

Study information

• Verified date: May 2011
• Source: German Research Foundation
• Contact: Manfred Döpfner, PhD
• Phone: +49 221 4786105
• Email: manfred.doepfner[@]uk-koeln.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Committee at the University Hospital of Cologne
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 146
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 11 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit and Disruptive Behavior Disorders
• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorders
• Disease
• Oppositional Defiant Disorder

Intervention

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).
• 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).

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
German Research Foundation

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change Oppositional Defiant Disorder subscale score of the Symptom Checklist Disruptive Behavior Disorder (SCL-ODD; Döpfner, Görtz-Dorten, & Lehmkuhl, 2008)	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	No
Primary	Change total score of the Symptom Checklist Attention-Deficit/Hyperactivity Disorder (SCL-ADHD; Döpfner, Görtz-Dorten, & Lehmkuhl, 2008)	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	No
Primary	Change Oppositional Defiant Disorder subscale score of the Diagnostic Checklist Disruptive Behavior Disorder (DCL-ODD; Döpfner, Görtz-Dorten, & Lehmkuhl, 2008)	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	No
Primary	Change total score of the Diagnostic Checklist Attention-Deficit/Hyperactivity Disorder (DCL-ADHD; Döpfner, Görtz-Dorten, & Lehmkuhl, 2008)	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	No