NCT01350986

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
146

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

May 6, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 10, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

May 10, 2011

Status Verified

May 1, 2011

Enrollment Period

1.8 years

First QC Date

May 6, 2011

Last Update Submit

May 9, 2011

Conditions

Keywords

Controlled Clinical Trials, Randomized

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

Directive

EXPERIMENTAL
Behavioral: Cognitive-Behavioral Self-help Workbook + Counseling Telephone Calls

Non-Directive

ACTIVE COMPARATOR
Behavioral: Non-Directive Self-Help Workbook + Counseling Telephone Calls

Interventions

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).

Also known as: FLOH
Directive

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).

Also known as: "Parent effectiveness training"; "Teaching children self-discipline at home and at school"
Non-Directive

Eligibility Criteria

Age4 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

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

RECRUITING

Related Publications (4)

  • Hautmann C, Dose C, Hellmich M, Scholz K, Katzmann J, Pinior J, Gebauer S, Nordmann L, Wolff Metternich-Kaizman T, Schurmann S, Dopfner M. Behavioural and nondirective parent training for children with externalising disorders: First steps towards personalised treatment recommendations. Behav Res Ther. 2023 Apr;163:104271. doi: 10.1016/j.brat.2023.104271. Epub 2023 Feb 1.

  • Treier AK, Hautmann C, Dose C, Nordmann L, Katzmann J, Pinior J, Scholz KK, Dopfner M. Process Mechanisms in Behavioral Versus Nondirective Guided Self-help for Parents of Children with Externalizing Behavior. Child Psychiatry Hum Dev. 2024 Apr;55(2):453-466. doi: 10.1007/s10578-022-01400-0. Epub 2022 Sep 6.

  • Treier AK, Hautmann C, Katzmann J, Nordmann L, Pinior J, Scholz KK, Dopfner M. Treatment components in behavioral versus nondirective telephone-assisted self-help interventions for parents of children with externalizing behavior problems. J Clin Psychol. 2022 May;78(5):735-746. doi: 10.1002/jclp.23255. Epub 2021 Sep 24.

  • Del Giudice T, Tervoort J, Hautmann C, Walter D, Dopfner M. Cross-Cultural Validity of the Child and Adolescent Dispositions Model in a Clinical Sample of Children With Externalizing Behavior Problems. Front Psychol. 2020 Apr 8;11:641. doi: 10.3389/fpsyg.2020.00641. eCollection 2020.

MeSH Terms

Conditions

Oppositional Defiant DisorderAttention Deficit Disorder with HyperactivityAttention Deficit and Disruptive Behavior Disorders

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental Disorders

Study Officials

  • Manfred Döpfner, PhD

    University of Cologne

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 6, 2011

First Posted

May 10, 2011

Study Start

May 1, 2011

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

May 10, 2011

Record last verified: 2011-05

Locations