CClinicalTrials.gg
Status unknownNCT01350986FLOHUpdated May 10, 2011

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

An interventional study of Cognitive-Behavioral Self-help Workbook + Counseling Telephone Calls and Non-Directive Self-Help Workbook + Counseling Telephone Calls in Oppositional Defiant Disorder, Attention Deficit Hyperactivity Disorders and Attention Deficit and Disruptive Behavior Disorders, sponsored by German Research Foundation. Status unknown at 1 site in Germany. Open to participants aged 4 Years to 11 Years. Per ClinicalTrials.gov, last updated 2011-05-10.

Sponsored by German Research Foundation · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2011), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
146
Allocation
Randomized
Ages
4 Years to 11 Years
Sex
All
01

Study 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.

02

Conditions studied

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

Keywords

  • Controlled Clinical Trials, Randomized
03

In context

Attention Deficit Disorder with Hyperactivity

1,514 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 255 are open to participants now.

This study's planned enrollment of 146 is above the median of 72 across 1,207 interventional studies indexed under Attention Deficit Disorder with Hyperactivity.

Browse Attention Deficit Disorder with Hyperactivity studies →

Lead sponsor

German Research Foundation is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 11 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
146 participants (estimated)

Study arms

  • Experimental
    Directive

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

  • Active comparator
    Non-Directive

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

Interventions

  • BehavioralCognitive-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).

    Also known as: FLOH

  • BehavioralNon-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).

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: pre, intermediate, post, 6-month FU, 12-month FU

  2. 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.

    Time frame: pre, intermediate, post, 6-month FU, 12-month FU

  3. 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.

    Time frame: pre, intermediate, post, 6-month FU, 12-month FU

  4. 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.

    Time frame: pre, intermediate, post, 6-month FU, 12-month FU

07

Study locations

1 of 1 sites recruiting
  • Department of Child and Adolescent Psychiatry and Psychotherapy at the University of Cologne
    Cologne, NRW 50931, Germany
    Recruiting
08

References and documents

Publications

  • 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. PubMed 36064990 ↗
  • 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. PubMed 34560813 ↗
  • 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. PubMed 32322227 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 10, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01350986
Lead sponsor
German Research Foundation
First posted
May 10, 2011
Start date
May 2011
Primary completion
Mar 2013 (estimated)
Completion
Mar 2013 (estimated)
Last update
May 10, 2011

Study contacts

Manfred Döpfner, PhD
Contact
manfred.doepfner@uk-koeln.de
+49 221 4786105
Christopher Hautmann, PhD
Contact
christopher.hautmann@googlemail.com
+49 177 641 65 44
Manfred Döpfner, PhD
principal investigator · University of Cologne

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2011. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion