Clinical trial NCT01350986: Guided Self-Help for Parents of Children With Externalizing Problem Behavior
Official title: Efficacy of Cognitive-Behavioral Based Guided Self-Help for Parents of Children With Externalizing Problem Behavior
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Oppositional Defiant Disorder
Attention Deficit Hyperactivity Disorders
Attention Deficit and Disruptive Behavior Disorders
Keywords: Controlled Clinical Trials, Randomized
Lead sponsor: German Research Foundation
Sponsor class: OTHER
First posted: 2011-05-10
Enrollment: 146
Sex: ALL
Minimum age (years): 4
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change Oppositional Defiant Disorder subscale score of the Symptom Checklist Disruptive Behavior Disorder (SCL-ODD; Döpfner, Görtz-Dorten, & Lehmkuhl, 2008)
timeFrame: pre, intermediate, post, 6-month FU, 12-month FU
measure: Change total score of the Symptom Checklist Attention-Deficit/Hyperactivity Disorder (SCL-ADHD; Döpfner, Görtz-Dorten, & Lehmkuhl, 2008)
timeFrame: pre, intermediate, post, 6-month FU, 12-month FU
measure: Change Oppositional Defiant Disorder subscale score of the Diagnostic Checklist Disruptive Behavior Disorder (DCL-ODD; Döpfner, Görtz-Dorten, & Lehmkuhl, 2008)
timeFrame: pre, intermediate, post, 6-month FU, 12-month FU
measure: Change total score of the Diagnostic Checklist Attention-Deficit/Hyperactivity Disorder (DCL-ADHD; Döpfner, Görtz-Dorten, & Lehmkuhl, 2008)
timeFrame: pre, intermediate, post, 6-month FU, 12-month FU
Secondary outcomes:
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: Department of Child and Adolescent Psychiatry and Psychotherapy at the University of Cologne
state: NRW
Study officials:
affiliation: University of Cologne
name: Manfred Döpfner, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.