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

Study Overview
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Brief Summary
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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.

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

Conditions
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Oppositional Defiant Disorder, Attention Deficit Hyperactivity Disorders, Attention Deficit and Disruptive Behavior Disorders

Intervention / Treatment
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* Behavioral: Cognitive-Behavioral Self-help Workbook + Counseling Telephone Calls
* Behavioral: Non-Directive Self-Help Workbook + Counseling Telephone Calls


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Directive<br> | Behavioral: Cognitive-Behavioral Self-help Workbook + Counseling Telephone Calls<br>* 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).<br>* Other names: FLOH;|
| Active Comparator: Non-Directive<br> | Behavioral: Non-Directive Self-Help Workbook + Counseling Telephone Calls<br>* 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).<br>* Other names: Parent effectiveness training; Teaching children self-discipline at home and at school;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Controlled Clinical Trials, Randomized