Guided Self-Help for Parents of Children With Externalizing Problem Behavior (FLOH)
Primary Purpose
Oppositional Defiant Disorder, Attention Deficit Hyperactivity Disorders, Attention Deficit and Disruptive Behavior Disorders
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Cognitive-Behavioral Self-help Workbook + Counseling Telephone Calls
Non-Directive Self-Help Workbook + Counseling Telephone Calls
Sponsored by
About this trial
This is an interventional treatment trial for Oppositional Defiant Disorder focused on measuring Controlled Clinical Trials, Randomized
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
Sites / Locations
- Department of Child and Adolescent Psychiatry and Psychotherapy at the University of CologneRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Directive
Non-Directive
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01350986
Brief Title
Guided Self-Help for Parents of Children With Externalizing Problem Behavior
Acronym
FLOH
Official Title
Efficacy of Cognitive-Behavioral Based Guided Self-Help for Parents of Children With Externalizing Problem Behavior
Study Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Unknown status
Study Start Date
May 2011 (undefined)
Primary Completion Date
March 2013 (Anticipated)
Study Completion Date
March 2013 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
German Research Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oppositional Defiant Disorder, Attention Deficit Hyperactivity Disorders, Attention Deficit and Disruptive Behavior Disorders
Keywords
Controlled Clinical Trials, Randomized
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
146 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Directive
Arm Type
Experimental
Arm Title
Non-Directive
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-Behavioral Self-help Workbook + Counseling Telephone Calls
Other Intervention Name(s)
FLOH
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Non-Directive Self-Help Workbook + Counseling Telephone Calls
Other Intervention Name(s)
"Parent effectiveness training"; "Teaching children self-discipline at home and at school"
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change Oppositional Defiant Disorder subscale score of the Symptom Checklist Disruptive Behavior Disorder (SCL-ODD; Döpfner, Görtz-Dorten, & Lehmkuhl, 2008)
Description
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
Title
Change total score of the Symptom Checklist Attention-Deficit/Hyperactivity Disorder (SCL-ADHD; Döpfner, Görtz-Dorten, & Lehmkuhl, 2008)
Description
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
Title
Change Oppositional Defiant Disorder subscale score of the Diagnostic Checklist Disruptive Behavior Disorder (DCL-ODD; Döpfner, Görtz-Dorten, & Lehmkuhl, 2008)
Description
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
Title
Change total score of the Diagnostic Checklist Attention-Deficit/Hyperactivity Disorder (DCL-ADHD; Döpfner, Görtz-Dorten, & Lehmkuhl, 2008)
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Manfred Döpfner, PhD
Phone
+49 221 4786105
Email
manfred.doepfner@uk-koeln.de
First Name & Middle Initial & Last Name or Official Title & Degree
Christopher Hautmann, PhD
Phone
+49 177 641 65 44
Email
christopher.hautmann@googlemail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manfred Döpfner, PhD
Organizational Affiliation
University of Cologne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Child and Adolescent Psychiatry and Psychotherapy at the University of Cologne
City
Cologne
State/Province
NRW
ZIP/Postal Code
50931
Country
Germany
Individual Site Status
Recruiting
12. IPD Sharing Statement
Citations:
PubMed Identifier
36064990
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. 2022 Sep 6:1-14. doi: 10.1007/s10578-022-01400-0. Online ahead of print.
Results Reference
derived
PubMed Identifier
34560813
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.
Results Reference
derived
PubMed Identifier
32322227
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.
Results Reference
derived
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Guided Self-Help for Parents of Children With Externalizing Problem Behavior
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