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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 4 to 11 years
• All sexes
• No healthy volunteers
• Child

Trial locations and contacts

1 site in 1 country.

About this study

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

Conditions

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

Being tested

Cognitive-Behavioral Self-help Workbook + Counseling Telephone Calls, Non-Directive Self-Help Workbook + Counseling Telephone Calls

Keywords

Controlled Clinical Trials, Randomized

Medical subject headings

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

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Cognitive-Behavioral Self-help Workbook + Counseling Telephone CallsBehavioural

  Also called FLOH

  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).

• Non-Directive Self-Help Workbook + Counseling Telephone CallsBehavioural

  Also called "Parent effectiveness training"; "Teaching children self-discipline at home and at school"

  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).

What is being measured

The primary outcome is the main question the study is designed to answer.

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.

   Measured: 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.

   Measured: 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.

   Measured: 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.

   Measured: pre, intermediate, post, 6-month FU, 12-month FU

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted10 May 2011 (estimated)
2. Study startMay 2011
3. Primary completionMar 2013 (estimated)
4. Study completionMar 2013 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Publications (4)Papers the sponsor has linked to this study.
• Other trials for Oppositional Defiant DisorderStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.