Combining one-session treatment with a homework program including app-based technology to enhance the treatment of childhood specific phobias: A study protocol of a multicenter pragmatic randomized controlled trial

Contemporary Clinical Trials Communications, vol. 41, pp. 101346

Abstract

Introduction: Childhood specific phobias are among the most common and earliest onset mental disorders with a lifetime prevalence of more than ten percent. Brief intensive cognitive behavioral therapy (CBT) programs such as the One-Session Treatment (OST) are found to be effective in the remission of the specific phobias following treatment, but there is still room for improvement. The goal of the current study is to examine whether the long-term efficacy of OST increases by using a homework program supported by an app specifically designed for children; the Kids Beat Anxiety (KibA) homework program. Methods: Children aged between 7 and 14 years with a specific phobia receive OST preceded by a three-week baseline phase to control for time-effects. Directly following OST, children are randomized to either a four-week homework period supported by an app (OST + app), or standard One-Session Treatment with a four-week homework period that is only supported by therapist instructions (OST-only). Primary outcome variables are diagnosis and severity of the specific phobia. Secondary outcomes include behavioral avoidance, self-reported fear, and functional impairment. Data will be analyzed based on intention-to-treat and per protocol samples using mixed-effects multilevel linear models. Ethics and dissemination: The current study was approved by the METC of the Academic Medical Center, Amsterdam, The Netherlands (number: NL72697.018.20) and the Ethical Committee of the Ruhr University, Bochum, Germany (number: 663). Results of this trial will be published in peer-reviewed journals. Trial registration: The study was pre-registered at the Dutch Trial Register, number: NL 9216.

Authors 15

1. Anke M. Klein corresponding Aachen Developmental and Educational Psychology

   Leiden University

   Affiliation as printed

   Developmental and Educational Psychology, Leiden University, the Netherlands

2. Jasmin Rahemenia Aachen Developmental and Educational Psychology

   Leiden University

   Affiliation as printed

   Developmental and Educational Psychology, Leiden University, the Netherlands

3. Erwin de Gier
   Affiliation as printed

   Trifork Amsterdam B.V., the Netherlands

4. Ronald M. Rapee

   Macquarie University

   Affiliation as printed

   Centre for Emotional Health, Macquarie University, Australia

5. Maaike H. Nauta

   University of Groningen · Accare

   Affiliation as printed

   Accare Child Study Center, Groningen, the Netherlands

   Faculty of Behavioral and Social Sciences, University of Groningen, the Netherlands

6. Esther De Bruin

   University of Amsterdam

   Affiliation as printed

   Research Institute of Child Development and Education, University of Amsterdam, the Netherlands

   UvA Minds, Amsterdam, the Netherlands

7. Julia Biesters

   University of Amsterdam

   Affiliation as printed

   UvA Minds, Amsterdam, the Netherlands

8. Lukas van Rijswijk

   University of Amsterdam

   Affiliation as printed

   UvA Minds, Amsterdam, the Netherlands

9. Anika Bexkens Aachen Developmental and Educational Psychology

   Leiden University

   Affiliation as printed

   Developmental and Educational Psychology, Leiden University, the Netherlands

10. Jeanine M. D. Baartmans Aachen Education and Child Studies

    Leiden University

    Affiliation as printed

    Education and Child Studies, Leiden University, the Netherlands

11. Lynn Mobach

    University of Amsterdam

    Affiliation as printed

    Developmental Psychology, University of Amsterdam, the Netherlands

12. R. Zimmermann

    Ruhr University Bochum

    Affiliation as printed

    Mental Health Research and Treatment Center (FBZ), Ruhr University Bochum, Germany

13. Susan Maria Bögels

    University of Amsterdam

    Affiliation as printed

    Developmental Psychology, University of Amsterdam, the Netherlands

14. Thomas H. Ollendick

    Virginia Tech

    Affiliation as printed

    Child Study Center, Department of Psychology, Virginia Tech, USA

15. Silvia Schneider

    Deutsches Zentrum für Psychische Gesundheit · Ruhr University Bochum

    Affiliation as printed

    German Center for Mental Health (DZPG), Germany

    Mental Health Research and Treatment Center (FBZ), Ruhr University Bochum, Germany