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The Capital Region of Denmark - a part of Copenhagen University Hospital

The Mind My Mind study: Randomized trial of a transdiagnostic, cognitive and behavioral intervention versus treatment as usual in school-aged children with emotional and behavioral disturbances

Project: Types of projectsProject

  • Jeppesen, Pia (Project Manager, academic)
  • Wolf, Rasmus Trap (Project participant)
  • Vassard, Ditte (Project participant)
  • Pagsberg, Anne Katrine (Working partner)
  • Bilenberg, Niels, Department for Child and Adolescent Psychiatry, Mental Health Services in the Region of Southern Denmark, Odense, Denmark. Institute of Clinical Medicine, University of Southern Denmark, Odense, Denmark, Denmark (Working partner)
  • Thomsen, Per Hove, Research Center at the Department for Child- and Adolescent Psychiatry, Aarhus University Hospital, Skejby, Denmark. Institute of Clinical Medicine, Aarhus University, Aarhus, Denmark, Denmark (Working partner)
  • Thastum, Mikael, Centre for the Psychological Treatment of Children and Adolescents, Department of Psychology and Behavioural Sciences, Aarhus BSS, Aarhus University, Aarhus, Denmark, Denmark (Working partner)
  • Plessen, Kerstin Jessica, Division of Child and Adolescent Psychiatry, Department of Psychiatry, Lausanne University Hospital CHUV, Lausanne, Switzerland, Switzerland (Working partner)
  • Neumer, Simon-Peter, Centre for Child and Adolescent Mental Health, Oslo, Norway; The Arctic University of Norway, Centre for Child and Youth Mental Health and Child Welfare, North Norway (RKBU North), Tromsø, Norway., Norway (Working partner)
  • Silverman, Wendy K., Anxiety and Mood Disorders Program, Yale Child Study Center, Yale University School of Medicine, New Haven, Connecticut, United States, United States (Project participant)
  • Correll, Christoph U. , Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Department of Psychiatry and Molecular Medicine, Hempstead, New York, United States; The Zucker Hillside Hospital, Department of Psychiatry, Glen Oaks, New York, United States; Feinstein Institute for Medical Research, Center for Psychiatric Neuroscience, Manhasset, New York, United States; Charité Universitätsmedizin, Department of Child and Adolescent Psychiatry, Berlin, Germany., United States (Project participant)
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Intro:
Anxieties, depressive symptoms and behavioral problems are the most common mental health problems in the general population of school-aged children, and the symptoms often fluctuate or persist with long term negative consequences. The rationale for this development and evaluation of a new transdiagnostic and modular treatment program is the need for large-scale implementation of evidence-based psychological interventions for the heterogenous group of youths in need of care in non-specialist settings.

Methods:
We developed and evaluated the program in a pragmatic, open-label, analysts-masked, parallel, two-arm, randomized superiority trial of a transdiagnostic and modular CBT program (Mind My Mind [MMM]) compared to management as usual (MAU) for help-seeking youth of age 6-16 years. Finally, we conducted a cost-effectiveness study focusing on the challenges of measuring quality-adjusted life years (QALYs) in the youth population. The transdiagnostic approach made it possible to “transfer” evidence-based cognitive-behavioral therapies (CBT) from single-disorder programs for anxiety, depression and behavioral problems into one manualized program that could be implemented in non-specialist settings. The transdiagnostic approach is a promising way to disseminate prevention and early intervention programs for common problems.

Results/discussion/impact (expected):
The results of the RCT (n=396 randomized 1:1) showed superiority of MMM compared to MAU regarding change in parent-reported impact of problems, and the secondary and explorative outcomes confirmed the beneficial effects of MMM versus MAU regarding change in levels of anxieties, depressive symptoms, daily and social functioning, school attendance, top-problem scores, experience with services, and parental stress. Also, harms were lower with MMM. We also evaluated our novel approach to stage-based identification and stratification of the help-seeking population of youths in the municipalities.

In the ongoing 3-year follow-up study we will explore the outcomes of the three groups that were identified during the visitation process: A group with scores above threshold (n=52), a middle group with scores compatible with undergoing MMM (n=396, randomized 1:1 to MMM or treatment as usual), and a group with scores below threshold (n=75). In addition to the three visitation groups, we will also study families with at least one child aged 6-16 years in the four participating municipalities as a potential comparison group (the background population). The total study population is already linked to data drawn from the Danish national registries at Statistics Denmark. The register-based outcomes of interest include: use of mental health services, use of psychopharmaceutic drugs, school absence, school performance in exams and national tests (primarily Danish and math), out of home placements of children, notices to the municipality regarding the well-being of the child, current schooling, special education. Finally, the long-term outcomes of the randomized groups (MMM versus MAU) will be further explored. We will use online parent-reported questionnaires administered in five waves from February to August 2021, i.e. 30-42 months after random allocation to treatment.
StatusCurrent
Period20/06/201731/12/2022

ID: 61846427