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3-year Follow-up of the Mind My Mind RCT

NCT04804917 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 396

Last updated 2023-03-23

No results posted yet for this study

Summary

This is a three-year follow up of a previously completed randomized clinical trial (RCT) of a transdiagnostic cognitive and behavioral (CBT) program ("Mind My Mind" \[MMM\]) compared to management as usual (MAU) in youth with emotional and behavioral problems.

The effectiveness trial (Clinical Trials Identifier: NCT03535805) evaluated an intervention for help-seeking youth with emotional and behavioral health problems below the threshold for referral to specialized treatment. The experimental intervention MMM consisted of 9-13 weekly, individual therapy sessions delivered by psychologists in a non-specialist school-based setting. The CBT-methods were organized in modules for anxiety, depression and/or behavioral problems, and the therapy was completed within 17 weeks. The MAU was enhanced by two care-coordination visits to help coordinate the usual care in the four municipalities in Denmark. The trial was conducted in four diverse municipalities in Denmark.

The aim of this study is to determine the long-term effects of the transdiagnostic, modular CBT program ("Mind My Mind" \[MMM\]) compared to management as usual (MAU).

The three-year follow-up of the RCT of MMM versus MAU is nested in a larger study of help-seeking youth screened for eligibility and stratified into three groups with increasing severity of problems. Youths with an intermediate level of problems were included in the RCT. We screened 573 help-seeking youths, and we included and randomized a total of 396 youths (age 6-16 years, with anxiety, depressive symptoms, and/or behavioral problems) to MMM (n=197) or MAU (n=199).

The study participants comprise the 396 youths and their parents who participated in the RCT. We will use the help-seeking population and the background population in the four municipalities as reference groups.

The follow-up study does not include an intervention. The long-term outcome of MMM versus MAU will be investigated using parent-reported questionnaires administered in average three years after random allocation to intervention. All study participants are followed in the Danish national registries.

Conditions

  • Emotional Problem
  • Anxiety Disorder of Childhood
  • Depressive Symptoms
  • Behavior Problem of Childhood and Adolescence
  • Mental Health Disorder

Sponsors & Collaborators

  • Frederiksberg University Hospital

    collaborator OTHER

  • Defactum, Central Denmark Region

    collaborator OTHER_GOV

  • The Danish Mental Health Foundation

    collaborator OTHER

  • Mental Health Services in the Capital Region, Denmark

    lead OTHER

Principal Investigators

  • Pia Jeppesen, PhD · Mental Health Services in the Capital Region, Denmark

Eligibility

Min Age
8 Years
Max Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-22
Primary Completion
2021-08-31
Completion
2021-09-17

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04804917 on ClinicalTrials.gov