3-year Follow-up of the Mind My Mind RCT
Condition: Emotional Problem; Anxiety Disorder of Childhood; Depressive Symptoms; Behavior Problem of Childhood and Adolescence; Mental Health Disorder
MeSH terms: Anxiety Disorders; Depression; Problem Behavior; Mental Disorders
Study type: Observational

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.
    

Detailed description: 
      Background: Behavioral and cognitive-behavioral therapy (CBT) programs targeting a single
      class of problems are effective, however, these interventions have not been widely
      implemented, and the population of youth with common mental health problems is markedly
      undertreated. This knowledge-practice gap calls for pragmatic trials testing the long-term
      effectiveness of scalable interventions for common mental health problems among youth.

      Objective: 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 RCT (Clinical Trials Identifier: NCT03535805) evaluated a scalable, transdiagnostic
      intervention for help-seeking youth with emotional and behavioral health problems below the
      threshold for referral to specialized mental health services.

      The specific aim of this follow-up study is to determine the long-term effects of the
      transdiagnostic and modular CBT program ("Mind My Mind" [MMM]) compared to management as
      usual (MAU). The secondary aim is to conduct a cost-effectiveness analysis of MMM versus MAU.

      Design: This long-term follow-up of the MMM versus MAU is nested in a larger observational
      study of the population of help-seeking youths who were screened for eligibility. We used a
      stage-based approach to identify youths with mental health problems requiring an intervention
      and to stratify the youths into three groups with increasing severity of problems. The youth
      with an intermediate level of emotional and behavioral problems were included in the RCT. The
      long-term outcome of the two comparison groups in the RCT will be investigated by
      administration of research questionnaires to the parents, and the total study population will
      be described by use of register-based data. The combined use of questionnaires and
      register-based data will minimize problems of attrition.

      Setting: Non-specialist school-based settings in four municipalities in Denmark.

      Participants: In summary, 573 help-seeking youths (age 6-16 years) and their parents took
      part in the screening. Seventy-five (13%) had mental health problems below the intervention
      threshold, 396 (69%) were deemed eligible for the early intervention and included in the RCT,
      and 52 (9%) had symptoms of severe mental health problems and disorders and were referred to
      specialized services. Fifty (9%) youth were excluded for other reasons. A total of 396 youths
      were identified with anxiety, depressive symptoms, and/or behavioral disturbances. This group
      was included in the RCT and randomized to MMM (n=197) or MAU (n=199). The primary outcome was
      the impact of mental health problems reported by the parent at week 18, using the Strengths
      and Difficulties Questionnaire (SDQ) impact scale (range=0-10 points).

      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.

      Interventions: The follow-up study does not include an intervention. The MMM consisted of
      9-13 weekly, individual therapy sessions delivered by local psychologists who received
      education and weekly supervision in the MMM manual. The CBT methods were organized in modules
      for anxiety, depression and behavioral problems. Flowcharts described the sequencing and
      dosing of modules to match the problems at hand, e.g. parent management training for youth's
      behavioral problems. The therapy was completed within 17 weeks, followed by a booster session
      after four weeks.

      The MAU was enhanced by two care-coordination visits (week 2 and 17) to help access care in
      the municipality. The MAU interventions included anonymous counseling, pedagogical advice,
      network meetings, educational support, private or publicly funded psychological treatment, or
      no treatment.

      Outcomes: 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 by linking of
      individual-level data from several registries. The follow-up will be conducted approximately
      three years (30-43 months) after the random allocation to intervention in the RCT.

      The register-based exploratory outcomes will focus on the youth's use of psychiatric and
      somatic health care services, academic performance on the national school tests and exams,
      school absence and wellbeing in school. Regarding use of health care services, we will study
      the time to the first contact, and the frequency and the pattern of contacts
      (acute/non-acute, inpatient/outpatient, psychiatric/somatic) during the follow-up period. We
      will also track activities in the social sector including notifications to the authorities
      stating a concern for the health and wellbeing of the young person, and preventative
      interventions to assist the family. Finally, we will study changes in the parents' employment
      status (including sick leave, part-time work and unemployment) during the follow-up period to
      assess whether the participation in MMM, relatively to MAU, did influence the life
      circumstances of the family in a broader sense.

      Cost-effectiveness analysis: The evaluation of the cost-effectiveness of the MMM, relative to
      MAU, will build on our previous cost-utility analysis (CUA) of data from the RCT. The
      extended follow-up time will reduce the uncertainty around the results by replacing the
      extrapolation scenarios with repeated assessment of the health-related quality of life
      measured with the parent-reported questionnaire CHU9D. The analyses of costs will include
      register-based, individual-level data on the young person's health care utilization in the
      3-year follow-up period from the date of randomization, along with the associated unit costs
      that are listed in administrative registers.

      Perspectives: The study will provide new knowledge of the long-term effectiveness of
      transdiagnostic CBT to lower the burden of mental health disorders in youth.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study subjects are the 396 school-aged youths who were identified with indicated need
        for treatment of anxiety, depressive symptoms, and/or behavioral disturbances and
        randomized to MMM (n=197) or MAU (n=199).

        The parent of each of subject will be invited to answer questionnaires to assess the
        long-term outcomes.

        We will also follow the help-seeking population (n=573) and the age-matched background
        population in the four municipalities (study sites) by use of data drawn from the Danish
        National Registries (reference groups).
      
Keywords: Cognitive Behavioral Therapy; Long-term follow-up of RCT; Effectiveness; Transdiagnostic; Children; Adolescents; Youths; Indicated prevention; Personalized treatment