Transdiagnostic, Cognitive and Behavioral Intervention for in School-aged Children With Emotional and Behavioral Disturbances
Condition: Anxiety; Anxiety Disorders; Depressive Symptoms; Depressive Disorders; Problem Behavior; Oppositional Defiant Disorder; Conduct Disorder; Other Behavioral and Emotional Disorders With Onset Usually Occurring in Childhood and Adolescence
MeSH terms: Anxiety Disorders; Depressive Disorder; Depression; Conduct Disorder; Problem Behavior; Attention Deficit and Disruptive Behavior Disorders
Study type: Interventional

Summary: 
      Background

      Impairing emotional and behavioural problems are common in children and adolescents and mark
      a three-fold increased risk of mental disorder in young adulthood. Evidence-based
      psychological interventions are recommended for indicated prevention and first-line
      treatment, but access to treatment is often limited.

      A new, modular cognitive and behavioural therapy program Mind My Mind (MMM) comprising
      evidence-based interventions for children with emotional and behavioral problems was designed
      to be delivered by educational psychologists in the Danish municipalities.

      A feasibility RCT (NCT03448809), demonstrated that the study design was acceptable among
      children, parents, and therapists, and it provided data to estimate the sample size needed
      for the definitive RCT. The investigators test the hypothesis that the parent-reported impact
      of mental health problems will be significantly lower for children in the MMM group as
      compared with children in the TAU group after the 18-week intervention period (primary
      hypothesis), and after follow-up at week 26 (first secondary hypothesis).

      Aim

      To investigate the effects and cost-effectiveness of MMM compared with TAU for children and
      adolescents with impairing anxiety, depressive symptoms and/or behavioral problems. Both
      beneficial and harmful effects are evaluated.

      Methods

      The study compares the new modular MMM with TAU for children aged 6-16 years with anxiety,
      depressive symptoms or behavioral problems impacting on their daily and social life. The
      trial is conducted in four Danish municipalities in the period from September 2017 to April
      2019. Participants are children with indicated needs.

      The parents sign up the child for assessment in the Pedagogical Psychological Services in the
      Municipalities. The assessment includes web-based standardized questionnaires for child and
      parent: 1) the strengths and difficulties questionnaire (SDQ), 2) Spence Children's Anxiety
      Scale, 3) Mood and Feelings Questionnaire, and 4) family, social and school functioning. The
      questionnaires are supplemented with a clinical psychopathological interview by a trained
      psychologist. The investigators exclude children with 1) low levels of problems and no
      indicated needs, or 2) high levels of problems and need of referral to the Child and
      Adolescent Psychiatry.

      412 children will be included and randomized (1:1) to MMM versus TAU. MMM is supported by a
      central organization, who is responsible for the education and weekly supervision of the
      therapists, and the web-based data collection and feedback of data in real time to therapists
      and researchers. All outcomes are self-, parent- and teacher-reported scores on standardized
      questionnaires administered at baseline, week 18 and week 26. At entry, the child and the
      parents own description of the Top-problem is recorded and scored on a 10-point likert scale.
      The Top-problem and impact of problem is scored by parent and child every second week during
      the intervention period, and the progress is monitored by the therapists in the MMM group.
      Information on costs is gathered through administrative registers and questionnaires at
      baseline, week 18, and week 26.

      Primary objectives and outcome measures

      This primary outcome is measured with the parent-reported SDQ impact-scale. The minimum
      relevant difference in impact of mental health problems was set at 1.0 corresponding to a
      change from severe to moderate, or from moderate to little-or-no impact in one of five
      domains of child's life: distress, home-life, friendships, classroom learning and leisure
      activities.

      Secondary objectives and outcomes measures

      The key secondary hypotheses are that the children in the MMM group will show significantly
      lower levels of parent-reported anxiety, depressive symptoms, functional impairment,
      Top-problems and behavioural problems, and better school attendance and quality-of-life as
      compared with the children in the TAU group at week 18.

      All other outcomes are explored at week 18 and 26, including the primary and secondary
      measures of potential harm: 1) youths with severe and increased levels of self-reported
      suicidality, hopelessness and/or negative self-evaluation, and 2) youths with poor quality of
      life in relation to family, free time and friends.

      Statistical analyses

      All analyses will be intention-to-treat with two-sided significance tests. The investigators
      will use mixed models with repeated measures for continuous outcomes and generalized linear
      mixed model for binary and non-normally distributed outcomes. For the key secondary outcomes,
      the investigators will use the strategy of hierarchical testing allowing us to preserve the
      level of significance, α=0.05, as long as the null hypotheses are rejected. The incremental
      cost-effectiveness ratio will be calculated to analyze cost-effectiveness.

      Perspectives

      The results will guide policy makers in deciding whether to implement modular CBT-programs
      like the MMM.
    


Intervention name(s): Mind My Mind (MMM); Treatment as Usual (TAU)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Mind My Mind (MMM) is a new transdiagnostic and modular cognitive and behavioural therapy (CBT) program comprising evidence-based interventions for children and adolescents with anxiety, depression or disruptive behavior.
MMM manual consists of evidence-based CBT methods that are organized into modules. The intervention is tailored to the individual child by the dosing and the sequencing of the modules. Trauma-focused CBT is available. Parents are engaged in child's therapy and support the child in doing the homework. Parent management training is offered for behavioral disturbances. The educational psychologists deliver the therapy after one-week training in the manual, followed by weekly supervision. The treatment fidelity is monitored by video observation of therapy sessions (>20%).
The MMM training program consists of 9-13 sessions plus one booster, all completed within 17 weeks.; The parents in the TAU group are offered two sessions (week 2 and week 17) to support their attempts to seek help for the child in the municipality. This coordination is provided by psychologists (or other local professionals) who hold records of the currently available treatment options in the municipality. The TAU vary considerably from no intervention to counselling, talk therapy, pedagogical advice, network meetings, and/or individual support in the school setting. Some children are offered CBT interventions, but access to manualized treatment is generally very limited.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The RCT is a parallel, two-arm, superiority trial comparing MMM with TAU for children aged 6-16 years with emotional and behavioural difficulties.
This primary outcome is the parent-reported SDQ-impact of problems (range 0-10). The sample size calculation was based on the parameters from the feasibility RCT. Given an estimated standard variation (SD)=2.7, significance level=0.05, and power=0.90, the sample required to detect (or reject) a difference of at least 1.0 point is N=308. This sample size is also sufficient to detect clinically meaningful group differences in secondary outcome (e.g. 7.5% versus 16% reporting harm).
The expected rate of attrition is 0.25. Hence, the investigators need to include 308/0.75=412 children to be randomly allocated (1:1). The central randomization uses concealed allocation sequences with variable block size, and stratification by region, age (6-10 or 11-16 years) and Top-problem (anxiety, depression, behavioural problems).
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cognitive and Behavioral Therapies; Children and Adolescents; Community Health Care; Early Intervention