Randomized Feasibility Trial of Mind My Mind
Condition: Anxiety; Anxiety Disorders; Depressive Symptoms; Depressive Disorder; Problem Behavior; Oppositional Defiant Disorder; Conduct Disorder; Behavior Disorders
MeSH terms: Anxiety Disorders; Depressive Disorder; Depression; Mental Disorders; Conduct Disorder; Problem Behavior; Attention Deficit and Disruptive Behavior Disorders
Study type: Interventional

Summary: 
      In this feasibility RCT of the modular and flexible cognitive and behavioural therapy (Mind
      My Mind, MMM) compared with treatment as usual, the overall research aim was to explore the
      trial design and the acceptability of the assessments, interventions and outcome measures
      among children, parents, teachers and therapists, and secondly to provide data to estimate
      the parameters required to design a definitive RCT.
    

Detailed description: 
      Background and aims:

      Emotional and behavioral disorders are common in youths, and large-scale implementation of
      evidence-based treatments lack behind the needs of the population. The Mind My Mind (MMM)
      study in Denmark is a multidisciplinary collaborative effort to adapt current evidence-based
      treatment strategies for implementation with school children in diverse municipalities in
      Denmark. The overarching goals of the Mind My Mind study are to develop, implement, evaluate
      and disseminate a program for the prevention and treatment of children's emotional and
      behavioral disturbances at the lowest effective level.

      Methods:

      A parallel, two-arm trial compared the modular and flexible cognitive and behavioral therapy
      (Mind My Mind, MMM) with treatment as usual (TAU) for children aged 6-16 years with
      subclinical or clinical levels of emotional and behavioral difficulties.

      The trial was conducted in diverse municipalities in Denmark in the period from December 2015
      to March 2017. Participants were help-seeking school-children with indicated needs for
      psychological help. The help-seeking children entered a two-stage screening for eligibility
      by web-based standardized psychometric instruments: 1) the strengths and difficulties
      questionnaire (SDQ), 2) the Child Behaviour Checklist (CBCL) and the Youth Self-Report (YSR).
      This screening procedure was set up as a new routine in the Pedagogical Psychological
      Services (PPR) in the Municipalities. The screening enabled PPR to identify children with
      anxiety, depressive symptoms and/or behavioral problems causing distress/impact in their
      daily life (eligible for the study) versus those with too mild problems (excluded based on
      SDQ-parent-scores below a pre-specified cut-off according to an algorithm) or too severe
      problems (excluded and referred to the Child and Adolescent Psychiatry or other specialized
      services). If the child was eligible, both parents were asked to give informed consent to
      inclusion of the child in the research study.

      The included children were randomized (3:1) to MMM versus TAU. All outcomes were measured by
      use of self-, parent-, and teacher-reported questionnaires covering specific and general
      psychopathology, daily and social functioning, quality of life of the child, and parental
      distress at baseline, week 14 and week 22. At entry, the child and the parent formulated each
      three problems that they wanted to change. The Top-3-problems were written into the web-based
      questionnaire using their own words. Then, each problem was scored on a 10-point likert scale
      along with scoring of the Brief Problem Monitor (BPM) by the child and the parent separately.
      These scores were collected weekly during the treatment period, at end of treatment (week 14)
      and at follow-up (week 22). The satisfaction with the MMM sessions was also scored weekly
      (MMM arm only).

      The primary objectives and outcomes measures:

        1. To assess the flow of participants through the visitation

        2. To explore whether the visitation procedures, and the inclusion and exclusion criteria
           were applicable and appropriate for the recruitment. The included and the excluded
           children were described and compared with regard to the family and social
           characteristics, and the type and severity of psychopathology as measured with the SDQ,
           CBCL and YSR.

        3. To assess the retention of children in the MMM arm.

        4. To assess the proportion of children in the MMM arm who were referred to more
           specialized services during the study period.

        5. To assess the satisfaction with MMM sessions among children and parents in the MMM arm.

        6. To describe the dosing and sequencing of the MMM modules as reported by the therapists
           after each session and compare the actual use of the MMM manual with the intended use
           according to the manual.

      The secondary objectives and outcomes measures:

        1. To measure the key outcome domains with regard to completion rates, missing data, and
           the estimated differences between MMM and TAU.

        2. To perform an initial validation of the Top-3-problem-scores by studying the
           correlations between the scores within and across informants, across time, and the
           correlations between the Top-3-problem-scores and the BPM-scores.

      Statistical analyses:

      The feasibility measures were summarized using standard descriptive statistics. The group
      differences in outcome were analyzed in intention-to-treat (ITT) analyses using mixed models
      repeated measures or linear regression analyses with multiple imputations.

      Perspectives:

      The new modular and flexible manual, the centralized education and supervision of the
      psychologists, and the web-based data collection with feedback in real time was implemented
      in an explanatory feasibility trial to prepare for a future definitive RCT.
    

Intervention name(s): Mind My Mind; TAU (Treatment as Usual)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): An individual, modular and flexible cognitive and behavioural therapy; The children were offered anonymous counselling, supportive talk therapy, pedagogical advice, network meetings, and/or individual support in the school setting. A few were offered group-based CBT-programs for selected problems, but the access to manualized treatment was generally very restricted.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: No sample size calculation was performed for this parallel, two-arm feasibility RCT. Because the study population was heterogeneous and included children with a broad spectrum of emotional and behavioral mental health problems, 100-120 children were needed in the new experimental MMM arm to answer the research questions related to implementation and acceptability of the MMM manual. Therefore the goal was to include 150 children to be randomly allocated (3:1) to MMM versus TAU. The central, computerized randomization was performed by DEFACTUM using concealed computer-generated allocation sequences with variable block size, and stratification by region (Zealand or Central Denmark), and by age (6-10 years or 11-16 years).
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cognitive and Behavioral Therapies; Children and Adolescents; Community Health Care; Early Intervention; Feasibility Study