Clinical trial NCT03448809: Randomized Feasibility Trial of Mind My Mind
Official title: A Randomized Feasibility Trial of a New Transdiagnostic Cognitive and Behavioral Intervention Versus Treatment as Usual in School-aged Children With Emotional and Behavioral Disturbances
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Anxiety Disorders
Depressive Symptoms
Depressive Disorder
Problem Behavior
Oppositional Defiant Disorder
Conduct Disorder
Behavior Disorders
Keywords: Cognitive and Behavioral Therapies
Children and Adolescents
Community Health Care
Early Intervention
Feasibility Study
Lead sponsor: Mental Health Services in the Capital Region, Denmark
Sponsor class: OTHER
Collaborators: name: TrygFonden, Denmark
name: The Danish Mental Health Foundation
First posted: 2018-02-28
Enrollment: 150
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Aged 6-16 years and in 0-9th grade (excluding the second semester of the 9th grade).
2. Bother genders.
3. Child and/or parents report that the child has problems within the domains of anxiety, depressive symptoms and behavioral problems.
4. SDQ scores reported by the parent are above the lower cutoff: a total difficulties score of ≥14 and/or emotional problems ≥5; combined with a functional impairment score of ≥1.
5. The child and at least one of the two parents understand and speak Danish sufficiently to participate in the treatment.
6. Written informed consent from the holders of the parental rights and responsibilities (usually both parents).

Exclusion Criteria:

1. Indications based on the available information that the child may have a severe mental disorder like autism spectrum disorder, ADHD, schizophrenia-like psychosis, an eating disorder, or other mental disorder requiring referral to a more intensive assessment or treatment in child and adolescent mental health services (after systematic assessment and according to the usual recommendations and guidelines).
2. Indications of intellectual functional impairment, severe learning difficulties or other special needs that would interfere negatively with the MMM training. The judgment is made as a best estimate by the PPR psychologist on the basis of the available information. A formal intelligence test is not required.
3. The child has a clinically significant abuse of alcohol or psychoactive drugs
4. Parents did not answer the SDQ and CBCL during visitation

Primary outcomes:
measure: The flow of participants through the visitation.
timeFrame: At baseline (week 0).
measure: The family and social background characteristics.
timeFrame: At baseline (week 0).
measure: The Strengths and Difficulties Questionnaire (SDQ).
timeFrame: At baseline (week 0).
measure: The retention of children in the MMM arm.
timeFrame: At end of treatment (week 14).
measure: The proportion of children in the MMM arm who were referred to more specialized services during the study period.
timeFrame: At end of treatment (week 14)
measure: The satisfaction with MMM sessions among children and parents in the MMM arm.
timeFrame: Within one week after each MMM session.
measure: The dosing and sequencing of the MMM modules.
timeFrame: Within one day after each MMM session.
measure: The authorized Danish version of the Achenbach System of Empirically Based Assessment (ASEBA), Child Behaviour Checklist (CBCL).
timeFrame: At baseline (week 0)
measure: The authorized Danish version of the Achenbach System of Empirically Based Assessment (ASEBA), the Youth Self-Report (YSR).
timeFrame: At baseline (week 0)
Secondary outcomes:
measure: Spence Children's Anxiety Scale (SCAS)
timeFrame: Baseline (week 0), end of treatment (week 14), and follow-up (week 22).
measure: The Mood and Feelings Questionnaire (MFQ)
timeFrame: Baseline (week 0), end of treatment (week 14), and follow-up (week 22).
measure: The KIDSCREEN
timeFrame: Baseline (week 0), end of treatment (week 14), and follow-up (week 22).
measure: Eyberg Child Behaviour Inventory (ECBI)
timeFrame: Baseline (week 0), end of treatment (week 14), and follow-up (week 22).
measure: Weiss Functional impairment rating Scale (WFIRS)
timeFrame: Baseline (week 0), end of treatment (week 14), and follow-up (week 22).
measure: Parental Stress Scale (PSS)
timeFrame: Baseline (week 0), end of treatment (week 14), and follow-up (week 22).
measure: The Experience of Service Questionnaire (ESQ)
timeFrame: Baseline (week 0), end of treatment (week 14), and follow-up (week 22).
measure: Top-3-problems
timeFrame: Baseline (week 0), weekly during treatment, end of treatment (week 14), and follow-up (week 22).
measure: The Brief Problem Monitor (BPM)
timeFrame: Baseline (week 0), weekly during treatment, end of treatment (week 14), and follow-up (week 22).
measure: The Strengths and Difficulties Questionnaire (SDQ).
timeFrame: Baseline (week 0), weekly during treatment, end of treatment (week 14), and follow-up (week 22).
Other outcomes:
Locations:
Study officials:
affiliation: Child and Adolescent Mental Health Centre, Mental Health Services of the Capital Region of Denmark
name: Pia Jeppesen, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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