Trials / Completed

CompletedNCT03448809

Randomized Feasibility Trial of Mind My Mind

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

Status: Completed
Phase: N/A
Study type: Interventional
Enrollment: 150 (actual)

Sponsor: Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital · Academic / Other
Sex: All
Age: 6 Years – 16 Years
Healthy volunteers: Not accepted

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.

Conditions

Interventions

Type	Name	Description
BEHAVIORAL	Mind My Mind	An individual, modular and flexible cognitive and behavioural therapy
BEHAVIORAL	TAU (Treatment as Usual)	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.

Timeline

Start date: 2015-12-08
Primary completion: 2017-04-02
Completion: 2017-04-02
First posted: 2018-02-28
Last updated: 2018-02-28

Source: ClinicalTrials.gov record NCT03448809. Inclusion in this directory is not an endorsement.