Anxiety Clinical Trial
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
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.
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.
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