Anxiety Clinical Trial
Official title:
Randomized Trial of a Transdiagnostic, Cognitive and Behavioral Intervention Versus Treatment as Usual in School-aged Children With Emotional and Behavioral Disturbances
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.
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