Study protocol of an RCT of EMOTION: An indicated intervention for children with symptoms of anxiety and depression

BACKGROUND High levels of anxiety and depression are common psychological symptoms among children and adolescents. These symptoms affect young people in multiple life domains and are possible precursors of long-term psychological distress. Despite relatively high prevalence, few children with emotional problems are referred for clinical treatment, indicating the need for systematic prevention. The primary aim of this study is to evaluate an indicated preventive intervention, EMOTION Coping Kids Managing Anxiety and Depression (EMOTION), to reduce high levels of anxiety and depressive symptoms. METHODS/DESIGN This is a clustered randomized controlled trial involving 36 schools, which are assigned to one of two conditions: (a) group cognitive behavioral intervention EMOTION or (b) treatment as usual (TAU). Assessments will be undertaken at pre-, mid - intervention, post-, and one year after intervention. The children (8-11 years old) complete self-report questionnaires. Parents and teachers report on children. The primary outcome will be changes in depressive and anxiety symptoms as measured by the Short Mood and Feelings Questionnaire (SMFQ) and Multidimensional Anxiety Scale for Children (MASC) respectively. Secondary outcomes will be changes in self-esteem, quality of life, and school and daily functioning. Observers will assess implementation quality with ratings of fidelity based on video recordings of group leaders leading the EMOTION group sessions. DISCUSSION The present study is an important contribution to the field regarding working with children with symptoms of anxiety and depression. The results of this study will provide an indication whether or not the EMOTION program is an effective intervention for the prevention of later depression and/or anxiety in children. The study will also provide information about the EMOTION program's effect on quality of life, self-esteem, and school functioning of the children participating in the study. Finally, the project will provide insight into implementation of an indicated intervention for school-aged children within Norwegian health, education, and mental health services. TRIAL REGISTRATION Clinical Trials NCT02340637 , Registered on June 12, 2014, last updated on January 15, 2015. Retrospectively registered.