Prevention of internalizing difficulties in the middle years: Protocol for a noninferiority randomized trial of Mindfulness-Based Cognitive Therapy for Children and Cognitive Behavioural Therapy.

A trial protocol compares Mindfulness-Based Cognitive Therapy for Children (MBCT-C) with traditional Cognitive Behaviour Therapy (CBT), both including a parent module, as targeted preventive programs for internalizing difficulties in children aged 9–12 from socio-economically disadvantaged primary schools in South Australia. The two-armed randomized controlled non-inferiority trial will enroll 194 children showing signs of shyness, withdrawal, or worry, along with their parents. Child self-report measures include depression, anxiety, attention, mindfulness, and self-compassion; parent measures include depression, anxiety, mindfulness, and parent-child relationship strength. The primary outcome is child anxiety and depression measured at pre- and post-intervention and at 3, 6, 12, and 15 months. The trial aims to determine longer-term effectiveness and the feasibility of adding a parent module.

Study at a glance

Abstract

Mindfulness-based interventions have been tested as preventive programs for childhood internalizing difficulties, but most research has been at a 'universal' level with small to null effects. Mindfulness-Based Cognitive Therapy for Children (MBCT-C) has similar effects to Cognitive Behaviour Therapy (CBT) when used as a small-group, targeted preventive program. Knowledge gaps include the longer-term effectiveness of MBCT-C relative to CBT and the benefits of adding a parent module. This trial aims to compare MCBT-C to traditional CBT, including a parent module, to 15-months post-intervention and to test the feasibility and acceptability of adding a parent module. Participants will be recruited from primary schools in areas of socio-economic disadvantage in South Australia (n = 194). Children (aged 9-12) years with signs of internalizing difficulties (e.g., shy, withdrawn, worried), and their parents, will be eligible for this two-armed randomized controlled non-inferiority trial (RCT). Children will participate in 10 group sessions of MBCT-C or CBT, facilitated by psychologists, and parents from both conditions will participate in two parent-only group sessions. Child self-report measures include depression and anxiety, as well as attention, mindfulness and self-compassion. Parent measures include symptoms of depression and anxiety, mindfulness, and parent-child relationship strength. The primary outcome will be child anxiety and depression (Revised Child Anxiety and Depression Scale-25). Measures will be collected pre and post intervention, and at 3, 6, 12 and 15-month follow up. Schools will be recruited from October 2022. Nomination of children will commence from February 2023. Program implementation will begin May 2023. This trial will have implications for the feasibility of involving parents in preventative programs, as well as whether mindfulness-based interventions prevent internalizing difficulties over time.