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Trial registered on ANZCTR

Registration number

ACTRN12622000156785

Ethics application status

Approved

Date submitted

17/08/2020

Date registered

31/01/2022

Date last updated

18/01/2023

Date data sharing statement initially provided

31/01/2022

Type of registration

Prospectively registered

Titles & IDs

Public title

Scientific title

Comparing the effectiveness of Mindfulness-Based Cognitive Therapy for Children (MBCT-C) to traditional Cognitive Behavioral Therapy (CBT), for prevention of internalizing difficulties (reduction in symptoms of anxiety) in at-risk, upper Primary School children located in lower SES regions of Adelaide, South Australia

Secondary ID [1]

The Commonwealth of Australia represented by Department of Health. Agreement ID 4-EFOOH7V

Universal Trial Number (UTN)

U1111-1257-0053

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

anxiety

depression

attention difficulties

self-compassion

mindfulness

strength (conflict and closeness) of the parent-child relationship

Condition category

Condition code

Mental Health

Anxiety

Mental Health

Depression

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

MBCT-C Children's Program Description
MBCT-C includes many different activities designed to help children bring their attention to the present moment, as research has shown that this may have benefits such as reducing worrying or anxious thoughts. Activities include short meditation practices, and bringing mindful attention to eating, touch, sounds, sights and smell. Children are also taught through experiential exercises to observe and understand the link between their thoughts, emotions, body sensations and behaviours.
The children's program implementation will be consistent with a 10-week program implemented in Primary Schools (Wright, Roberts, & Proeve, 2019), and this was based on an amended version of the original program (Semple & Lee, 2011). For reference, the key amendment was shortening the program (removing content) to reduce the program length from 12, to the current 10-week version. All changes were made in line with the program author's guidance.
Children participate in 10 x weekly sessions, in groups of up to 12 children. Each session is 1 hr 15 mins, to 1 hr 30 mins. Program duration is 10 weeks. Groups will be facilitated by psychologists: 1 registered psychologist working with 1 provisionally registered psychologist. Psychologists will be supervised by a Senior Clinical Psychologist from the University of Adelaide.
Children's session attendance is recorded according to the program manual (the "Being Present" board; Semple & Lee, 2011).
A key part of the MBCT-C program is short daily activities for the children to complete at home, and parents are invited to assist their child with these home practices. They are usually less than 3 minutes per activity, around three times per day. Examples include mindful breathing, mindful smelling, and mindful listening.
Children will be provided with paper copies of materials for each session, and home practices. These are sourced from the MBCT-C program manual (Semple & Lee, 2011), and will be provided in booklet format.
MBCT-C Parent/Guardian Module Description: the module will have two main components. The first is an explanation of what children are experiencing in their weekly program sessions, and the opportunity to complete some of the practices as a parent/guardian group. This will include information about how to help children manage strong emotions, and how to help parents manage strong emotional reactions in themselves. Parents/guardians participate in 2 x sessions, held at the start and end of the children's program. Each parent/guardian session is 1 hr, to 1 hr 15 mins. The groups will include up to 24 parents/guardians, and will be facilitated by psychologists (the same psychologists who facilitate the children's groups). Hard copy materials will be provided. These will include materials sourced directly from the program manual (Semple & Lee, 2011).
Parent's attendance will be recorded by facilitators during each parent session.
Facilitators will report fidelity of implementation by completing a Session Feedback Form, one per session, per program. These forms were developed to assess Fidelity of Implementation in a previous RCT (Wright, Roberts, & Proeve, 2019). This include facilitators perceptions of whether children appeared to engage with home practices each week.
References
Semple, R. J., Lee, J. (2011). Mindfulness-Based Cognitive Therapy for Anxious Children: A Manual for Treating Childhood Anxiety. United States: New Harbinger Publications.
Wright, K. M., et al. (2019). "Mindfulness-Based Cognitive Therapy for Children (MBCT-C) for Prevention of Internalizing Difficulties: a Small Randomized Controlled Trial with Australian Primary School Children." Mindfulness 10(11): 2277-2293.

Intervention code [1]

Prevention

Comparator / control treatment

Cognitive Behavioural Therapy (CBT) Children's Program Description
The CBT program selected is Cool Kids (Rapee et al., 2020). This program teaches skills to manage difficult emotions like anxiety, and increase resilience. Children learn about identifying and understanding emotions, and the links between emotions, thoughts, bodily sensations and behaviours. Children learn strategies such as relaxation, step-ladders to challenge anxiety (i.e. breaking challenges down into smaller steps), and problem-solving. Children participate in 10 x weekly sessions, in groups of up to 12 children. Each session is 1 hr, to 1 hr 15 mins. Groups will be facilitated by psychologists: 1 registered psychologist working with 1 provisionally registered psychologist. Psychologists will be supervised by a Senior Clinical Psychologist from the University of Adelaide.
Children’s attendance will be recorded by facilitators within each session.
The Cool Kids program also includes brief activities for children to complete at home, at the participants' own discretion, and parents are invited to assist their child in completing these activities. Examples are using the step-ladder strategy to tackle a particular anxiety. They are usually between 15-30 minutes per week.
Children will be provided with their own Cool Kids workbook, which includes materials for each session, and home practices (Rapee et al., 2020).
CBT Parent/Guardian Module Description: The Cool Kids parent sessions (Rapee et al., 2020) will also include an explanation of what children are experiencing in their weekly program sessions, and the opportunity to complete some of the practices as a parent/guardian group. Parents/guardians participate in 2 x sessions, held in weeks 1 and 3 of the children's program. Each parent/guardian session is up to 2 hours in length. At session 5 and 7, parents/guardians are offered a phone consultation, where they can discuss their child’s progress and help parents strengthen their own techniques for assisting their child with difficult emotions (up to 30 minutes per consultation). The groups will include up to 24 parents/guardians and will be facilitated by psychologists (the same psychologists who facilitate the children's groups). A parent/guardian workbook will be provided to parents (Rapee et al., 2020).
Parent/guardian's attendance (for the in-person sessions, and the phone consultations) will be recorded by facilitators.
Facilitators will report fidelity of implementation by completing a Session Feedback Form, one per session, per program. These forms were developed to assess Fidelity of Implementation in a previous RCT (Wright, Roberts, & Proeve, 2019). This include facilitators perceptions of whether children appeared to engage with home activities each week.
References:
Rapee, R. M., Lyneham, J. L., Withrich, V. M., Kangas, M., Schniering, C. A., Wignall, A. (2020). Cool Kids Anxiety Program 2nd edition. Melbourne: Macquarie University Centre for Emotional Health.
Wright, K. M., et al. (2019). "Mindfulness-Based Cognitive Therapy for Children (MBCT-C) for Prevention of Internalizing Difficulties: a Small Randomized Controlled Trial with Australian Primary School Children." Mindfulness 10(11): 2277-2293.

Control group

Active

Outcomes

Primary outcome [1]

Children: between-group change in anxiety symptoms as measured by the Revised Child Anxiety and Depression Scale-25 (RCADS-25-C; Ebesutani et al., 2012)

Timepoint [1]

Baseline, post-intervention (within 4 weeks of program completion), 3-, 6-, 12-, and 15-months post-intervention. The primary time-point is post-intervention.

Primary outcome [2]

Children: between-group change in depression symptoms as measured by the Revised Child Anxiety and Depression Scale-25 (RCADS-25-C; Ebesutani et al., 2012).

Timepoint [2]

Baseline, post-intervention (within 4 weeks of program completion), 3-, 6-, 12-, and 15-months post-intervention. The primary time-point is post-intervention.

Secondary outcome [1]

Children: between-group change in the Attention Control Scale (ACS; Derryberry & Reed, 2002)

Timepoint [1]