Trial Review

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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
Comparing the effectiveness of Mindfulness-Based Cognitive Therapy for Children (MBCT-C) to traditional Cognitive Behavioral Therapy (CBT), for prevention of internalizing difficulties in upper Primary School children.
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] 302034 0
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 318613 0
depression 318614 0
attention difficulties 318615 0
self-compassion 318616 0
mindfulness 318617 0
strength (conflict and closeness) of the parent-child relationship 318618 0
Condition category
Condition code
Mental Health 316632 316632 0 0
Anxiety
Mental Health 316633 316633 0 0
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] 318330 0
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] 324754 0
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] 324754 0
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] 324760 0
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] 324760 0
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] 385679 0
Children: between-group change in the Attention Control Scale (ACS; Derryberry & Reed, 2002)
Timepoint [1] 385679 0
Baseline, post-intervention (within 4 weeks of program completion), 3-, 6-, 12-, and 15-months post-intervention.
Secondary outcome [2] 385680 0
Children: between-group change in the Child and Adolescent Mindfulness Measure (CAMM; Greco, Baer, & Smith, 2011)
Timepoint [2] 385680 0
Baseline, post-intervention (within 4 weeks of program completion), 3-, 6-, 12-, and 15-months post-intervention.
Secondary outcome [3] 385681 0
Children: between-group change in the Self-Compassion Scale for Children (SCS-C; Sutton, Schonert-Reichl, Wu, & Lawlor, 2018)
Timepoint [3] 385681 0
Baseline, post-intervention (within 4 weeks of program completion), 3-, 6-, 12-, and 15-months post-intervention.
Secondary outcome [4] 385682 0
Adults: between-group change in the Depression, Anxiety, Stress Scale (DASS; Crawford & Henry, 2003)
Timepoint [4] 385682 0
Baseline, post-intervention (within 4 weeks of program completion), 3-, 6-, 12-, and 15-months post-intervention.
Secondary outcome [5] 385683 0
Adults: between-group change in the Five Factor Mindfulness Questionnaire (FFMQ; Baer et al., 2008)
Timepoint [5] 385683 0
Baseline, post-intervention (within 4 weeks of program completion), 3-, 6-, 12-, and 15-months post-intervention.
Secondary outcome [6] 385684 0
Adults: between-group change in the Child-Parent Relationship Scale (CPRS; Driscoll & Pianta, 2011)
Timepoint [6] 385684 0
Baseline, post-intervention (within 4 weeks of program completion), 3-, 6-, 12-, and 15-months post-intervention.
Secondary outcome [7] 385686 0
Between-group differences for child program evaluation questionnaires (adapted from R J Semple & Lee, 2014).
Timepoint [7] 385686 0
Post-intervention only (within 4 weeks of program completion)
Secondary outcome [8] 385690 0
Fidelity of implementation assessed using the Session Feedback Forms completed by program facilitators. Session Feedback Forms were designed for a previous RCT of MBCT-C (Wright, Roberts, & Proeve; Wright et al., 2019).
Timepoint [8] 385690 0
1 form will be completed per faciliator per session. Descriptive statistics will be analysed by session, and for each program overall.
Secondary outcome [9] 396730 0
Between-group differences for parent program evaluation questionnaires (adapted from R J Semple & Lee, 2014).
Timepoint [9] 396730 0
Post-intervention only (within 4 weeks of program completion)

Eligibility
Key inclusion criteria
Children aged 9-12 years, who appear to be: worrying a lot, being very quiet or shy, feeling down a lot of the time, or appearing to be anxious.

Parent/guardian: being a parent or guardian of a child who is eligible for and enrolled in the current trial.
Minimum age
9 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
The program is not suitable for children who are
*8 years or younger (and not turning 9 within the 10-week program implementation period),
*Older than 12 years
*Diagnosed with a developmental disorder that is likely to significantly effect their ability to learn new concepts or experience emotions (such as Down Syndrome).

Parents/guardians: presence of a condition that is likely to significantly restrict an adult’s ability to learn new concepts or experience emotions (such as certain acquired brain injuries; or early-onset Alzheimer’s).

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation. Children will be allocated to program (1:1 ratio) using random permuted blocks with stratification by school, gender, and age.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample size calculation was conducted using methods described by Jones et al., (1996) for equivalence trials, based on the selected core measure, the Revised Child Anxiety and Depression Scale-25 (RCADS; Ebesutani et al., 2012). Primary consideration was given to the clinical significance of a difference in change scores between programs at the post-intervention time point. Clinically significant change was calculated as a minimum mean difference of 5.5 points, assuming a population standard deviation of 9.47 (taken from normative sample data for children in Grades 3-8; (Ebesutani et al., 2012).
Using a type 1 error probability of 0.05, and type 2 error probability of 0.80, the minimum number of participants required per group would be 52. An additional 10% was added for potential loss to follow-up, and 16% for clustering (assuming an average of 9 children per group and ICC of 0.02). This resulted in a final sample size of 132 children (66 per therapy group).

Quantitative data will be analysed using hierarchical multi-level mixed models (time point, children, and schools). Other factors may be entered as covariates (gender, age, number of sessions attended).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/01/2023
Actual
Date of last participant enrolment
Anticipated
14/04/2023
Actual
Date of last data collection
Anticipated
26/10/2024
Actual
Sample size
Target
264
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 306455 0
Government body
Name [1] 306455 0
The Commonwealth of Australia represented by Department of Health
Country [1] 306455 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
South Australian Health and Medical Research Institute Limited (SAHMRI)
Address
North Terrace, ADELAIDE SA 5000
Country
Australia
Secondary sponsor category [1] 306984 0
University
Name [1] 306984 0
The University of Adelaide, School of Psychology
Address [1] 306984 0
North Terrace, Adelaide, SA 5005
Country [1] 306984 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306662 0
The University of Adelaide Human Research Ethics Committee
Ethics committee address [1] 306662 0
Ethics committee country [1] 306662 0
Australia
Date submitted for ethics approval [1] 306662 0
26/08/2020
Approval date [1] 306662 0
16/09/2020
Ethics approval number [1] 306662 0
H-2020-191

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 104598 0
Dr Amanda Taylor
Address 104598 0
School of Psychology, University of Adelaide, North Terrace, Adelaide SA 5000
Country 104598 0
Australia
Phone 104598 0
+61 8 8313 4485
Fax 104598 0
Email 104598 0
amanda.taylor@adelaide.edu.au
Contact person for public queries
Name 104599 0
Amanda Taylor
Address 104599 0
School of Psychology, University of Adelaide, North Terrace, Adelaide SA 5000
Country 104599 0
Australia
Phone 104599 0
+61 8 8313 4485
Fax 104599 0
Email 104599 0
amanda.taylor@adelaide.edu.au
Contact person for scientific queries
Name 104600 0
Amanda Taylor
Address 104600 0
School of Psychology, University of Adelaide, North Terrace, Adelaide SA 5000
Country 104600 0
Australia
Phone 104600 0
+61 8 8313 4485
Fax 104600 0
Email 104600 0
amanda.taylor@adelaide.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We have not yet applied for ethics approval for IDP.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.