Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001383752
Ethics application status
Approved
Date submitted
20/10/2022
Date registered
28/10/2022
Date last updated
28/01/2024
Date data sharing statement initially provided
28/10/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The Momentum Program: Online Cognitive Behavioural Therapy (CBT) for Child Anxiety and Sleep Comorbidity
Scientific title
Efficacy of Online CBT for Child Anxiety and Sleep Comorbidity on Symptom Severity: A Randomised Controlled Trial of the Momentum Program
Secondary ID [1] 308225 0
None
Universal Trial Number (UTN)
U1111-1284-1246
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 327984 0
Sleep problems 327985 0
Condition category
Condition code
Mental Health 325040 325040 0 0
Anxiety
Mental Health 325041 325041 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The design involves a two-arm parallel-group RCT where children aged 7-12 years with comorbid anxiety and sleep probelms will be randomly assigned to either the online comorbid (COM) program condition targeting comorbid anxiety and sleep problems, or the online primary diagnosis (PRI) program condition targeting the primary presenting problem of anxiety. Both arms (i.e. Intervention Arm 1 and Intervention Arm 2) will receive an online intervention program.

The online programs will be accessed via the Momentum platform (https://momentumhub.org.au). The online interventions on the Momentum platform are self-directed and there is no contact with a therapist or a psychologist. The intervention program will be either 7 (PRI program) or 10 (COM program) sessions. The sessions will become available weekly. Each session does not have to be completed in one go, but each session will need to be completed before the participants move on to the next one. The users will receive automated reminders related to session availability. On the home page, the users will be able to monitor how far they are in their assigned program.

The Momentum program sessions have been co-designed with children to ensure they are engaging and interactive. Sessions include the use of images, interactive elements, pop-up messages, and quizzes that provide immediate feedback. Each session comprises approximately 30 slides and takes an estimated 45 minutes to complete. Number of sessions will change depending on the intervention arms. Homework assignments can be completed online or can be printed out. Each session follows a similar format: (1) Feelings check-in (where the young person completes brief anxiety and sleep questionnaires); (2) A review of homework from the previous session; (3) A summary quiz of the previous session; (4) Presentation of the main content of the session (e.g., cognitive restructuring); (5) A quiz to see what they have learned from the session; and (6) Homework activities to be completed over the following week. The sessions will include reminders to children for asking their parents to help them with their sessions and/or homework.

Intervention Arm 1: Program targeting comorbidity of anxiety and sleep problems (COM)

This program will be provided to those participants with primary anxiety and secondary sleep problems, who have been allocated to the COM arm of the RCT. This COM program involves 10 sessions. The anxiety content of the PRI and COM programs is identical. Session 1 will focus on psychoeducation around anxiety. Sessions 2-4 will focus on anxiety-specific skills (i.e., relaxation, avoidance and exposure). Sessions 5-6 will focus on cognitive restructuring. Session 7 will focus on relapse prevention for anxiety. Sessions 8-9 will focus on sleep problems. Session 10 will focus on reminders of the strategies on anxiety and sleep problems, and a final quiz.
Intervention code [1] 324684 0
Treatment: Other
Intervention code [2] 324685 0
Behaviour
Comparator / control treatment
Intervention Arm 2- Program targeting primary presenting problem - anxiety (PRI)  

The Momentum program sessions targeting primary problem have the same format and duration as the sessions targeting comorbidity (as described above). The sessions have been co-designed with children to ensure they are engaging and interactive. Sessions include the use of images, interactive elements, pop-up messages, and quizzes that provide immediate feedback. Each session comprises approximately 30 slides and takes an estimated 45 minutes to complete. Number of sessions will change depending on the intervention arms. Homework assignments can be completed online or can be printed out. Each session follows a similar format: (1) Feelings check-in (where the young person completes brief anxiety and sleep questionnaires); (2) A review of homework from the previous session; (3) A summary quiz of the previous session; (4) Presentation of the main content of the session (e.g., cognitive restructuring); (5) A quiz to see what they have learned from the session; and (6) Homework activities to be completed over the following week.

This program will be provided to those participants with primary anxiety and secondary sleep problems, who have been allocated to the PRI arm of the RCT. This PRI program involves 7 sessions. Session 1 focuses on psychoeducation around anxiety. Sessions 2-4 focus on relaxation, understanding the avoidance cycle and exposure. Sessions 5-6 focus on cognitive restructuring. Session 7 focuses on relapse prevention.
Control group
Active

Outcomes
Primary outcome [1] 332862 0
Child anxiety symptoms

Child anxiety symptoms will be assessed with the Spence Children’s Anxiety Scale-Parent version (SCAS-P; Nauta et al., 2004).
Timepoint [1] 332862 0
Pre-intervention
Post-completion of program (primary endpoint)
6-month post-baseline follow up
12-month post-baseline follow up
Primary outcome [2] 332863 0
Child sleep problems

Child sleep difficulties will be assessed with PROMIS Pediatric Sleep Disturbance Form – Parent proxy version (Forrest et al., 2018).
Timepoint [2] 332863 0
Pre-intervention
Post-completion of program (primary endpoint)
6-month post-baseline follow up
12-month post-baseline follow up
Secondary outcome [1] 414891 0
Quality of life

Child quality of life will be assessed with the Child Health Utility 9 Index (CHU9; Stevens, 2012). Parents provide a rating for each domain based on five levels of increasing severity considering their child’s day.
Timepoint [1] 414891 0
Pre-intervention
Post-completion of program
6-month post-baseline follow up
12-month post-baseline follow up
Secondary outcome [2] 414892 0
Treatment satisfaction and acceptability

Treatment satisfaction and acceptability will be assessed at post-intervention with a 6-item questionnaire adapted from March et al. (2009), in which child participants are asked to rate their program satisfaction on a 5-point scale at the end of the program.
Timepoint [2] 414892 0
Post-completion of program

Eligibility
Key inclusion criteria
Following registration and the initial assessment process that is part of the open access Momentum Platform, children aged 7-12 years who are found to demonstrate comorbid anxiety and sleep problems will be invited to participate in the RCT. Participants must be willing to participate in either of the two conditions (COM or PRI).
Minimum age
7 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Potential participants will be excluded if the child (i) has an intellectual or a developmental disorder (autism, developmental delay); (ii) is receiving psychological or psychiatric treatment for their identified problems (anxiety or sleep); (iii) is not stabilised on a medication prior to enrolment into this study or alters their medication dosage during the trial (if the participant is using medication for anxiety or sleep).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will be done by central randomisation by the Momentum Platform hosted by GreenAnt Networks secure servers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Eligible participants will proceed on to the RCT study and will be randomised in a 1:1 ratio to either the COM or PRI condition using a central, web-based randomisation service hosted by GreenAnt Networks secure servers. Random allocation will occur after stratification by gender. Following random allocation to condition, participants will be provided access to and begin their allocated program immediately.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All variables will be examined for outliers, inter- and intra-measure consistency, normality and for obviously erroneous data. Preliminary analyses will compare groups on demographic and clinical characteristics at baseline using linear (for continuous measures) or logistic (for categorical or severely skewed measures) regression. Due to randomisation, we anticipate no systematic between group differences in data other than that which has been hypothesised. However, if differences are detected we will investigate and report the extent to which the results are altered when these differences are statistically controlled for. To evaluate intervention effects, we will use mixed-effects linear regression to take into account repeated measurements within participants.

The power calculation is based on a 2 (Condition: COM vs PRI) x 2 (Time: pre-assessment and post-intervention) repeated measures design. Considering the participants in both conditions are receiving active intervention programs, we have decided to calculate our sample size based on the small interaction effect (Cohen’s f=0.1). With 80% power and alpha at 0.05, according to a two-tailed hypothesis, we need 100 participants per condition to obtain a small significant interaction effect (200 participants in total). Our planned sample of 270 allows for the potential attrition of 35% of participants (Spence et al., 2017), and the proposed sample size will provide sufficient power to conduct the proposed analyses.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Other reasons/comments
Other reasons
Technological / IT delays
Date of first participant enrolment
Anticipated
1/02/2023
Actual
Date of last participant enrolment
Anticipated
31/12/2023
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
270
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 312480 0
Government body
Name [1] 312480 0
National Health and Medical Research Council - Medical Research Future Fund (MRFF)
Country [1] 312480 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
176 Messines Ridge Rd.
Mt Gravatt QLD 4122
Country
Australia
Secondary sponsor category [1] 314066 0
University
Name [1] 314066 0
University of Southern Queensland
Address [1] 314066 0
USQ Springfield
37 Sinnathamby Blvd.
Springfield Central
QLD 4300
Country [1] 314066 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311822 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 311822 0
Ethics committee country [1] 311822 0
Australia
Date submitted for ethics approval [1] 311822 0
15/09/2022
Approval date [1] 311822 0
12/10/2022
Ethics approval number [1] 311822 0
GU Ref No: 2022/745

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

Contacts
Principal investigator
Name 122490 0
Prof Caroline Donovan
Address 122490 0
School of Applied Psychology
Griffith University
Mt Gravatt Campus
176 Messines Ridge Rd.
Mt Gravatt QLD 4122
Country 122490 0
Australia
Phone 122490 0
+61 737353401
Fax 122490 0
Email 122490 0
[email protected]
Contact person for public queries
Name 122491 0
Caroline Donovan
Address 122491 0
School of Applied Psychology
Griffith University
Mt Gravatt Campus
176 Messines Ridge Rd.
Mt Gravatt QLD 4122
Country 122491 0
Australia
Phone 122491 0
+61 737353401
Fax 122491 0
Email 122491 0
[email protected]
Contact person for scientific queries
Name 122492 0
Caroline Donovan
Address 122492 0
School of Applied Psychology
Griffith University
Mt Gravatt Campus
176 Messines Ridge Rd.
Mt Gravatt QLD 4122
Country 122492 0
Australia
Phone 122492 0
+61 737353401
Fax 122492 0
Email 122492 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified data pertaining to primary and secondary outcomes may be shared. De-identified data will be shared with researchers under circumstances where the researchers have appropriate ethics approvals and appropriate research questions.
When will data be available (start and end dates)?
Data will only become available after all data has been analysed and results published from the trial. This includes both primary research questions, secondary research questions and those arising from the study later. The start and end dates for when the data will or will not be available are to be determined.
Available to whom?
This de-identified data may be available to other researchers who hold suitable ethical clearance and wish to collaborate with the investigator team.
Available for what types of analyses?
The de-identified data may be available for review and meta-analytic purposes or other analyses on request.
How or where can data be obtained?
The data can be obtained from the primary investigator at [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17406Ethical approval  [email protected]
17427Informed consent form  [email protected]



Results publications and other study-related documents

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