Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001493730
Ethics application status
Approved
Date submitted
14/11/2022
Date registered
29/11/2022
Date last updated
15/04/2024
Date data sharing statement initially provided
29/11/2022
Date results information initially provided
15/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A Cognitive Bias Modification of Interpretations Intervention for Children with Anxiety and Depressive Symptoms
Scientific title
A Cognitive Bias Modification of Interpretations Intervention for Children with Anxiety and Depressive Symptoms
Secondary ID [1] 308403 0
None
Universal Trial Number (UTN)
U1111-1284-9747
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 328202 0
Depression 328203 0
Condition category
Condition code
Mental Health 325255 325255 0 0
Anxiety
Mental Health 325256 325256 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This project aims to evaluate the efficacy of a cognitive bias modification of interpretations (CBM-I) intervention for children aged 8 to 10 years old with anxiety and/or depressive symptoms. We aim to evaluate its effectiveness versus a waitlist control group at post-intervention and after a one month follow up.

Participants allocated to the intervention will receive the CBM-I intervention delivered in an online format. Access to the intervention will be password-protected on a website. Participants will complete the intervention on personal devices (e.g. computer, tablet, phone) within their own homes. The intervention has been specifically designed for children by a team of psychologists, researchers, user experience designers and software developers at the Black Dog Institute with co-design input from lived experience children, parents and mental health professionals.

The intervention will involve 8, 10-15 minute sequential sessions four times per week over two weeks (up to three weeks). On completion of a session, the next session is only available for completion on the following day. The intervention is designed to encourage positive or benign interpretations of ambiguous situations and is based on similar tasks used by members of the project team.

During every trial, children will be presented with a short 2-3 sentence scenario describing an uncertain situation that might happen to them. Children will be asked to imagine the scenario as happening to themselves as vividly as possible. Each scenario will be followed by two options, one describing a positive or benign outcome, and the other presenting a negative outcome. Children will be asked to read the scenario and two possible outcomes and then choose one of the outcomes. The scenario will then disappear from the screen and will be replaced with feedback on their choice that reinforces the positive/benign interpretation. Each session will contain 15 training scenarios (total 120 scenarios). In addition to the training trials, children will be presented with short pieces of narrative in between trials. The inclusion of the narrative is designed to promote engagement in the intervention by providing additional context to the scenarios, which was identified as important during the co-design process. All scenarios, narrative, response options, and feedback will be presented as text. A proportion of the scenarios (approximately 3-4 per session) will be accompanied by an image. The images are not designed to enhance the scenarios or intervention, but rather to increase engagement in the online program.

The scenarios used in the intervention are matched to anxiety and depressive concerns commonly experienced by children (e.g., generalised concerns, social concerns, separation concerns and depressive concerns) and adapted from previous materials. To ensure relevance and matching of training content to children’s concerns, 40% of the scenarios will be matched to the child’s primary concern. Primary concerns will be identified based on a basic algorithm of subscale scores on the symptom questionnaire measures.

Participants will receive points for “correct” responses (i.e., selection of the positive/benign option) and no points for “incorrect” responses (i.e., negative option). These points can be redeemed for illustrative icons within the digital program (e.g., medals, trophies or ribbons). Participants will also receive rewards as they progress through the program. The rewards will be set up by parents and children at the start of the intervention and delivered by parents.

Participants allocated to the intervention will receive a weekly email check in to assist with session scheduling and can opt to receive a phone call with a researcher to answer questions about the program and assist with session scheduling. No additional contact with participants will be made, except if risk management phone calls or technical support for the intervention is required.

For participants allocated to the intervention, the study will also collect research data associated with their engagement and use of the intervention. This trial will collect the following usage data from the intervention: number of sessions completed and individual responses to training activities.
Intervention code [1] 324855 0
Behaviour
Intervention code [2] 324856 0
Treatment: Other
Comparator / control treatment
The training will be compared to a waitlist control condition. Following completion of the baseline assessments, participants will be randomised to one of the two conditions using a computerised randomisation procedure in Qualtrics. Parents of participants allocated to the waitlist control condition will be emailed and asked to wait 3-4 weeks to begin the intervention. Following completion of the post-wait period questionnaires, participants in the waitlist control group will be emailed with instructions and login details to the intervention.
Control group
Active

Outcomes
Primary outcome [1] 333103 0
The first primary outcome is negative interpretation bias. Negative interpretation bias scores (child-report) will be measured using the Ambiguous Scenarios Task (AST)
Timepoint [1] 333103 0
Negative interpretation bias will be measured on the AST measure at baseline, post training/post-waitlist (4 weeks after baseline), and at follow up (follow-up for intervention group only - measured 8 weeks after baseline).
Primary outcome [2] 334842 0
The second primary outcome is positive interpretation bias. Positive interpretation bias scores (child-report) will be measured using the Ambiguous Scenarios Task (AST)
Timepoint [2] 334842 0
Positive interpretation bias will be measured on the AST measure at baseline, post training/post-waitlist (4 weeks after baseline), and at follow up (follow-up for intervention group only - measured 8 weeks after baseline).
Secondary outcome [1] 415824 0
Anxiety symptoms will be measured using the Revised Children's Anxiety and Depression Scale 25 (RCADS-25) parent- and child-report versions
Timepoint [1] 415824 0
Anxiety symptoms will be measured on the RCADS-25 measure at baseline, post training/post-waitlist (4 weeks after baseline), and at follow up (follow-up for intervention group only - measured 8 weeks after baseline). The primary timepoints is post-training/post waitlist.
Secondary outcome [2] 415825 0
Children's life interference will be measured using the Children’s Anxiety and Depression Life Interference Scale – parent-report (CADLIS–P).
Timepoint [2] 415825 0
Life interference will be measured on the CADLIS-P measure at baseline, post training/post-waitlist (4 weeks after baseline), and at follow up (follow-up for intervention group only - measured 8 weeks after baseline).
Secondary outcome [3] 415826 0
Children's life interference will be measured using the Children’s Anxiety and Depression Life Interference Scale – child-report (CADLIS–C).
Timepoint [3] 415826 0
Life interference will be measured on the CADLIS-C measure at baseline, post training/post-waitlist (4 weeks after baseline), and at follow up (follow-up for intervention group only - measured 8 weeks after baseline).
Secondary outcome [4] 415827 0
Anxiety symptoms on items relevant to social or generalised concerns will be measured using the Spence Children’s Anxiety Scale, parent-report (SCAS-P). This information will supplement RCADS25 anxiety items to calculate subscale scores for generalised anxiety and social anxiety.
Timepoint [4] 415827 0
Anxiety symptoms will be measured on the SCAS-P measure at baseline, post training/post-waitlist (4 weeks after baseline), and at follow up (follow-up for intervention group only - measured 8 weeks after baseline).
Secondary outcome [5] 415828 0
Anxiety symptoms on items relevant to social or generalised concerns will be measured using the Spence Children’s Anxiety Scale, child-report (SCAS-C). This information will supplement RCADS25 anxiety items to calculate subscale scores for generalised anxiety and social anxiety.
Timepoint [5] 415828 0
Anxiety symptoms will be measured on the SCAS-C measure at baseline, post training/post-waitlist (4 weeks after baseline), and at follow up (follow-up for intervention group only - measured 8 weeks after baseline).
Secondary outcome [6] 415829 0
For participants allocated to the intervention, the study will also collect research data associated with their engagement and use of the intervention. This trial will collect the following usage data from the intervention: number of sessions completed and individual responses to training activities. This information will be recorded by Qualtrics automatically as participants complete the intervention, as the intervention website is liked to Qualtrics. This data will be downloaded from Qualtrics and connected to their assessment data using the unique participant identification code.
Timepoint [6] 415829 0
Intervention use data will be collected throughout the intervention.
Secondary outcome [7] 415988 0
Barriers to digital program use will be measured using the Barriers questionnaire (parent-report).
Timepoint [7] 415988 0
Barriers to digital program use will be measured post-training (4 weeks after baseline) for the intervention group only.
Secondary outcome [8] 415989 0
Digital program satisfaction will be measured using the Digital Satisfaction Questionnaire (parent-report).
Timepoint [8] 415989 0
Digital satisfaction will be measured post-training (4 weeks after baseline) for the intervention group only.
Secondary outcome [9] 415990 0
Digital program satisfaction will be measured using the Digital Satisfaction Questionnaire (child-report).
Timepoint [9] 415990 0
Digital satisfaction will be measured post-training (4 weeks after baseline) for the intervention group only.
Secondary outcome [10] 419139 0
In addition to the CADLIS, interference will also be measured using two interference questions. These will measure the extent to which anxiety or low mood cause distress for the child, and impairment for the family.
Timepoint [10] 419139 0
Interference will be measured at baseline, post training/post-waitlist (4 weeks after baseline), and at follow up (follow-up for intervention group only - measured 8 weeks after baseline).
Secondary outcome [11] 419140 0
State anxiety will be measured using a 5-point Visual Analogue Scale (VAS).
Timepoint [11] 419140 0
Participants will complete the VAS measure immediately before and after each of the 8 training sessions.
Secondary outcome [12] 419141 0
State mood will be measured using a 5-point Visual Analogue Scale (VAS).
Timepoint [12] 419141 0
Participants will complete the VAS measure immediately before and after each of the 8 training sessions.
Secondary outcome [13] 419142 0
Usage data will be collected for the website the intervention website. The following usage data will be collected: Log in attempts (total frequency and frequency per day), actual usage (time spent logged into website), pages visited (e.g. home page, sessions, rewards), page visit usage time (time on each page visit), number of visits (frequency of visits on each page), avatar selected, rewards selected, badges redeems, rewards redeemed.
Timepoint [13] 419142 0
This data will be collected continuously throughout the study.
Secondary outcome [14] 420673 0
Depressive symptoms will be measured using the Revised Children's Anxiety and Depression Scale 25 (RCADS-25) parent- and child-report versions.
Timepoint [14] 420673 0
Depressive symptoms will be measured on the RCADS-25 measure at baseline, post training/post-waitlist (4 weeks after baseline), and at follow up (follow-up for intervention group only - measured 8 weeks after baseline). The primary timepoints is post-training/post waitlist.

Eligibility
Key inclusion criteria
1. Aged between 8 to 10 years (i.e., Grade 2 to 5) (parent-report)
2. Located in Australia (parent-report)
3. Reporting moderate levels of anxiety or depressive symptoms (as determined by a parent-report measure on the anxiety symptom subscale and depressive symptom subscale of the RCADS-25; t-score greater than or equal to 65 and an interference score greater than or equal to 1).
4. The child is fluent in English and is able to independently read and answer questions in English at Grade 2 level (to ensure comprehension of content) (parent-report)
5. Own or have access to an internet-enabled device (parent-report)
6. Have a parent or guardian who can provide consent for participation
Minimum age
8 Years
Maximum age
10 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Experiencing life-threatening suicidal ideation and/or had serious suicidal ideation in the last month (parent-report)
2. Have a diagnosis of an organic brain injury, psychosis, severe developmental disability, vision impairment or
physical disability that would prevent them using a computer (parent-report)
3. Fail to satisfy any of the inclusion criteria.

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)
Eligibility for inclusion in the trial will be determine automatically, based on participants' responses in the Qualtrics screener survey. The survey will determine eligibility based on answers to yes/no self-report questions of inclusion and exclusion criteria (e.g. age, device access), and questionnaire responses that are automatically scored. The Qualtrics program will only allow participants who met the inclusion criteria to continue to the baseline survey. Participants will be automatically allocated (randomised) to the intervention or control group by Qualtrics, following completion of the baseline survey. Given that determination of eligibility and allocation are conducted automatically by a computer program, allocation is concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be carried out according to the International Council for Harmonisation (ICH) guidelines. Randomisation to one of the two trial arms will be conducted immediately after completion of the baseline assessment using a computerised randomisation procedure within Qualtrics. Allocation will be fully automatic via a computerised randomisation procedure in Qualtrics, with no interference from the research team. Participants will be randomly assigned to either the CBM-I intervention or the WL in 1:1 ratio and individually stratified based on gender identity and primary symptom domain.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analyses will be undertaken on an intention-to-treat basis and will include all participants in the group to which they were randomized (regardless of actual receipt or uptake of the intervention or withdrawal from the study). Mixed-model repeated measures analysis will be used for the primary outcome and continuously scaled secondary outcome variables. Model will include factors of study condition (intervention or control group), occasion of measurement (baseline, post intervention and follow-p), and their interaction. Analyses will include the effect of the stratification variables, gender and primary symptom domain, with associated model parameters being retained if they are statistically significant.

Primary outcome
The primary outcome will be assessed by a planned comparison of the difference between groups in change of the primary outcome variable (positive and negative interpretation bias) from baseline to post training. Due to two primary outcome measures, p-values were Bonferonni-corrected for analysis, to .025 (.05/2). An unstructured residual variance-covariance matrix will accommodate within-participant dependency. Tests of significance will use the Kenward-Roger method of degrees of freedom adjustment based on the observed information matrix.

Secondary outcomes
Analyses of secondary outcome variables (anxiety and depressive symptoms, life interference) will follow the same methods as the primary outcome. Secondary analyses will also include change in the primary and other outcome variables from baseline to follow-up to inform the outcome pertaining to retention of learning. Change in the intervention group over this period cannot be compared to the waitlist as the latter group will be provided with access to the intervention post intervention. The magnitude of change within the intervention group post training to follow-up will be also estimated to reflect retention of any benefit of training.

Supporting analyses
The following app usage data will be collected for the intervention group: log in attempts, time spent on website, pages visited, page visit usage time, number of visits to each page, number of sessions completed, individual responses to training activities, avatar selected, rewards selected, badges redeemed, and rewards redeemed. This data will be examined to establish the extent of use of individual app components. Participant attributes that predict usage will also be investigated. Mediation analysis will establish the plausibility of a causal pathway of the intervention’s effect on clinical outcomes (anxiety and depression) being via change in interpretation bias.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/08/2023
Actual
23/08/2023
Date of last participant enrolment
Anticipated
30/09/2023
Actual
13/11/2023
Date of last data collection
Anticipated
Actual
31/01/2024
Sample size
Target
142
Accrual to date
Final
191
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 312654 0
Other Collaborative groups
Name [1] 312654 0
Black Dog Institute
Country [1] 312654 0
Australia
Primary sponsor type
Individual
Name
Dr Gemma Sirouri
Address
Black Dog Institute, Hospital Road, Prince of Wales Hospital,
Randwick NSW 2031
Country
Australia
Secondary sponsor category [1] 314264 0
None
Name [1] 314264 0
Address [1] 314264 0
Country [1] 314264 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311961 0
University of New South Wales - Human Research Ethics Committee
Ethics committee address [1] 311961 0
UNSW Sydney
High St
Kensington NSW 2052
Australia
Ethics committee country [1] 311961 0
Australia
Date submitted for ethics approval [1] 311961 0
07/11/2022
Approval date [1] 311961 0
15/12/2022
Ethics approval number [1] 311961 0
HC220758

Summary
Brief summary
Researchers at the Black Dog Institute have developed a new digital mental health tool for children aged 8 to 10 years who worry or experience low mood. The goal of the program is to help children to develop healthier thinking habits to help with their worry and low mood. In this study, we are conducting a clinical trial to evaluate whether the program is beneficial for children’s mental health.

The current project will investigate the efficacy of a novel Cognitive Bias Modification of Interpretations (CBM-I) intervention for children with elevated symptoms of anxiety and/or depression. The CBM-I program has been developed in consultation with children, parents and mental health professionals to maximise engagement and relevance of content and features for children with anxiety and depressive concerns. Children aged 8-10 years who are reported to experience anxiety and/or depressive symptoms above a clinical cutoff will be randomly allocated to a CBM-I intervention or a waitlist control group. Children in the intervention group will undertake eight sessions online on a home device which trains them to interpret ambiguous information more positively or neutrally. Anxiety and depressive symptoms, and interpretation bias will be assessed before and after the intervention/waitlist period.

Compared to the waitlist control group, we expect that the intervention group will report fewer symptoms and biases following the intervention/wait period and these gains will be maintained at one month follow up. We will also examine whether the intervention is enjoyable, useful, and easy to use among participants in the intervention group.

This project is significant as it will evaluate the first CBM-I intervention which targets both anxiety and depressive symptoms in children and has been co-designed in consultation with children parents and clinicians. If the intervention is found to be effective and acceptable, it has potential to be used during a waitlist for standard care (e.g., Cognitive Behavioural Therapy (CBT)).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 122978 0
Dr Gemma Sicouri
Address 122978 0
Black Dog Institute, Hospital Road, Prince of Wales Hospital, Randwick NSW 2031
Country 122978 0
Australia
Phone 122978 0
+61 2 9065 9269
Fax 122978 0
Email 122978 0
g.sicouri@blackdog.org.au
Contact person for public queries
Name 122979 0
Dr Gemma Sicouri
Address 122979 0
Black Dog Institute, Hospital Road, Prince of Wales Hospital, Randwick NSW 2031
Country 122979 0
Australia
Phone 122979 0
+61 2 9065 9269
Fax 122979 0
Email 122979 0
g.sicouri@blackdog.org.au
Contact person for scientific queries
Name 122980 0
Dr Gemma Sicouri
Address 122980 0
Black Dog Institute, Hospital Road, Prince of Wales Hospital, Randwick NSW 2031
Country 122980 0
Australia
Phone 122980 0
+61 2 9065 9269
Fax 122980 0
Email 122980 0
g.sicouri@blackdog.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
SourceTitleYear of PublicationDOI
Dimensions AICodesigned online cognitive bias modification of interpretations for anxiety and depression in children: study protocol of a randomised controlled trial2024https://doi.org/10.1136/bmjopen-2023-078652
N.B. These documents automatically identified may not have been verified by the study sponsor.