Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000907640
Ethics application status
Approved
Date submitted
1/08/2023
Date registered
23/08/2023
Date last updated
20/02/2024
Date data sharing statement initially provided
23/08/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A digital anxiety intervention for children with reading difficulties
Scientific title
A randomised controlled trial of the efficacy of a digital anxiety intervention for children with reading difficulties and anxiety
Secondary ID [1] 310262 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 330962 0
Reading difficulties
 330963 0
Condition category
Condition code
Mental Health 327763 327763 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The digital anxiety intervention is a web-based and clinician-led program that delivers Cognitive Behavioural Therapy (CBT). The intervention was developed given that reading difficulties and anxiety tend to co-occur and become a vicious cycle. These children tend to struggle with understanding content of existing digital anxiety interventions as they tend to be text heavy. A team of leading researchers in the field of anxiety and reading, and user experience specialists worked collaboratively via co-design process. The co-design process involved 3 x 1-hour semi-structured interviews and 2 x 2-hour workshops (N=18; n=8 parents, n=6 children and n=4 clinicians). Researchers, clinicians and user experience specialists discussed findings from the qualitative methods to design the intervention accessible for children with reading difficulties and anxiety.

The intervention is an exposure-focused program which aims to teach children strategies to manage their anxiety. The intervention includes strategies such as gradual exposure, psychoeducation, and cognitive restructuring. The intervention will be delivered on google-classrooms and includes videos and worksheets. Children will be guided through the digital anxiety intervention with the clinician (Provisional or Registered Psychologist) via telehealth (one-on-one video calls) for 1 x 60-minute session per week for 10 weeks.

The intervention will be delivered by psychologists who are co-investigators on this study. They will have experience in working with children and delivering CBT. Psychologists will be provided with a 1 hour training and orientation session to provide them details about the study and intervention, and orient them to the therapist manual which was designed specifically for this study and provides them with a structured plan for each session. The intervention has optional strategies that the psychologist will deliver where appropriate (e.g. self-concept, calm breathing) based on baseline measures and clinical judgement.

Parents will independently work through approximately 30-min x 3 weeks of material at weeks 1, 5 and 10 which will include psychoeducation and strategies to support their children through the intervention. They will also have 3 x 30-minute sessions (at weeks 1, 5 and 10) with the clinician to help support their child. Parents will be asked to organise a private space for themselves during the session (i.e. without the child present). These calls aim to reiterate key points of the intervention (e.g. treatment rationale, expectations around progress, positive reinforcement) and problem solve any barriers.

We will select 20% of psychologist-child sessions to be transcribed and analysed for treatment integrity by independent clinicians.
Intervention code [1] 326647 0
Treatment: Other
Comparator / control treatment
The delayed waitlist control arm will receive the intervention 12 weeks from baseline following completion of their 12-week assessment.

The delayed waitlist control arm will not be restricted to accessing any other services or treatment. At 12-weeks, prior to commencing the intervention they will be administered questionnaires that assess for service use during the waiting list period.
Control group
Active

Outcomes
Primary outcome [1] 335559 0
Anxiety (parent-reported) measured by the Spences Child Anxiety Scale-Parent
Timepoint [1] 335559 0
Baseline, 5-week, 12-week (primary timepoint), and 24-week follow-ups post-baseline
Secondary outcome [1] 424953 0
Anxiety (child-reported) measured by the Spences Child Anxiety Scale-Child
Timepoint [1] 424953 0
Baseline, 5-week, 12-week, and 24-week follow-ups post-baseline
Secondary outcome [2] 424954 0
Remission of anxiety measured by the Anxiety Disorders Interview Schedule (ADIS -V) - Parent
Timepoint [2] 424954 0
Baseline and 12-week follow-up post-baseline
Secondary outcome [3] 424955 0
Reading accuracy measured by Castles and Coltheart Test 2 (CC2)
Timepoint [3] 424955 0
Baseline and 12-week follow-ups post-baseline
Secondary outcome [4] 424956 0
Reading fluency measured by Test of Word Reading Efficiency 2 (TOWRE)
Timepoint [4] 424956 0
Baseline and 12-week follow-ups post-baseline
Secondary outcome [5] 424957 0
Reading anxiety (child-reported) measured by The Macquarie Oxford Reading Anxiety Test- Child (MoRAT-C)
Timepoint [5] 424957 0
Baseline, 5-week, 12-week, and 24-week follow-ups post-baseline
Secondary outcome [6] 424958 0
Self-concept measured by Reader Self-Perception Scale (RSPS)
Timepoint [6] 424958 0
Baseline, 12-week post-intervention, and 24-week follow-up
Secondary outcome [7] 425409 0
Reading anxiety (parent-reported) measured by The Macquarie Oxford Reading Anxiety Test- Parent (MoRAT-P)
Timepoint [7] 425409 0
Baseline, 5-week, 12-week and 24-week follow-ups post-baseline

Eligibility
Key inclusion criteria
• Children aged 7-12 years in Australia
• Reading level -1 standard deviation (SD) below average on (1) one or more word lists from the Castles and Coltheart Reading test (CC2; regular, irregular or nonword lists) and/or (2) the nonword or irregular word list from the Test Of Word Reading Efficiency (TOWRE)
• Diagnosis of (1) any anxiety disorder based on the DSM-5-TR (i.e. social anxiety disorder, separation anxiety disorder, generalised anxiety disorder, panic disorder, agoraphobia, specific phobia or unspecified anxiety disorder) and/or (2) obsessive compulsive disorder assessed using the ADIS-V.
• Normal or corrected to normal vision and hearing (parent self-report)
• Willingness to give written informed consent (verbal student assent) and willingness to participate to and comply with the study.
Minimum age
7 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• A diagnosis of Autism Spectrum Disorder (as determined by parent self-report) and/or Intellectual Developmental Disorder (IQ < 75; as determined by parent-self report)
• A diagnosis of one or more of the following disorders if these disorders are the primary concern beyond anxiety: Oppositional Defiant Disorder (as determined by ADIS-V or parent self-report), Conduct Disorder (as determined by ADIS-V or parent self-report), Major Depressive Disorder (as determined by parent self-report or ADIS-V) and/or neurological condition (e.g. Epilepsy; as determined by parent self-report)
• Current life-threating suicidal ideation and/or had serious suicidal ideation in the past month (as determined through parent self-report).
• Currently receiving one-on-one therapy for anxiety with a psychologist, psychiatrist or paediatrician frequently (i.e. more frequently than once every 2 months)

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 is concealed for study psychologists who are administering ADIS-V.
Participants are randomly allocated to one of the two groups. Randomisation will be conducted via Qualtrics by researchers.

An independent administrator will use Qualtrics randomiser for treatment allocation, to ensure allocation concealment
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified randomisation using qualtrics
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
(Note: T1 = baseline, T2 = mid-intervention, T3 = post intervention (primary endpoint), T4 = follow up at 24 weeks post baseline.)
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 (MMRM) analysis will be used for the primary outcome and continuously scaled secondary outcome variables. This approach handles missing data by including all available data from each subject into the analysis and assumes missing data are missing at random. Models will include factors of study condition (intervention or waitlist group), occasion of measurement (baseline, mid, and post intervention and follow-up), and their interaction. Analyses will include the effects of the stratification variables, anxiety severity and reading accuracy, with associated model parameters being retained if they are statistically significant. A sensitivity analysis will be conducted using pattern mixture models.
Primary outcome
The primary outcome will be assessed by a planned comparison of the difference between groups in change of the primary outcome variable (intervention group) from baseline (T1) to post intervention (T3) This test will be undertaken with an alpha of .05. 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. Where necessary, transformation of the outcome variable will be undertaken to ensure distributional assumptions of the model are met.
Analysis of the proportion of participants meeting the clinical threshold for caseness (i.e. clinical cut off) on the diagnostic measures (ADIS-V, which provides diagnoses based on the DSM-V) will be assessed post baseline (T1) using mixed effects logistic regression model including participant as a random intercept effect.
Secondary outcomes
Analyses of continuous secondary outcome variables (reading accuracy, reading fluency, reading anxiety and self-concept) will follow the same methods as the primary outcome.
Secondary analyses will also include change in the primary and other outcome variables from baseline (T1) to follow-up (T4) to inform the outcome pertaining to retention of benefit.
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. Follow-up outcomes (T4) in the waitlist group will be compared to this group’s T3 scores in order to estimate change after they have accessed the intervention. We will also conduct a subgroup analysis to exclude children that no longer meet the diagnostic inclusion criteria at T3.
Subject to qualifications arising due to attrition and any natural drift over time, this analysis will stand as a quasi-replication of the primary outcome of the trial.
Supporting analyses
To perform adjusted and subgroup analyses, mixed model repeated measures (MMRM) will be used. Regression models will explore predictors of outcome. Contrasts with MMRMs will be used to compare pre- to post-intervention gains in each outcome at the group level.
A planned interim analysis will occur based on data from the 5-week timepoint using the Haybittle-Peto rule (i.e., alpha=0.001) to inform any decision to prematurely stop the trial on the grounds that the available evidence overwhelmingly indicates the effectiveness of the intervention. The final analysis will use alpha=0.05.
To assess treatment integrity and adherence of psychologists, 20% of the recorded sessions will be randomly selected, transcribed and de-identified. This will be stratified by clinicians to ensure an equal number of sessions are reviewed per clinician. These will be evaluated by independent raters against the training manual. A randomly selected sample (25%) of ADIS-V assessments will be transcribed and de-identified, and evaluated by independent raters to confirm adherence and consistency in diagnoses.

Sample size
Previous reading and anxiety training studies (McArthur et al., 2015a 2015b) and an integrated reading and anxiety intervention study (Francis et al., 2021) reported moderate-to-large effects on word reading accuracy and anxiety symptom and disorder outcomes. To detect a statistically significant moderate effect size (Cohen’s D = 0.7; based on a meta-analysis by James et al. 2020) with 80% power and alpha of 0.05, we require 34 children per group (i.e., N = 68). Thus, we aim to recruit N = 86, allowing for 20% attrition. The target sample size will allow a difference in likelihood of remission of diagnosis of 26% to be detected with 80% power assuming a rate of remission of 15% in the waitlist condition. This intended sample size was estimated in consultation with statistician, Prof Andrew Mackinnon.

Recruitment for the semi-structured interview will continue until thematic saturation. Saturation is defined as the point where no new insights on themes emerge, which will be discussed and confirmed by principal investigator and co-investigators.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
18/09/2023
Actual
24/10/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
86
Accrual to date
3
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 314470 0
Charities/Societies/Foundations
Name [1] 314470 0
Gandel Foundation
Country [1] 314470 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
UNSW Sydney, High St. Kensington NSW 2052
Country
Australia
Secondary sponsor category [1] 316429 0
None
Name [1] 316429 0
Address [1] 316429 0
Country [1] 316429 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313521 0
UNSW Human Research Ethics Committee
Ethics committee address [1] 313521 0
Ethics committee country [1] 313521 0
Australia
Date submitted for ethics approval [1] 313521 0
30/06/2023
Approval date [1] 313521 0
23/08/2023
Ethics approval number [1] 313521 0

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

Contacts
Principal investigator
Name 128430 0
Prof Jennie Hudson
Address 128430 0
Black Dog Institute, Hospital Road, Randwick NSW 2031
Country 128430 0
Australia
Phone 128430 0
+61 2 9065 9251
Fax 128430 0
Email 128430 0
[email protected]
Contact person for public queries
Name 128431 0
Deanna Francis
Address 128431 0
Black Dog Institute, Hospital Road, Randwick NSW 2031
Country 128431 0
Australia
Phone 128431 0
+61 2 9065 9173
Fax 128431 0
Email 128431 0
[email protected]
Contact person for scientific queries
Name 128432 0
Deanna Francis
Address 128432 0
Black Dog Institute, Hospital Road, Randwick NSW 2031
Country 128432 0
Australia
Phone 128432 0
+61 2 9065 9173
Fax 128432 0
Email 128432 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?
All de-identified individual participant data will be shared through a secure global databank of child anxiety intervention data.
When will data be available (start and end dates)?
Data will be shared immediately following publication. There is no end date.
Available to whom?
It will be accessible to researchers wishing to access the global databank for conducting individual patient meta data analyses with aims of improving child anxiety treatment, and who get approval from the data custodian of this databank
Available for what types of analyses?
Individual Patient/Participant Data Meta-Analysis (IPDMAs)
How or where can data be obtained?
Access is through the secure cloud infrastructure ERICA, which has a UNSW instance. Access is subject to approval of the data custodian (Prof Jennie Hudson).

Contact details:
Prof Jennie Hudson
[email protected]
Black Dog Institute, Hospital Road, Prince of Wales Hospital, Randwick NSW 2031


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19860Study protocol  [email protected] TBC
19861Informed consent form  [email protected] TBC
19862Ethical approval  [email protected] TBC



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
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