Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000918325
Ethics application status
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Approved
Date submitted
Help: Date submitted
23/06/2026
Date registered
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27/07/2026
Date last updated
Help: Date last updated
27/07/2026
Date data sharing statement initially provided
Help: Data sharing statement date
27/07/2026
Type of registration
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Prospectively registered

Titles & IDs
Public title
A pilot randomised controlled trial evaluating the feasibility of a family-based lifestyle therapy program for reducing child anxiety: The CALM-Kids Study
Scientific title
A pilot randomised controlled trial evaluating the feasibility of a family-based lifestyle therapy program for reducing child anxiety: The CALM-Kids Study
Additional trial identifiers [1] 317496 0
[email protected]
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Clinical anxiety 342214 0
Subclinical anxiety 342862 0
Condition category
Condition code
Mental Health 338329 338329 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
The lifestyle intervention is a transdiagnostic, child-centred, and family-based lifestyle program designed to support children with anxiety by targeting modifiable lifestyle behaviours that influence anxiety symptoms and daily functioning.

The 8-week program comprises an initial one-on-one 60-minute introductory session followed by seven weekly 60-minute group sessions. All sessions are attended by both the child and their carer, excluding the first group session which will be attended by cares only.
All sessions will be delivered via telehealth using the Zoom for Education enterprise version produced by Zoom Video Communications. Group sessions will comprise a minimum of 2 and a maximum of six child-parent/carer dyads, allowing opportunities for interaction while maintaining an appropriate facilitator-to-participant ratio.

The intervention focuses on three core lifestyle domains: physical activity, nutrition, and sleep. Recreational screen time will be addressed indirectly through these domains by promoting behaviours that naturally reduce opportunities for recreational screen use, such as increasing participation in physical activity, protecting family mealtimes from device use, and establishing consistent, screen-free bedtime routines. Sessions include direct child engagement alongside parent/carer-focused components to support the child's goals, preferences, and developmental needs. Children are supported to gradually increase moderate-to-vigorous physical activity (including age-appropriate resistance and bone-strengthening activities), adopt healthy eating patterns based on the best available evidence for mental health and the Australian Dietary Guidelines, establish consistent sleep routines with calming pre-bedtime practices, and develop balanced recreational screen time habits. Carers play an active role by modelling healthy behaviours, providing scaffolding and reinforcement, and creating supportive home environments to enable behaviour change.

In line with evidence-based best practice, CALM-Kids will be, a) co-facilitated by two practitioners who have either experience working with children and families or in lifestyle interventions (e.g., nutrition, exercise, sleep) or both, and supervised by accredited health professionals with expertise in the relevant domain (e.g., accredited dietitian, accredited exercise physiologist/physical educator, registered psychologist) to support safe, consistent, and high-quality delivery; and b) use evidence-based behaviour change approaches, including motivational interviewing, goal setting and self-monitoring.

Adherence to the intervention will be monitored through session attendance records maintained by facilitators, completion of between-session activities and goal-setting tasks, and facilitator checklists documenting delivery of core intervention components to support intervention fidelity.
Intervention code [1] 334285 0
Lifestyle
Description of the comparator or control
The comparator arm will receive a manualised befriending intervention adapted from established befriending protocols used in psychotherapy trials and informed through co-design with children and their carers. Befriending is a structured, non-specific intervention designed to control for common therapeutic factors, including time, attention, expectancy, and therapeutic alliance, without introducing active therapeutic components. The inclusion of a befriending condition enables isolation of the specific effects of the CALM-Kids intervention by ensuring that both trial arms receive equivalent contact time, group interaction, and facilitator support.

The 8-week program comprises an initial one-on-one 60-minute introductory session followed by seven weekly 60-minute group sessions. All sessions are attended by both the child and their carer, excluding the first group session which will be attended by cares only.
All sessions will be delivered via telehealth using the Zoom for Education enterprise version produced by Zoom Video Communications. Group sessions will comprise a minimum of 2 and a maximum of six child-parent/carer dyads, allowing opportunities for interaction while maintaining an appropriate facilitator-to-participant ratio.

The intervention will be delivered by trained facilitators with experience working with children and families in educational, health or community settings. Facilitators will receive specific training in befriending principles and rationale, and maintaining neutrality and avoiding therapeutic drift.

The befriending intervention is designed to provide a warm, engaging, and socially supportive environment without delivering active therapeutic content. Sessions focus on enjoyable, everyday topics (e.g., hobbies, pets, games, holidays, favourite foods, or interests) and interactive group activities that encourage conversation and social connection. Facilitators adopt a warm, non-directive style while avoiding therapeutic techniques, including psychoeducation, cognitive or behavioural strategies, lifestyle or health behaviour change advice, problem-solving, or discussion of anxiety symptoms and emotional distress.

Adherence to the intervention will be monitored through session attendance records maintained by facilitators and facilitator checklists documenting delivery of the manualised befriending content to support intervention fidelity.
Control group
Active

Outcomes
Primary outcome [1] 345656 0
Recruitment ease
Timepoint [1] 345656 0
post-completion of intervention
Primary outcome [2] 345657 0
Retention
Timepoint [2] 345657 0
post-completion of intervention
Primary outcome [3] 345658 0
Adherence
Timepoint [3] 345658 0
post-completion of intervention
Secondary outcome [1] 462707 0
Data completeness
Timepoint [1] 462707 0
post-completion of intervention
Secondary outcome [2] 462708 0
Child Anxiety
Timepoint [2] 462708 0
Baseline, post-completion of intervention
Secondary outcome [3] 462709 0
Child Depression
Timepoint [3] 462709 0
Baseline, post-completion of intervention
Secondary outcome [4] 462710 0
Child Functioning
Timepoint [4] 462710 0
Baseline, post-completion of intervention
Secondary outcome [5] 462711 0
Child Self-Efficacy
Timepoint [5] 462711 0
Baseline, post-completion of intervention
Secondary outcome [6] 462712 0
Child Physical activity - subjective
Timepoint [6] 462712 0
Baseline, post-completion of intervention
Secondary outcome [7] 462713 0
Child Physical activity - objective
Timepoint [7] 462713 0
Baseline, post-completion of intervention
Secondary outcome [8] 462714 0
Child Diet
Timepoint [8] 462714 0
Baseline, post-completion of intervention
Secondary outcome [9] 462715 0
Child Sleep - subjective
Timepoint [9] 462715 0
Baseline, post-completion of intervention
Secondary outcome [10] 462716 0
Child Sleep - Objective
Timepoint [10] 462716 0
Baseline, post-completion of intervention
Secondary outcome [11] 462717 0
Child Screen time
Timepoint [11] 462717 0
Baseline, post-completion of intervention
Secondary outcome [12] 462718 0
Child School attendance
Timepoint [12] 462718 0
Baseline, post-completion of intervention
Secondary outcome [13] 462719 0
Child’s daily routine
Timepoint [13] 462719 0
Baseline, post-completion of intervention
Secondary outcome [14] 462724 0
Child Healthcare service use
Timepoint [14] 462724 0
Baseline, post-completion of intervention
Secondary outcome [15] 462726 0
Overall psychological distress
Timepoint [15] 462726 0
Baseline, post-completion of intervention
Secondary outcome [16] 462727 0
Adult quality of life
Timepoint [16] 462727 0
Baseline, post-completion of intervention
Secondary outcome [17] 462728 0
Adult impacts on work productivity
Timepoint [17] 462728 0
Baseline, post-completion of intervention
Secondary outcome [18] 462729 0
Adult self-efficacy
Timepoint [18] 462729 0
Baseline, post-completion of intervention
Secondary outcome [19] 462730 0
Adult physical activity - subjective
Timepoint [19] 462730 0
Baseline, post-completion of intervention
Secondary outcome [20] 462731 0
Adult physical activity - objective
Timepoint [20] 462731 0
Baseline, post-completion of intervention
Secondary outcome [21] 462732 0
Adult diet
Timepoint [21] 462732 0
Baseline, post-completion of intervention
Secondary outcome [22] 462733 0
Adult sleep - subjective
Timepoint [22] 462733 0
Baseline, post-completion of intervention
Secondary outcome [23] 462734 0
Adult sleep - objective
Timepoint [23] 462734 0
Baseline, post-completion of intervention
Secondary outcome [24] 462736 0
Economic evaluation
Timepoint [24] 462736 0
Baseline, post-completion of intervention
Secondary outcome [25] 462737 0
Feasibility
Timepoint [25] 462737 0
post-completion of intervention
Secondary outcome [26] 462738 0
Acceptability
Timepoint [26] 462738 0
post-completion of intervention
Secondary outcome [27] 462739 0
Intervention Appropriateness
Timepoint [27] 462739 0
post-completion of intervention
Secondary outcome [28] 462740 0
Intervention adaptations and modifications
Timepoint [28] 462740 0
post-completion of intervention
Secondary outcome [29] 462741 0
Intervention acceptability and appropriateness
Timepoint [29] 462741 0
post-completion of intervention
Secondary outcome [30] 462742 0
Treatment expectancy
Timepoint [30] 462742 0
Baseline, 4-weeks post-commencement of intervention, and post-completion of intervention
Secondary outcome [31] 465057 0
Health-related quality of life
Timepoint [31] 465057 0
Baseline, post-completion of intervention
Secondary outcome [32] 465080 0
Adult Depression
Timepoint [32] 465080 0
Baseline, post-completion of intervention
Secondary outcome [33] 465081 0
Adult Anxiety
Timepoint [33] 465081 0
Baseline, post-completion of intervention
Secondary outcome [34] 465084 0
Adult Stress
Timepoint [34] 465084 0
Baseline, post-completion of intervention

Eligibility
Key inclusion criteria
Children will be included if they:
1. Are aged 6-12 years at the time of consent. This will be determined by adult participant report during pre-screening or enrolment.
2. Are residing in Victoria, Australia, and are expected to remain in Victoria for the duration of the intervention and follow-up period. This will be determined by adult participant report during pre-screening or enrolment.
3. Have clinical or subclinical anxiety symptoms as determined by the Anxiety Disorders Interview Schedule for DSM-5, Child and Parent Versions (ADIS-5-C/P) administered by an appropriately trained assessor. Children will be eligible where the ADIS-5-C/P indicates either:
a) Clinical anxiety:
i. Full DSM-5 criteria for at least one primary anxiety disorder (e.g. separation anxiety disorder, generalized anxiety disorder, social anxiety disorder, specific phobia, panic disorder, agoraphobia, selective mutism), and
ii. Clinician Severity Rating (CSR) greater than or equal to 4 for the primary anxiety diagnosis
OR
b) Subclinical anxiety:
i. Does not reach full diagnostic threshold (e.g. just below symptom or duration criterion or CSR < 4), but
ii. Presents with clinically elevated anxiety symptoms above developmental expectations and at least mild functional interference (e.g. CSR equal to 3 on any anxiety diagnosis or clear symptom related interference noted in the ADIS-5-C/P).
This criterion will be determined by the trained assessor following completion of the ADIS-5-C/P with the child participant and adult participant. Where diagnostic status, symptom severity, or functional interference is unclear, the case will be reviewed by the Principal Investigator or an appropriately qualified clinical member of the research team.
4. Have the capacity to understand and demonstrate willingness to engage in the study intervention and assessments in English, either verbally or through alternative or augmentative communication methods, such as AAC devices. Child participants may also attend with an adult participant who can support communication and engagement where required. This will be determined during the consent/assent, enrolment, and orientation processes, based on the child participant’s demonstrated understanding of study participation, willingness to take part, communication needs, and ability to engage with reasonable support.
5. Have an eligible adult participant who is willing and able to participate in the study alongside the child. This includes providing informed consent, supporting the child’s participation, and completing adult participant study procedures, as determined through adult participant screening, enrolment, and informed consent processes.

Adult participants (parents or legal guardian) will be included if they:
1. Are aged 18 years or older at the time of consent. This will be determined by self-report during pre-screening or enrolment.
2. Are residing in Victoria, Australia, and are expected to remain in Victoria for the duration of the intervention and follow-up period. This will be determined by self-report during pre-screening or enrolment.
3. Are the parent or legal guardian of the participating child and have the capacity and legal authority to provide informed consent for the child’s participation in the study. This will be determined through self-report during screening and confirmed prior to consent by verbal confirmation of the child participant’s and adult participant’s full names, confirmation of the parent/guardian relationship, and visual inspection of a government-issued identification document.
4. Have capacity to provide informed consent for their own participation in the study. This will be determined by the consenting researcher during the informed consent process, including the adult participant’s demonstrated understanding of the study purpose, procedures, risks, benefits, confidentiality, and voluntary nature of participation.
5. Are able to speak and understand English sufficiently to complete study procedures, including questionnaires, interviews, safety monitoring, and group-based online sessions. This will be determined by self-report and assessed during pre-screening, enrolment, and consent discussions.
6. Have basic computer and internet literacy sufficient to join and participate in online study procedures, including opening links, accessing REDCap surveys, using videoconferencing software, and troubleshooting simple connection issues with virtual support from study staff. This will be determined by self-report during pre-screening or enrolment and may be further assessed during orientation or early study contact if required.
7. Are able to attend and actively participate in all scheduled weekly group-based online sessions together with the child over the 8-week intervention period; and commit to being the sole, consistent attending caregiver for the duration of the intervention (i.e. the attending caregiver cannot alternate or be substituted by another parent/carer during the intervention period). This will be determined by self-report during enrolment, including discussion of availability, expected attendance, and participation requirements.

Adult participants (parent or legal guardian): Eligible adult participants will be aged 18 years or older, reside in Victoria, Australia, and be the parent or legal guardian of the participating child participant. Adults must have the capacity and legal authority to provide informed consent for the child and for their own participation, be able to communicate in English, and possess sufficient computer and internet literacy to participate in online study procedures. They must also be willing and able to attend and actively participate in all scheduled online group sessions with their child over the 8-week intervention period as the child's sole consistent attending caregiver.
Minimum age
6 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Children participants will be excluded if they:
1. Are currently participating in another study that involves an intervention, as determined by adult participant self-report during pre-screening or enrolment.
2. Have severe food allergies, intolerances, aversions, malabsorption issues, or other nutrition-related conditions requiring specialist or highly individualised dietary management, where participation in the CALM-Kids group-based nutrition component would be contraindicated, unsafe, or clinically inappropriate. This will be determined by adult participant self-report, with review by an appropriately qualified member of the research or clinical team where required.
3. Have a medical condition, injury, disability, or physical limitation requiring specialist or highly individualised physical activity management, where participation in the CALM-Kids group-based movement component would be contraindicated, unsafe, or clinically inappropriate. This will be determined by adult participant self-report, medical history, medical advice, or clinical review where required.
4. Have a known or suspected clinically unstable systemic medical disorder that would make participation in the CALM-Kids group-based lifestyle intervention contraindicated, unsafe, or clinically inappropriate. This will be determined by adult participant self-report, medical history, current treatment status, medical advice, or clinical review where required.
5. Have current or past eating disorder pathology, including ARFID, or clinically significant restrictive, avoidant, weight/shape-related, or nutritionally concerning eating behaviours that may require specialist individual assessment or intervention, as determined through adult participant-reported pre-screening and/or investigator judgement.
6. Have received treatment for an acute or severe mental health concern requiring inpatient admission or emergency department presentation within the past 30 days, including but not limited to suicidality, severe depressive state, psychosis, mania, or other acute psychiatric deterioration. This will be determined by adult participant self-report during pre-screening or enrolment.
7. Have commenced or substantially changed mental health treatment within the past 30 days, where the investigator determines this would create safety concerns or substantially confound interpretation of trial outcomes.
8. Are unable to engage meaningfully in a group-based telehealth format, despite reasonable caregiver support and adjustments, where this would prevent safe or appropriate participation in the intervention or trial procedures. This will be determined during enrolment, consent, orientation, or early trial contact based on communication, behavioural, practical, safety, privacy, or support needs.

Adult participants will be excluded if they:
1. Have a medical condition, injury, disability, or physical limitation requiring specialist or highly individualised physical activity management, where participation in the CALM-Kids group-based movement component would be contraindicated, unsafe, or clinically inappropriate. This will be determined by self-report, medical history, medical advice, or clinical review where required.
2. Are pregnant, breastfeeding, or planning pregnancy during the intervention period, or planning pregnancy within six months after completing the intervention, as participation in the group-based lifestyle intervention may require individualised medical, dietary, or physical activity advice beyond the scope of CALM-Kids. Eligibility will be determined by self-report during pre-screening or enrolment.
3. Have a known or suspected clinically unstable systemic medical disorder that would make participation in the CALM-Kids group-based lifestyle intervention contraindicated, unsafe, or clinically inappropriate. This will be determined by self-report, medical history, current treatment status, medical advice, or clinical review where required.
4. Have current or past eating disorder diagnosis or treatment, or screening responses indicating clinically significant eating disorder symptoms or eating-related concerns requiring specialist individual intervention. This will be determined through self-report, pre-screening questions, and the Sick, Control, One, Fat, Food (SCOFF) questionnaire. Participants who report current or past eating disorder diagnosis or treatment, or who score 3 or above on the SCOFF, will be excluded.
5. Have received treatment for an acute or severe mental health concern requiring inpatient admission or emergency department presentation within the past 30 days, including but not limited to suicidality, severe depressive state, mania, psychosis, or other acute psychiatric deterioration. This will be determined by self-report during pre-screening or enrolment.
6. Are unable to engage meaningfully in a group-based telehealth format, despite reasonable adjustments, where this would prevent safe or appropriate participation in the intervention or trial procedures. This will be determined during enrolment, consent, orientation, or early trial contact based on communication, behavioural, practical, safety, privacy, or support needs.

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)
Baseline and post intervention follow-up data will be collected via online video conferencing by an RA who is blinded to intervention allocation. Baseline assessments will be conducted prior to participant randomisation and commencement to either program. Participants will also be asked not to reveal the condition to which they have been assigned during the post intervention follow-up assessment. The RA will remain blinded until the end of the 8-week post intervention follow-up interview, where the participant will be asked for feedback on the program they were allocated to.

Statistical analyses will be performed by a biostatistician from the research team, who will be blinded to treatment allocation. Expectation bias, the effect of the intervention is overestimated due to participants’ expectation of outcome, is one of the most difficult methodological challenges in behavioural research, where blinding participants’ condition (i.e. lifestyle recommendations) is usually not possible. Cognisant of this issue, the language in advertising and the Participant Information and Consent Form has been framed as if we are comparing the feasibility and effectiveness of two programs for reducing anxiety, and participants will be blind to the hypothesised superiority of the lifestyle program. This was done so as not to bias participants' expectations before entering the study, and to reduce the likelihood that participants will drop out if they are allocated to their non-preferred group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation to the intervention arm will be achieved using computer-generated block randomisation in a 1:1 ratio (intervention to control). The allocation sequence will be generated by a third-party statistician, independent of the research team.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2026
Actual
Date of last participant enrolment
Anticipated
3/05/2027
Actual
Date of last data collection
Anticipated
30/06/2027
Actual
Sample size
Target
48
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 322062 0
Government body
Name [1] 322062 0
National Health and Medical Research Council’s (NHMRC) Medical Research Future Fund 2024 Childhood Mental Health Research
Country [1] 322062 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
Country
Australia
Secondary sponsor category [1] 324945 0
None
Name [1] 324945 0
Address [1] 324945 0
Country [1] 324945 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320591 0
Deakin University Human Research Ethics Committee (DUHREC)
Ethics committee address [1] 320591 0
Ethics committee country [1] 320591 0
Australia
Date submitted for ethics approval [1] 320591 0
02/06/2026
Approval date [1] 320591 0
21/07/2026
Ethics approval number [1] 320591 0

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

Contacts
Principal investigator
Name 150990 0
A/Prof Lisa Olive
Address 150990 0
Deakin University, 221 Burwood Highway, Burwood, Victoria, Australia 3125
Country 150990 0
Australia
Phone 150990 0
+61 3 9246 8553
Fax 150990 0
Email 150990 0
[email protected]
Contact person for public queries
Name 150991 0
Karyn Richardson
Address 150991 0
Deakin University, 221 Burwood Highway, Burwood, Victoria, Australia 3125
Country 150991 0
Australia
Phone 150991 0
+61392517431
Fax 150991 0
Email 150991 0
[email protected]
Contact person for scientific queries
Name 150992 0
A/Prof Lisa Olive
Address 150992 0
Deakin University, 221 Burwood Highway, Burwood, Victoria, Australia 3125
Country 150992 0
Australia
Phone 150992 0
+61 3 9246 8553
Fax 150992 0
Email 150992 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.