None listed
Conditions
Brief summary
The purpose of this study is to determine whether it is feasible and acceptable to deliver the CALM-Kids program online and to explore its potential to improve anxiety symptoms and healthy lifestyle behaviours in children. The findings will help inform the design of a larger clinical trial. This study is a pilot randomised controlled trial comparing the CALM-Kids lifestyle program with a befriending program delivered via telehealth. Families will be randomly allocated to one of the two programs. Both programs include one individual online session followed by seven weekly small-group online sessions involving the child and a carer, delivered by trained facilitators via Zoom for Education. The CALM-Kids program is a family-based lifestyle intervention designed to support children experiencing anxiety. It focuses on everyday lifestyle habits, including physical activity, healthy eating, sleep, and screen time, using practical activities, goal setting, and parent/carer support to help families make sustainable behaviour changes. The befriending program is a structured group program that provides the same amount of facilitator contact and group interaction but does not include therapeutic or lifestyle advice. Instead, it focuses on social activities and conversation.
Interventions
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 care
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.
Sponsors
Deakin University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
6 Years to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed