ACTRN12626000918325进行中（未招募）不适用
A pilot randomised controlled trial evaluating the feasibility of a family-based lifestyle therapy program for reducing child anxiety: The CALM-Kids Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 48
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 6 Years 至 No limit（—）
- 性别
- All
入选标准
- •Children will be included if they:
- •Are aged 6-12 years at the time of consent. This will be determined by adult participant report during pre-screening or enrolment.
- •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.
- •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
- •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.
- •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.
- •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:
- •Are aged 18 years or older at the time of consent. This will be determined by self-report during pre-screening or enrolment.
- •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.
- •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
排除标准
- •Children participants will be excluded if they:
- •Are currently participating in another study that involves an intervention, as determined by adult participant self-report during pre-screening or enrolment.
- •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.
- •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.
- •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.
- •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.
- •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.
- •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.
- •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:
- •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.
- •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, diet
研究者
相似试验
进行中（未招募）
不适用
A pilot study comparing a co-designed patient information leaflet with a standard leaflet for care after a heart attackPost-myocardial infarction careCirculatory SystemISRCTN10966785University College Cork100
进行中（未招募）
不适用
A trial examining the feasibility, acceptability and efficacy of a psychologist-supported digital program for anxiety and risky drinking in mothersRisky drinkingMental Health - AddictionMental Health - AnxietyMental Health - DepressionAnxietyDepressionACTRN12626000834358The University of Sydney130
招募中
不适用
Phase 3 trial of VMX-C001 vs usual pharmacological care in patients taking a FXa direct oral anticoagulant who require urgent surgery with or without heparin. (EQUILIBRIX-S)jRCT2071260038800
招募中
1 期
A phase 1b trial to study the safety and effect of ZP9830 in patients with plaque psoriasisPlaque Psoriasis2026-525220-15-00Zealand Pharma A/S32
进行中（未招募）
1/2 期
Homoeopathy in renal calculiCTRI/2026/07/113461Sainath homoeopathic hospital35