Dataset Information

Telehealth-delivered naturalistic developmental behavioural intervention with and without caregiver acceptance and commitment therapy for autistic children and their caregivers: protocol for a multi-arm parallel group randomised clinical trial.

ABSTRACT:

Introduction

Timely access to early support that optimises autistic children's development and their caregiver's mental health is critical. Naturalistic developmental behavioural interventions (NDBIs) and acceptance and commitment therapy (ACT) are evidence-based supports that can enhance child learning and behaviour, and adult well-being, respectively. The traditional face-to-face delivery of these approaches is resource intensive. Further, little is known about the benefit of parallel child-focused and caregiver-focused supports. The aims of this trial are to evaluate the effectiveness and social validity of telehealth-delivered, caregiver-implemented, child-focused NDBI and caregiver-focused ACT when delivered alone and in parallel, on autistic children's social communication and caregiver well-being.

Methods and analysis

The study will use a randomised, single-blind clinical trial with three parallel arms: NDBI; ACT and ACT+NDBI. We will recruit a minimum of 78, 2-5-year-old autistic children and their families throughout Aotearoa New Zealand. Support will be delivered over 13 weeks using a combination of culturally enhanced web-based modules and online group coaching. Primary outcome variables include children's social communication/engagement with their caregiver as well as caregiver stress and will be evaluated using a repeated measures multivariate analysis of variance. Outcome variables are assessed at baseline (before randomisation), immediately postparticipation and at 3-month follow-up.

Ethics and dissemination

The trial is approved by the Health and Disability Ethics Committee (2022 FULL 12058). The findings of this trial will be disseminated through peer-reviewed journals and national and international conference proceedings regardless of the magnitude/direction of effect. Additionally, data will be shared with stakeholder groups, service providers and health professionals.

Trial registration number

Australian New Zealand Clinical Trials Registry (ACTRN12622001134718).

SUBMITTER: McLay L

PROVIDER: S-EPMC10254711 | biostudies-literature | 2023 May

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Telehealth-delivered naturalistic developmental behavioural intervention with and without caregiver acceptance and commitment therapy for autistic children and their caregivers: protocol for a multi-arm parallel group randomised clinical trial.

McLay Laurie L Emerson Lisa Marie LM Waddington Hannah H van Deurs Jenna J Hunter Jolene J Blampied Neville N Hapuku Aaron A Macfarlane Sonja S Bowden Nicholas N van Noorden Lauren L Rispoli Mandy M

BMJ open 20230530 5

<h4>Introduction</h4>Timely access to early support that optimises autistic children's development and their caregiver's mental health is critical. Naturalistic developmental behavioural interventions (NDBIs) and acceptance and commitment therapy (ACT) are evidence-based supports that can enhance child learning and behaviour, and adult well-being, respectively. The traditional face-to-face delivery of these approaches is resource intensive. Further, little is known about the benefit of parallel ...[more]

PMID: 37253492

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Project description:BACKGROUND:Anxiety conditions are debilitating and prevalent throughout the world. Acceptance and Commitment Therapy (ACT) is an effective, acceptance-based behavioral therapy for anxiety. However, there are treatment barriers (eg, financial, geographical, and attitudinal), which prevent people from accessing it. To overcome these barriers, internet-delivered ACT (iACT) interventions have been developed in recent years. These interventions use websites to deliver ACT information and skill training exercises on the Web, either as pure self-help or with therapist guidance. OBJECTIVE:This systematic review aimed to examine the therapeutic impact of iACT on all anxiety conditions. METHODS:The EMBASE, MEDLINE, ProQuest Central, PsycINFO, Scopus, and Web of Science databases were searched up to September 2018. The titles and abstracts of remaining records after deduplication were screened by 2 authors with a total of 36 full-text articles being retained for closer inspection next to eligibility criteria. Empirical studies of all designs, population types, and comparator groups were included if they appraised the impact of iACT treatment on any standardized measure of anxiety. Included studies were appraised on methodological quality and had their data extracted into a standardized coding sheet. Findings were then tabulated, and a narrative synthesis was performed because of the heterogeneity found between studies. RESULTS:A total of 20 studies met inclusion criteria. There were 11 randomized controlled trials (RCTs) and 9 uncontrolled pilot studies. Participants across all studies were adults. The anxiety conditions treated were as follows: generalized anxiety disorder (GAD), social anxiety disorder (SAD), illness anxiety disorder (IAD), and general anxiety symptoms, with or without comorbid physical and mental health problems. A total of 18 studies reported significant anxiety reduction after iACT treatment. This was observed in studies that delivered iACT with (n=13) or without (n=5) therapist guidance. The average attrition rate across all included studies during the active iACT treatment phase was 19.19%. In the 13 studies that assessed treatment satisfaction, participants on average rated their iACT experience with above average to high treatment satisfaction. CONCLUSIONS:These findings indicate that iACT can be an efficacious and acceptable treatment for adults with GAD and general anxiety symptoms. More RCT studies are needed to corroborate these early iACT findings using empirical treatments in active control groups (eg, internet-delivered cognitive behavioral therapy). This would potentially validate the promising results found for SAD and IAD as well as address the full spectrum of anxiety disorders.

Project description:BackgroundMental health problems among adolescents are increasing, and internet-delivered acceptance and commitment therapy (iACT) constitutes a possible way to improve access to care while reducing costs. Nevertheless, few studies have investigated iACT for adolescents in regular primary care nor the role of parental support.ObjectiveThis is an exploratory evaluation investigating iACT, with or without parental support, for adolescents. The aims were to examine treatment adherence, symptoms of anxiety and depression, psychological flexibility, and overall functioning.MethodsAdolescents with anxiety were recruited within the regular primary care patient flow during the implementation phase of therapist-assisted iACT for adolescents. Assessment and inclusion were executed face-to-face. Due to organizational reasons, the assignment of treatment methods could not be randomized. Adherence was investigated by measuring the number of completed modules. Outcome measures were collected by self-assessment questionnaires including the Revised Children's Anxiety and Depression Scale and Avoidance and Fusion Questionnaire for Youth, as well as interviews using the Children's Global Assessment Scale. The analysis was performed as an exploratory evaluation using descriptive data for treatment adherence and nonparametric within-group analysis with the Wilcoxon signed rank test for related samples and treatment outcomes. This evaluation is naturalistic, and the results are preliminary and of a hypothesis-generating character and should be handled with caution.ResultsThe iACT group without parental support (n=9) exhibited a gradual dropout throughout the treatment period (n=5), whereas the iACT group with parental support (n=15) exhibited the lowest number of dropouts from treatment before completion (n=2), of which all occurred during the second half of treatment. The within-group, per-protocol analyses for the Revised Children's Anxiety and Depression Scale indicated reduced symptoms of anxiety and depression at the 12-month follow-up (z score: -2.94; P=.003; r=-0.6). The within-group, per-protocol analyses for the Avoidance and Fusion Questionnaire for Youth indicated increased psychological flexibility at the 12-month follow-up (z score: -2.54; P=.01; r=0.55). Nevertheless, no differences in overall functioning measured by the Children's Global Assessment Scale were found.ConclusionsThe results indicate that parental support might play a role in treatment adherence in iACT for adolescents with anxiety. Moreover, the outcome measures suggest that iACT for adolescents in primary care could constitute an effective treatment for both anxiety and depression, as indicated by the symptom reduction and increased psychological flexibility, maintained at the 12-month follow-up. Nevertheless, due to a small and gender-biased sample size with a large proportion of dropouts and missing data, a nonrandomized assignment of intervention, and an analysis limited to within group, this study should be considered an explorative evaluation rather than an outcome study.

Project description:BackgroundPeople who give care to autistic individuals (autism-caregivers) experience higher levels of caregiver strain than people who provide care for individuals with other chronic conditions (non-autism-caregivers). This places them at higher risk for psychological, behavioural and physical health concerns. The aim of this study is to delineate psychological, behavioural, and physical aspects of caregiver strain in autism-caregivers compared to non-autism-caregivers.MethodsWe included 3354 adult caregivers from the general population in the Netherlands participating in the second assessment (January, 1, 2014-December, 31, 2017) of the Lifelines Cohort. In this cohort study, using multivariable regression adjusted for age, sex, and socioeconomic status, we analysed psychological (anxiety and depression based on a Mini International Neuropsychiatric Interview, and self-reported stress and perceived health), behavioural (questionnaire-assessed physical activity, alcohol use, and smoking), and physical aspects (body mass index, waist circumference, and leukocyte-counts) of caregiver strain in autism-caregivers (n = 722) compared with non-autism-caregivers (n = 2632).FindingsAutism-caregivers reported more stress (OR 3.61, 95% CI 2.60-4.99). Both anxiety (OR 1.85, 95% CI 1.37-2.49) and depressive disorders (OR 1.83, 95% CI 1.17-2.86) were more common in autism-caregivers than in non-autism-caregivers. Perceived health, physical activity, alcohol use, and smoking were not different between autism- and non-autism-caregivers. In autism-caregivers, lymphocyte- and monocyte-counts were lower than in non-autism-caregivers.InterpretationIn this large cohort, autism-caregivers had worse psychological health than non-autism-caregivers. Moreover, autism-caregiving might be associated with an altered immune balance. These findings underline the higher caregiver strain in autism-caregivers compared to other caregivers. This calls for increased support to autism-caregivers.FundingLifelines has been funded by the Dutch government.

Project description:Internet-delivered interventions hold the possibility to make pain rehabilitation more accessible and adaptable by providing qualified individualized psychological care to chronic pain patients in their homes. Acceptance and commitment therapy (ACT) has shown promising results on psychological functioning and pain acceptance. Internet-delivered ACT (IACT) added to multimodal pain rehabilitation program (MMRP) in primary care has, so far, not shown better results than MMRP alone. The aim of this cluster randomized controlled study was to investigate the effects of adding IACT during and after MMRP in specialist care on psychological outcomes. In total, 122 patients who enrolled in a specialist pain clinic were cluster randomized groupwise to either MMRP (n = 12 groups) or to MMRP with added IACT (n = 12 groups). The IACT addition included 6 weeks of treatment during MMRP and 11 weeks of aftercare following MMRP. Online and paper-and-pencil self-report measures of pain acceptance, psychological inflexibility, self-efficacy, and psychosocial consequences of pain, were collected at four occasions: prior to and post MMRP, post aftercare intervention and at 1 year follow-up. Dropout was extensive with 25% dropping out at post treatment, an additional 35% at post aftercare, and 29% at 1 year follow-up. Medium treatment between-group effects were found on pain acceptance in favor of the group who received IACT added to MMRP, at post treatment and at post aftercare. Large effects were seen on psychological inflexibility and self-efficacy at post aftercare. A medium effect size was seen on affective distress at post aftercare. Moreover, a medium effect on self-efficacy was found at 1 year follow-up. The results indicate that IACT added during MMRP may enhance the treatment effects on pain-related psychological outcomes. Results also suggest that IACT as aftercare may strengthen the long-term effect of MMRP. However, adding a second pain treatment, IACT, to an already extensive pain treatment, MMRP, could be perceived as too comprehensive and might hence influence completion negatively. Further research on adverse events and negative effects could be helpful to improve adherence. Next step of implementation trials could focus on adding IACT before MMRP to improve psychological functioning and after MMRP to prolong its effect.

Project description:BACKGROUND:Severe health anxiety (hypochondriasis), or illness anxiety disorder according to the Diagnostic and Statistical Manual of Mental Disorders, 5th edition, is characterized by preoccupation with fear of suffering from a serious illness in spite of medical reassurance. It is a debilitating, prevalent disorder associated with increased health care utilization. Still, there is a lack of easily accessible specialized treatment for severe health anxiety. OBJECTIVE:The aims of this paper were to (1) describe the development and setup of a new internet-delivered acceptance and commitment therapy (iACT) program for patients with severe health anxiety using self-referral and a video-based assessment; and (2) examine the feasibility and potential clinical efficacy of iACT for severe health anxiety. METHODS:Self-referred patients (N=15) with severe health anxiety were diagnostically assessed by a video-based interview. They received 7 sessions of clinician-supported iACT comprising self-help texts, video clips, audio files, and worksheets over 12 weeks. Self-report questionnaires were obtained at baseline, post-treatment, and at 3-month follow-up. The primary outcome was Whiteley-7 Index (WI-7) measuring health anxiety severity. Depressive symptoms, health-related quality of life (HRQoL), life satisfaction, and psychological flexibility were also assessed. A within-group design was employed. Means, standard deviations, and effect sizes using the standardized response mean (SRM) were estimated. Post-treatment interviews were conducted to evaluate the patient experience of the usability and acceptability of the treatment setup and program. RESULTS:The self-referral and video-based assessments were well received. Most patients (12/15, 80%) completed the treatment, and only 1 (1/15, 7%) dropped out. Post-treatment (14/15, 93%) and 3-month follow-up (12/15, 80%) data were available for almost all patients. Paired t tests showed significant improvements on all outcome measures both at post-treatment and 3-month follow-up, except on one physical component subscale of HRQoL. Health anxiety symptoms decreased with 33.9 points at 3-month follow-up (95% CI 13.6-54.3, t11= 3.66, P=.004) with a large within-group effect size of 1.06 as measured by the SRM. CONCLUSIONS:Treatment adherence and potential efficacy suggest that iACT may be a feasible treatment for health anxiety. The uncontrolled design and small sample size of the study limited the robustness of the findings. Therefore, the findings should be replicated in a randomized controlled trial. Potentially, iACT may increase availability and accessibility of specialized treatment for health anxiety. TRIAL REGISTRATION:Danish Data Protection Agency, Central Denmark Region: 1-16-02-427-14; https://www.rm.dk/sundhed/faginfo/forskning/datatilsynet/ (Archived by Webcite at http://www.webcitation.org/6yDA7WovM).

Dataset Information

Telehealth-delivered naturalistic developmental behavioural intervention with and without caregiver acceptance and commitment therapy for autistic children and their caregivers: protocol for a multi-arm parallel group randomised clinical trial.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

Telehealth-delivered naturalistic developmental behavioural intervention with and without caregiver acceptance and commitment therapy for autistic children and their caregivers: protocol for a multi-arm parallel group randomised clinical trial.

Similar Datasets

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