Acceptability, Feasibility, and Potential Impact of a Telecoaching Intervention for Parents of Children With Autism Spectrum Disorder in Palestine: A Mixed-Methods Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Canadian Occupational Performance Measure
研究概览
简要总结
Families of children with autism in Palestine may have difficulty accessing early intervention and rehabilitation services because specialized services are limited and families may face geographical, financial, and other barriers. Providing support to parents remotely may help families access professional guidance without needing to travel for every session.
This pilot study examined whether an eight-week parent telecoaching program called Occupational Performance Coaching (OPC) could be delivered successfully and was acceptable to parents of young children with autism in Palestine. The study also explored changes in children's participation in everyday activities and autism-related characteristics, as well as parents' confidence in supporting their child and their quality of life. Because this was a small pilot study, these outcomes were explored to help plan future research rather than to determine whether the intervention was effective.
Parents were assigned to one of two groups. Parents in the telecoaching group received eight individual online coaching sessions over eight weeks, with each session lasting approximately 40-60 minutes. Coaching helped parents identify activities that were important to their child and family, understand difficulties affecting the child's participation, develop possible strategies, try these strategies during everyday routines, and review progress with the coach.
Parents in the waitlist group had access to general Arabic-language information and videos about autism through the Sanad Alhayaa digital platform during the eight-week comparison period but did not receive individual coaching. After completing the post-intervention assessment, they were offered the telecoaching program.
The study also included interviews with parents who received telecoaching to better understand their experiences, perceived benefits, and barriers to using this form of support.
详细描述
This study used an explanatory sequential mixed-methods design. The quantitative component was a two-arm, parallel-group external pilot randomized controlled trial evaluating an eight-week telehealth-delivered Occupational Performance Coaching (OPC) intervention for parents of children with autism in Palestine. The study primarily evaluated the feasibility of trial procedures and intervention delivery and the acceptability of telecoaching. Child and parent outcomes were examined exploratorily to characterize patterns and variability of change and to inform the design of a future definitive trial.
Parents and their children were recruited from West Bank districts through community-based and online recruitment approaches. Eligible parents or primary caregivers were aged 18 years or older, spent the majority of the intervention period with the child, and had access to an internet-enabled device and reliable internet connection. Eligible children were aged 3-7 years and had a confirmed diagnosis of autism spectrum disorder from a neurologist or psychiatrist. Children receiving other early-intervention or rehabilitation services remained eligible.
Following informed consent and completion of baseline assessments, 26 parent-child dyads were randomized, with 14 allocated to OPC telecoaching and 12 to the waitlist control condition. Allocation was conducted using covariate-adaptive minimization based on the Pocock-Simon approach, with a random component, to reduce imbalance between groups with respect to child sex and baseline CARS-2 autism severity. Randomization was centrally controlled by an independent coordinator who was not involved in recruitment, baseline assessment, intervention delivery, or outcome analysis. Participants and the intervention provider could not be masked because of the nature of the coaching intervention.
Participants allocated to the intervention received eight weekly individualized OPC sessions delivered synchronously through Zoom, with sessions lasting approximately 40-60 minutes. Coaching focused on parent-selected occupational performance goals and supported parents to analyze performance challenges, generate possible solutions, implement strategies within everyday routines, and review progress. The Sanad Alhayaa digital platform supported intervention-related procedures, including appointment booking, questionnaires, individualized resources, and intervention documentation. During the randomized comparison period, participants allocated to the waitlist condition had access to general Arabic-language autism-related resources through Sanad Alhayaa but did not receive individualized OPC. They were offered OPC telecoaching after completing the post-intervention assessment.
Feasibility was evaluated using prespecified progression criteria addressing recruitment, digital platform procedures, randomization, retention, questionnaire completion, intervention attendance, intervention fidelity, and safety. Telecoaching acceptability was assessed using the Saudi Telehealth Acceptance Scale. Exploratory child outcomes included individualized occupational performance and satisfaction measured using the Canadian Occupational Performance Measure, autism-related characteristics measured using the Autism Treatment Evaluation Checklist and Childhood Autism Rating Scale, Second Edition, and parent outcomes assessing parental competence and quality of life.
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
- Single (Outcomes Assessor)
盲法说明
Participants and the intervention provider could not be masked because the intervention required direct participation in individualized coaching sessions. Allocation was centrally controlled by an independent coordinator, and the intervention provider had no access to forthcoming allocations before assignment. CARS-2 assessments were conducted by an independent occupational therapist who was not involved in intervention delivery and was blinded to group allocation. COPM was administered independently to OPC participants for individualized goal identification and intervention planning and was not treated as a blinded comparative outcome.
入排标准
- 年龄范围
- 3 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parent or primary caregiver aged ≥18 years and able to provide informed consent.
- •Parent or caregiver spends the majority of the intervention period with the child.
- •Access to an internet-enabled device capable of videoconferencing and a reliable internet connection.
- •Child aged 3-7 years with a confirmed diagnosis of autism spectrum disorder by a neurologist or psychiatrist.
- •Children receiving other early-intervention or rehabilitation services remained eligible to participate.
排除标准
- •Parent or caregiver unable to meet the above participation requirements.
- •Child with a co-occurring medical, neurological, or genetic condition requiring intensive medical or pharmacological management beyond the scope of the intervention, such as uncontrolled epilepsy or a complex genetic syndrome.
结局指标
主要结局
Canadian Occupational Performance Measure
时间窗: Baseline, pre-intervention
is used to help parents identify and prioritize the goals they want their child to achieve in the domains of self-care, productivity, and leisure. The tool involves parents rating each identified goal on a scale of 1 to 10, with 1 indicating that the goal is not important and 10 indicating that it is extremely important. From the list of identified goals, parents select the top five that they want to work on during the intervention. Parents then rate their child's performance and their satisfaction with that performance on a scale of 1 to 10, with 1 indicating that they are not satisfied and 10 indicating that they are extremely satisfied. This helps to measure changes in parents' perception of their child's performance and their satisfaction with that change from pre-test to post-test. The COPM has demonstrated sound psychometric properties with parents of children with disabilities, including construct validity and criterion validity.
Percentage of Recruitment Target Achieved
时间窗: During the recruitment period
Recruitment was assessed as the percentage of the prespecified recruitment target achieved during the planned recruitment period. The prespecified progression criterion was recruitment of 30 parent-child dyads within four weeks.
Percentage of Participants Successfully Completing Required Digital Platform Procedures
时间窗: From enrollment through post-intervention assessment (approximately 8 weeks)
Digital platform feasibility was assessed as the percentage of participants who successfully completed the required Sanad Alhayaa platform procedures, including account creation and child-profile registration. The prespecified progression criterion was successful completion of the required platform procedures by at least 80% of participants.
Percentage of Participants Successfully Randomized According to the Prespecified Procedure
时间窗: Immediately after baseline assessment
Randomization feasibility was assessed as the percentage of randomized participants allocated according to the prespecified randomization procedure without allocation errors or major protocol deviations. The prespecified progression criterion was successful allocation of all randomized participants without errors or major deviations.
Percentage of Participants Completing Required Online Study Questionnaires
时间窗: At baseline and post-intervention (approximately 8 weeks)
Questionnaire completion was assessed as the percentage of participants who completed the required online study questionnaires at baseline and post-intervention. The prespecified progression criterion was questionnaire completion by at least 80% of participants at each assessment point.
Percentage of Randomized Participants Completing Post-Intervention Assessment
时间窗: From randomization through post-intervention assessment (approximately 8 weeks)
Participant retention was assessed as the percentage of randomized participants who completed the post-intervention assessment. The prespecified progression criterion was retention of at least 80% of randomized participants.
Percentage of Intervention Participants Attending at Least 7 of 8 OPC Sessions
时间窗: During the 8-week OPC intervention period
Intervention attendance was assessed as the percentage of intervention participants who attended at least seven of the eight planned OPC telecoaching sessions. The prespecified progression criterion was attendance at a minimum of seven of eight sessions.
OPC Fidelity Measure: Percentage of Prescribed Components Demonstrated
时间窗: During the 8-week OPC intervention period
Intervention fidelity was assessed using the OPC Fidelity Measure in independently audited OPC sessions. Fidelity was calculated as the percentage of prescribed OPC components demonstrated during each audited session. The prespecified progression criterion was fidelity of at least 80%.
Number of Serious Adverse Events Attributable to Study Participation
时间窗: From enrollment through post-intervention assessment (approximately 8 weeks)
Safety was assessed as the number of serious adverse events considered attributable to study participation. The prespecified progression criterion was no serious adverse events attributable to study participation.
Mean Saudi Telehealth Acceptance Scale (STAS) Score
时间窗: Baseline and post-intervention (8 weeks)
The STAS is a 24-item Arabic-language measure of telehealth acceptance covering Performance Expectancy, Effort Expectancy, Social Influence, Facilitating Conditions, and Behavioral Intention. Items are rated from 1 (strongly disagree) to 5 (strongly agree), with higher scores indicating greater acceptance of telehealth. Domain and overall scores were assessed at baseline and post-intervention.
次要结局
- Parental Competence Scale for Children with Autism Spectrum Disorder(Baseline, pre-intervention)
- Autism Treatment Evaluation Checklist (ATEC)(Baseline, pre-intervention)
- The 36-Item Short Form Health Survey questionnaire (SF-36)(Baseline, pre-intervention)
- Canadian Occupational Performance Measure(Baseline and post-intervention (8 weeks))
- Autism Treatment Evaluation Checklist (ATEC)(Baseline and post-intervention (8 weeks))
- Childhood Autism Rating Scale, Second Edition (CARS-2)(Baseline and post-intervention (8 weeks))
- Parental Competence Scale for Children with Autism Spectrum Disorder(Baseline and post-intervention (8 weeks))
- World Health Organization Quality of Life, Brief Version (WHOQOL-BREF)(Baseline and post-intervention (8 weeks))
- Arabic Quality of Life in Autism (A-QoLA)(Baseline and post-intervention (8 weeks))
研究者
Mohammad Salahat
Instructor/ Head of Speech, Language, and Hearing Disorders Department
Arab American University (Palestine)