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Completed

NCT Number: NCT06427486

Telecoaching Intervention for Children With Autism and Their Parents in Palestine

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.

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Key information

Age range

3 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arab American University

Jenin, Palestinian Territories

About this study

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.

Quantitative analyses emphasized descriptive feasibility estimates and exploratory estimation of change rather than confirmatory hypothesis testing. Continuous outcomes were summarized descriptively, and exploratory within-group and between-group changes were accompanied by confidence intervals and standardized effect-size estimates where appropriate. The small pilot sample and exploratory nature of these analyses were considered when interpreting the findings.

Following the intervention, semi-structured interviews were conducted with intervention participants to explore their experiences and perceptions of telecoaching, including acceptability, perceived benefits, facilitators, barriers, and implementation experiences. The qualitative component was intended to provide contextual understanding of the quantitative findings and the implementation of the intervention.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Occupational Performance Coaching (OPC) Telecoaching

Other

Occupational Performance Coaching (OPC) is a collaborative, occupation-focused coaching approach that supports parents to identify meaningful participation goals, analyze occupational performance challenges, generate possible solutions, implement strategies within everyday routines, and review progress. In this study, OPC was delivered individually through eight weekly 40-60 minute Zoom sessions. Sanad Alhayaa supported appointment booking, electronic questionnaires, secure individualized resources, and intervention documentation.

General Sanad Alhayaa Digital Resources

Other

General Arabic-language information and videos addressing autism, sensory needs, social interaction, and activities of daily living were made available through the Sanad Alhayaa resource library. This resource access did not include individualized coaching, individualized resource uploads, private clinical messaging, or coaching-session booking.

Primary outcomes

  1. Percentage of Recruitment Target Achieved

    Time frame: 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.

  2. Percentage of Participants Successfully Completing Required Digital Platform Procedures

    Time frame: 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.

  3. Percentage of Participants Successfully Randomized According to the Prespecified Procedure

    Time frame: 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.

  4. Percentage of Participants Completing Required Online Study Questionnaires

    Time frame: 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.

  5. Percentage of Randomized Participants Completing Post-Intervention Assessment

    Time frame: 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.

  6. Percentage of Intervention Participants Attending at Least 7 of 8 OPC Sessions

    Time frame: 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.

  7. OPC Fidelity Measure: Percentage of Prescribed Components Demonstrated

    Time frame: 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%.

  8. Number of Serious Adverse Events Attributable to Study Participation

    Time frame: 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.

  9. Mean Saudi Telehealth Acceptance Scale (STAS) Score

    Time frame: 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.

Secondary outcomes

  1. Canadian Occupational Performance Measure

    Time frame: Baseline and post-intervention (8 weeks)

    The COPM is an individualized, occupation-focused measure in which parents identify and prioritize occupational performance goals for their child. For prioritized goals, parents rate perceived performance and satisfaction with performance separately on 10-point scales ranging from 1 to 10, with higher scores indicating better perceived performance or greater satisfaction. Mean Performance and Satisfaction scores were calculated separately and change was assessed from baseline to post-intervention. The COPM was administered only to participants allocated to OPC because it formed part of individualized goal identification and intervention planning.

  2. Autism Treatment Evaluation Checklist (ATEC)

    Time frame: Baseline and post-intervention (8 weeks)

    The ATEC is a 77-item parent-report measure comprising four domains: Speech/Language/Communication, Sociability, Sensory/Cognitive Awareness, and Health/Physical/Behavior. Domain scores and the total score were calculated separately. Total scores range from 0 to 179, with lower scores indicating fewer autism-related difficulties. Change in domain and total scores was assessed from baseline to post-intervention.

  3. Childhood Autism Rating Scale, Second Edition (CARS-2)

    Time frame: Baseline and post-intervention (8 weeks)

    The CARS-2 is a clinician-rated measure of autism-related characteristics comprising 15 items rated from 1 to 4. Item ratings are summed to produce a total score ranging from 15 to 60, with higher scores indicating greater severity of autism-related characteristics. Change in total score was assessed from baseline to post-intervention.

  4. Parental Competence Scale for Children with Autism Spectrum Disorder

    Time frame: Baseline and post-intervention (8 weeks)

    The PCS-ASD is a 29-item Arabic-language measure of parental competence. Items are rated on a 5-point Likert scale, with negatively worded items reverse scored. Total scores range from 29 to 145, with higher scores indicating greater perceived parental competence. Change in total score was assessed from baseline to post-intervention.

  5. World Health Organization Quality of Life, Brief Version (WHOQOL-BREF)

    Time frame: Baseline and post-intervention (8 weeks)

    The WHOQOL-BREF is a 26-item measure of quality of life covering four domains: Physical Health, Psychological, Social Relationships, and Environment, together with two global items. Items are rated on 5-point response scales. Domain scores are calculated according to WHO scoring guidance, with higher scores indicating better quality of life. Change in domain scores was assessed from baseline to post-intervention.

  6. Arabic Quality of Life in Autism (A-QoLA)

    Time frame: Baseline and post-intervention (8 weeks)

    The A-QoLA is an autism-specific parent-reported quality-of-life measure comprising two separately scored parts. Part A assesses parents' general quality of life, with higher scores indicating better quality of life. Part B assesses the perceived impact of the child's autism-related difficulties on the parent, with higher scores indicating that parents are less affected by those difficulties. Part A and Part B were scored and interpreted separately. Change in each part was assessed from baseline to post-intervention.

Sponsors and collaborators

Lead sponsor

Arab American University (Palestine)

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 24, 2024
Registry last updated
Aug 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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