Autism Spectrum DisorderNCT06427486
Telecoaching Intervention for Children With Autism and Their Parents in Palestine
A study testing Occupational Performance Coaching (OPC) Telecoaching and General Sanad Alhayaa Digital Resources in people with Autism Spectrum Disorder, run by Arab American University (Palestine) at 1 site in Palestinian Territories.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 3 to 7 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Occupational Performance Coaching (OPC) Telecoaching and General Sanad Alhayaa Digital Resources
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 sitePalestinian Territories
- Study dates
- 15 Feb 2025to 21 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Occupational Performance Coaching (OPC) Telecoaching, General Sanad Alhayaa Digital Resources
- Keywords
- telecoaching, Telehealth, Early intervention, Quality of life, parent's self-competency, Activities of daily living, occupational performance coaching
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occupational Performance Coaching (OPC) TelecoachingOther
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 ResourcesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| OPC Telecoaching | Experimental | Participants allocated to this arm received an eight-week individualized Occupational Performance Coaching (OPC) intervention delivered remotely through Zoom and supported by the Sanad Alhayaa digital platform. Receives: Other: Occupational Performance Coaching (OPC) Telecoaching |
| Waitlist Control: General Digital Resources | Other | During the eight-week randomized comparison period, participants allocated to this arm had access to general autism-related resources through the Sanad Alhayaa digital platform but did not receive individualized OPC. After completing the post-intervention assessment, they were offered the OPC telecoaching intervention. Receives: Other: General Sanad Alhayaa Digital Resources |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Recruitment Target Achieved
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.
Measured: During the recruitment period
Percentage of Participants Successfully Completing Required Digital Platform Procedures
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.
Measured: From enrollment through post-intervention assessment (approximately 8 weeks)
Percentage of Participants Successfully Randomized According to the Prespecified Procedure
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.
Measured: Immediately after baseline assessment
Percentage of Participants Completing Required Online Study Questionnaires
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.
Measured: At baseline and post-intervention (approximately 8 weeks)
Percentage of Randomized Participants Completing Post-Intervention Assessment
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.
Measured: From randomization through post-intervention assessment (approximately 8 weeks)
Percentage of Intervention Participants Attending at Least 7 of 8 OPC Sessions
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.
Measured: During the 8-week OPC intervention period
OPC Fidelity Measure: Percentage of Prescribed Components Demonstrated
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%.
Measured: During the 8-week OPC intervention period
Number of Serious Adverse Events Attributable to Study Participation
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.
Measured: From enrollment through post-intervention assessment (approximately 8 weeks)
Mean Saudi Telehealth Acceptance Scale (STAS) Score
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.
Measured: Baseline and post-intervention (8 weeks)
Secondary outcomes (6)
Canadian Occupational Performance Measure
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.
Measured: Baseline and post-intervention (8 weeks)
Autism Treatment Evaluation Checklist (ATEC)
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.
Measured: Baseline and post-intervention (8 weeks)
Childhood Autism Rating Scale, Second Edition (CARS-2)
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.
Measured: Baseline and post-intervention (8 weeks)
Parental Competence Scale for Children with Autism Spectrum Disorder
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.
Measured: Baseline and post-intervention (8 weeks)
World Health Organization Quality of Life, Brief Version (WHOQOL-BREF)
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.
Measured: Baseline and post-intervention (8 weeks)
Arabic Quality of Life in Autism (A-QoLA)
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.
Measured: Baseline and post-intervention (8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2024
- Study start15 Feb 2025
- Primary completion21 Jun 2025
- Study completion21 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study used an explanatory sequential mixed-methods design. The quantitative component was a two-arm, parallel-group external pilot randomized controlled trial comparing an eight-week telehealth-delivered Occupational Performance Coaching intervention with a waitlist control condition. Participants allocated to the waitlist condition received the telecoaching intervention after completing the randomized post-intervention assessment. Following the intervention, semi-structured interviews were conducted with intervention participants to explore their experiences and perceptions of telecoaching. The quantitative component evaluated feasibility, acceptability, and exploratory child and parent outcomes, while the qualitative component was used to provide additional understanding of participants' experiences and the implementation of the intervention.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arab American University (Palestine)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad Salahat, Arab American University (Palestine)
- Investigators
- Mohammad Salahat, PhD, Principal investigator, Arab American University (Palestine)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06427486
- Sponsor's protocol ID
- Parent Telecoaching and ASD
- Status last verified
- Aug 2026
- First submitted
- 18 May 2024
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made publicly available because the study involved a small sample of parent-child dyads from a defined population and the consent process did not include public sharing of individual-level participant data. De-identified aggregate study findings will be reported in scientific publications.
Publications
Aschbrenner KA, Kruse G, Gallo JJ, Plano Clark VL. Applying mixed methods to pilot feasibility studies to inform intervention trials. Pilot Feasibility Stud. 2022 Sep 26;8(1):217. doi: 10.1186/s40814-022-01178-x.
PubMed 36163045Dunn W, Little LM, Pope E, Wallisch A. Establishing Fidelity of Occupational Performance Coaching. OTJR (Thorofare N J). 2018 Apr;38(2):96-104. doi: 10.1177/1539449217724755. Epub 2017 Aug 18.
PubMed 28821218Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA; PAFS consensus group. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. Pilot Feasibility Stud. 2016 Oct 21;2:64. doi: 10.1186/s40814-016-0105-8. eCollection 2016.
PubMed 27965879Little LM, Pope E, Wallisch A, Dunn W. Occupation-Based Coaching by Means of Telehealth for Families of Young Children With Autism Spectrum Disorder. Am J Occup Ther. 2018 Mar/Apr;72(2):7202205020p1-7202205020p7. doi: 10.5014/ajot.2018.024786.
PubMed 29426380
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06427486
- Acronym / sponsor ID
- Parent Telecoaching and ASD
- Conditions
- Autism Spectrum Disorder
- Keywords
- telecoaching, Telehealth, Early intervention, Quality of life, parent's self-competency, Activities of daily living, occupational performance coaching
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Arab American University (Palestine)University, hospital or other
- Study start
- 15 Feb 2025 (actual)
- Primary completion
- 21 Jun 2025 (actual)
- Study completion
- 21 Jun 2025 (actual)
- First posted
- 24 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study used an explanatory sequential mixed-methods design. The quantitative component was a two-arm, parallel-group external pilot randomized controlled trial comparing an eight-week telehealth-delivered Occupational Performance Coaching intervention with a waitlist control condition. Participants allocated to the waitlist condition received the telecoaching intervention after completing the randomized post-intervention assessment. Following the intervention, semi-structured interviews were conducted with intervention participants to explore their experiences and perceptions of telecoaching. The quantitative component evaluated feasibility, acceptability, and exploratory child and parent outcomes, while the qualitative component was used to provide additional understanding of participants' experiences and the implementation of the intervention.
| Arm | Type | Receives |
|---|---|---|
| OPC Telecoaching | Experimental | Other: Occupational Performance Coaching (OPC) TelecoachingParticipants allocated to this arm received an eight-week individualized Occupational Performance Coaching (OPC) intervention delivered remotely through Zoom and supported by the Sanad Alhayaa digital platform. |
| Waitlist Control: General Digital Resources | Other | Other: General Sanad Alhayaa Digital ResourcesDuring the eight-week randomized comparison period, participants allocated to this arm had access to general autism-related resources through the Sanad Alhayaa digital platform but did not receive individualized OPC. After completing the post-intervention assessment, they were offered the OPC telecoaching intervention. |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Occupational Performance Coaching (OPC) TelecoachingOccupational 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. | Other | OPC Telecoaching |
| General Sanad Alhayaa Digital ResourcesGeneral 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. | Other | Waitlist Control: General Digital Resources |
Primary outcome
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.
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.
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.
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.
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.
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.
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%.
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.
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.
6 secondary outcomes
Canadian Occupational Performance Measure
Time frame: Baseline and post-intervention (8 weeks)
Autism Treatment Evaluation Checklist (ATEC)
Time frame: Baseline and post-intervention (8 weeks)
Childhood Autism Rating Scale, Second Edition (CARS-2)
Time frame: Baseline and post-intervention (8 weeks)
Parental Competence Scale for Children with Autism Spectrum Disorder
Time frame: Baseline and post-intervention (8 weeks)
World Health Organization Quality of Life, Brief Version (WHOQOL-BREF)
Time frame: Baseline and post-intervention (8 weeks)
Arabic Quality of Life in Autism (A-QoLA)
Time frame: Baseline and post-intervention (8 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Background: PubMed 36163045Aschbrenner KA, Kruse G, Gallo JJ, Plano Clark VL. Applying mixed methods to pilot feasibility studies to inform intervention trials. Pilot Feasibility Stud. 2022 Sep 26;8(1):217. doi: 10.1186/s40814-022-01178-x.
- Background: PubMed 28821218Dunn W, Little LM, Pope E, Wallisch A. Establishing Fidelity of Occupational Performance Coaching. OTJR (Thorofare N J). 2018 Apr;38(2):96-104. doi: 10.1177/1539449217724755. Epub 2017 Aug 18.
- Background: PubMed 27965879Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA; PAFS consensus group. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. Pilot Feasibility Stud. 2016 Oct 21;2:64. doi: 10.1186/s40814-016-0105-8. eCollection 2016.
- Background: PubMed 29426380Little LM, Pope E, Wallisch A, Dunn W. Occupation-Based Coaching by Means of Telehealth for Families of Young Children With Autism Spectrum Disorder. Am J Occup Ther. 2018 Mar/Apr;72(2):7202205020p1-7202205020p7. doi: 10.5014/ajot.2018.024786.
- Individual participant dataSharing planned: No. Individual participant data will not be made publicly available because the study involved a small sample of parent-child dyads from a defined population and the consent process did not include public sharing of individual-level participant data. De-identified aggregate study findings will be reported in scientific publications.
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Sensory-integration Therapy Verses Augumented Reality-based Training in ASD
Autism Spectrum Disorder
Recruiting
Cumulative and Booster Effects of Multisession Prefrontal tDCS in ASD Adolescents
Transcranial Direct Current Stimulation, Autistic Spectrum Disorder
Not yet recruiting
"Family Resilience And Mind-body Enhancement" (FRAME): A Randomised Controlled Trial
Autism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammad Salahat, PhD principal investigator
Arab American University (Palestine)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Occupational Performance Coaching (OPC) Telecoaching and General Sanad Alhayaa Digital Resources in people with Autism Spectrum Disorder, run by Arab American University (Palestine) at 1 site in Palestinian Territories.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Palestinian Territories. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Recruitment Target Achieved (time frame: During the recruitment period). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06427486, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.