Telecoaching Intervention for Children With Autism and Their Parents in Palestine

May 23, 2024 updated by: Mohammad Salahat, Arab American University (Palestine)

Investigating the Potential Efficacy, Feasibility, and Acceptability of Parent Telecoaching Intervention on Children With Autism and Their Parents in Palestine: A Mixed-Method Pilot Randomized Controlled Trial

In Palestine, children with autism spectrum disorder and their parents face difficulties in receiving needed early intervention and rehabilitation services due to a lack of specialized professionals and centers, as well as cultural, political, geographical, and financial barriers. Parents also face difficulties in raising their children with autism in their homes as they lack knowledge about the disorder and the best interventions that can be used to help these children.

Parent telecoaching intervention, or what is called (distance coaching via technology) can help parents and their children with autism. However, no research exists studying the possibility of using this intervention with parents and their children in Palestine and if it can have positive results on both parents and children.

The goal of this trial is to learn if parent telecoaching intervention is feasible and acceptable to parents of children with autism in Palestine. It will also learn if this intervention has the potential to improve children's skills and increase parent's self-competency and quality of life. The main questions it aims to answer are:

  • To what extent and in what ways is providing telecoaching intervention for parents of children with Autism in Palestine possible?
  • How do parents see telecoaching intervention in terms of suitability, benefits, facilitators, and barriers?
  • Does telecoaching intervention for parents have the potential to increase children's participation in daily activities that parents consider important?
  • Does telecoaching intervention have the potential to enhance parents' self-competence and family quality of life? Researchers will compare parent telecoaching intervention to a web-based resource designed to provide parents with general information about autism to see if parent telecoaching intervention works to help children with autism and their parents more than the free autism resources provided on the website.

Participants will:

  • Take a telecoaching intervention (eight sessions over eight weeks, each session lasts one hour) or use the information provided on the website about autism.
  • Apply the planned strategies with their children during the week and record their work using videos or by filling out a form to be reviewed at the beginning of each session.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

A purposive sampling technique will be used to recruit children with Autism Spectrum Disorder and their parents/caregivers who live in the West Bank districts. Two recruitment strategies will be used to invite participants from various districts in the West Bank. The first will involve approaching a third party, the Superhero Autism Foundation, to distribute invitation packages to potential eligible participants based on the provided inclusion and exclusion criteria. This foundation has been chosen as it has access to a vast dataset of children with autism across the West Bank. The second strategy will involve advertising flyers on social media and patient organization websites. Those who wish to participate will be asked to send their signed reply slip form to the trial's author using the contact information provided (email or WhatsApp). After that, they will be contacted by phone to screen their eligibility. Parents who meet the eligibility criteria will be informed that an initial meeting with each one of them will be conducted to explain the purpose of the trial further, check their willingness to be randomized, answer any questions they may have, confirm their consent to participate, agree on the first assessment meeting date and time which will be done before randomization, and discuss the schedule of the subsequent telecoaching sessions.

Sample size: A pilot randomized trial typically does not require a sample power calculation. However, as a rule of thumb, at least 30 participants will be needed for a pilot Randomized Controlled Trial. To address a potential attrition rate of 10%, 40 parent-child dyads (20 in each group) will be recruited.

Randomisation: The study will employ a stratified block randomization method to assign parents to either the telecoaching intervention group or the waitlist control group in a 1:1 ratio. Once baseline assessments are completed with eligible participants who have consented to participate, a screening number will be allocated to each parent, and the child's autism symptoms score will be recorded. This score will be categorized as <60 or ≥60 using the Autism Treatment Evaluation Checklist. The assigned screening number and the child's autism severity score for each participant will then be sent to a non-study member, a lecturer in the Occupational Therapy Department, who will conduct the allocation and randomization process based on predetermined block sizes of four using a computer-generated random sequence. Stratification will be conducted based on autism severity categorized as <60 or ≥60. This method is chosen to ensure an equal distribution of participants in each group and to minimize the impact of children's autism severity. The trial author responsible for enrolling participants will not have access to the concealed random allocation sequence. However, due to the nature of the intervention, blinding the treatment assigned to participants will not be feasible. All data from randomized participants will be recorded in a Case Report Form (CRF). Participants will be informed of the randomization outcome via phone contact.

Quantitative Data Analysis:

The Statistical Package for the Social Sciences (SPSS) version 26 will be used to conduct all statistical analyses.

Descriptive statistics will be used to analyze the following:

  • Feasibility Criterions (1,3, 4, 6): eligibility, retention, provider intervention fidelity, and adverse event (if it occurs).
  • Participants' demographic data will be analysed using percentages, mean, and standard deviation).
  • The commonalities among family-specified goals on the Canadian Occupational Performance Measure (COPM).

Inferential statistics (Potential efficacy of Parent telecoaching intervention):

A t-test will be used to examine changes in means from pre-to-post-tests (between and within groups).

Qualitative Analysis (Acceptability, benefits, facilitators and barriers):

The recorded interviews will be analyzed using six iterative steps: (1) familiarization, (2) initial coding, (3) theme identification, (4) theme review, (5) theme definition and naming, and (6) report production. The trial author and a colleague will review and create initial codes, revisit the full transcriptions, and search for themes using the codes. They will meet multiple times to ensure theme names accurately describe the reports.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Parents are the primary caregivers spending most of the intervention period with their child
  • Parents are at least 18 years old and able to provide informed consent
  • Parents have access to mobile devices such as phones, tablets or computers with Zoom software and a stable internet connection
  • The children are between the ages of 3 and 6 years old and have a confirmed ASD diagnosis from a psychiatrist or pediatrician.
  • Children with ASD and other comorbid conditions are also eligible to participate.

Exclusion Criteria:

  • Adolescents and older adults with ASD.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Parent Telecoaching Intervention
The telecoaching intervention will consist of eight weekly sessions, lasting between 40 minutes to one hour each, conducted through Zoom. Before the sessions begin, an initial assessment meeting will take place with each parent. The sessions will follow the occupational performance coaching (OPC) processes, which aim to enhance parents' problem-solving skills and promote children's participation. These processes include the Connect, Structure, and Share stages, focusing on active listening, goal-setting, and information exchange between the provider and the parent. A Casenote template will be used to organize these sessions.
Other: Parents Telecoaching Intervention
- Synchronous (Zoom platform) and Asynchronous coaching sessions for parents of children with autism.
No Intervention: Access to a web-based (sanadmed).
The Waitlist Control Group Intervention will have access to a web-based Autism resources called "Sanad Al-Haya". This resource provides general information and videos on Autism and how to manage specific needs such as sensory issues, social interaction, and activities of daily living. The resources are developed by the trial author in Arabic language. All participants are required to register on the Sanad platform and create an account in their child's name. If they wish, the waitlist control group will have the option to take parent telecoaching sessions after the intervention group has completed all sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Canadian Occupational Performance Measure
Time Frame: 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.
Baseline, pre-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The 36-Item Short Form Health Survey questionnaire (SF-36)
Time Frame: Baseline, pre-intervention
is used to evaluate the quality of life of parents using a 36-item Likert-type scale that measures eight domains (general health, physical role limitation, role limitation arising from emotional issues, physical functioning, vitality, mental health, bodily pain, and social function). The SF-36 questionnaire provides scores ranging from 0 to 100, with higher scores indicating better QoL. The questionnaire has been translated into Arabic, culturally validated, and utilized in research aimed at investigating the QoL of parents of children who have autism.
Baseline, pre-intervention
Parental Competence Scale for Children with Autism Spectrum Disorder
Time Frame: Baseline, pre-intervention
This is a 29-item Arabic scale that measures parental competence for children with ASD. Each item has a 5-point rating scale. The scale is used to rate statements based on whether parents agree or disagree with them. A score of 5 is given to "Strongly Agree," while a score of 1 is given to "Strongly Disagree" for positive statements. For negative statements, the score is reversed. The minimum score is 29, while the maximum is 145. The validity of the tool was ensured by specialized staff in education psychology, and the reliability of the tool was tested demonstrating acceptable value (Cronbach Alpha 0.89).
Baseline, pre-intervention
Autism Treatment Evaluation Checklist (ATEC)
Time Frame: Baseline, pre-intervention
This tool is used to identify the severity of autism and assess the effectiveness of interventions and treatments. It comprises of 77 questions that are divided into four categories: speech/language/communication (14 questions), sociability (20 questions), sensory/cognitive awareness (18 questions), and health/physical/behavior (25 questions). Parents or caregivers are responsible for completing the checklist, and lower scores indicate milder symptoms. The ATEC has been translated into Arabic and validated, revealing good internal consistency (a= 0.84), content validity (90% among referees), and construct validity
Baseline, pre-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arab American University (Palestine)

Investigators

  • Principal Investigator: Mohammad Salahat, PhD, Arab American University (Palestine)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2024

Primary Completion (Estimated)

March 2, 2025

Study Completion (Estimated)

March 30, 2025

Study Registration Dates

First Submitted

May 18, 2024

First Submitted That Met QC Criteria

May 23, 2024

First Posted (Actual)

May 24, 2024

Study Record Updates

Last Update Posted (Actual)

May 24, 2024

Last Update Submitted That Met QC Criteria

May 23, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Parent Telecoaching and ASD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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