NCT06427486

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 24, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2025

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2025

Completed
Last Updated

May 24, 2024

Status Verified

May 1, 2024

Enrollment Period

6 months

First QC Date

May 18, 2024

Last Update Submit

May 23, 2024

Conditions

Keywords

telecoachingTelehealthEarly interventionQuality of lifeparent's self-competencyActivities of daily livingoccupational performance coaching

Outcome Measures

Primary Outcomes (1)

  • Canadian Occupational Performance Measure

    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 Outcomes (3)

  • The 36-Item Short Form Health Survey questionnaire (SF-36)

    Baseline, pre-intervention

  • Parental Competence Scale for Children with Autism Spectrum Disorder

    Baseline, pre-intervention

  • Autism Treatment Evaluation Checklist (ATEC)

    Baseline, pre-intervention

Study Arms (2)

Parent Telecoaching Intervention

EXPERIMENTAL

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

Access to a web-based (sanadmed).

NO INTERVENTION

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.

Interventions

\- Synchronous (Zoom platform) and Asynchronous coaching sessions for parents of children with autism.

Parent Telecoaching Intervention

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Adolescents and older adults with ASD.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • 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.

    PMID: 36163045BACKGROUND
  • Dahl-Popolizio S, Carpenter H, Coronado M, Popolizio NJ, Swanson C. Telehealth for the Provision of Occupational Therapy: Reflections on Experiences During the COVID-19 Pandemic. Int J Telerehabil. 2020 Dec 8;12(2):77-92. doi: 10.5195/ijt.2020.6328.

    PMID: 33520097BACKGROUND
  • Dunn 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.

    PMID: 28821218BACKGROUND
  • Efird J. Blocked randomization with randomly selected block sizes. Int J Environ Res Public Health. 2011 Jan;8(1):15-20. doi: 10.3390/ijerph8010015. Epub 2010 Dec 23.

    PMID: 21318011BACKGROUND
  • Eldridge 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.

    PMID: 27965879BACKGROUND
  • Little 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.

    PMID: 29426380BACKGROUND
  • Whitehead AL, Julious SA, Cooper CL, Campbell MJ. Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat Methods Med Res. 2016 Jun;25(3):1057-73. doi: 10.1177/0962280215588241. Epub 2015 Jun 19.

    PMID: 26092476BACKGROUND
  • Yazdani S, Capuano A, Ghaziuddin M, Colombi C. Exclusion Criteria Used in Early Behavioral Intervention Studies for Young Children with Autism Spectrum Disorder. Brain Sci. 2020 Feb 13;10(2):99. doi: 10.3390/brainsci10020099.

    PMID: 32069875BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Mohammad Salahat, PhD

    Arab American University (Palestine)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hisham A Arabkabeya, Asst. Prof.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a mixed-method pilot randomized waitlist-controlled trial with two parallel groups: the telecoaching intervention group and the waitlist control group, and semi-structured interviews with intervention participants. The utilization of a waitlist control group enables the comparison of the potential effects of the intervention group with those of a control group while ensuring that parents in the wait-listed control group can have access to telecoaching intervention after the completion of the study. After completing telecoaching sessions, participants from the intervention group will be invited to participate in semi-structured interviews to explore their perceptions about the intervention. The reason for using a mixed method is to achieve a comprehensive understanding of telecoaching intervention (its feasibility, acceptability, and potential efficacy) and to explain findings by connecting information obtained from both designs.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Instructor/ Head of Speech, Language, and Hearing Disorders Department

Study Record Dates

First Submitted

May 18, 2024

First Posted

May 24, 2024

Study Start

September 1, 2024

Primary Completion

March 2, 2025

Study Completion

March 30, 2025

Last Updated

May 24, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share