Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06427486
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-24
First Post:
2024-05-18
Brief Title:
Telecoaching Intervention for Children With Autism and Their Parents in Palestine
Sponsor:
Arab American University Palestine
Organization:
Arab American University Palestine
Study Overview
Official Title:
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 childrens skills and increase parents 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 childrens 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
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 childrens skills and increase parents 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 childrens 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
Detailed Description:
A purposive sampling technique will be used to recruit children with Autism Spectrum Disorder and their parentscaregivers 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 trials 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 11 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 childs 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 childs 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 childrens 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 13 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
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 11 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 childs 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 childs 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 childrens 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 13 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None