- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06361147
Psychoeducation of Adult Siblings of ASD People (Autism Spectrum Disorder).
The Effect of Psychoeducation on Adult Siblings of People With Autism Spectrum Disorder.
The aim of this study is to evaluate the effectiveness of a psychoeducational program in enhancing autism-related knowledge, sibling relationships, well-being, and resilience among adults with a sibling on the spectrum, while also highlighting the need for tailored supportive interventions for this population.
The psychoeducational program will be implemented in adult siblings of people with ASD and its effectiveness will be assessed.
Participation in this program is expected to contribute in the improvement of the quality of life of the participants, their siblings with ASD and those related to them. No risk is identified.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Autism Spectrum Disorder (ASD) is a neurodevelopmental lifelong disorder of which prevalence has been significantly increased through the decades. Notwithstanding the abundant research finding on the ASD people and their parents regarding their mental health, quality of life etc., limited evidence exists regarding the siblings of people with ASD. The aim of this study is to apply a psychoeducational program for ASD in adult siblings of people with ASD as a means of providing disorder - related knowledge and improving their quality of life. The psychoeducational program will provide basic knowledge about ASD, training on behavioral management, acceptance and ongoing support to serve the needs of people with ASD and their caregivers.
This study will be a randomized controlled trial (RCT) with voluntary participation. The psychoeducational program will be implemented in adult siblings of people with ASD, free of charge, it will be conducted online by certified trainers, due to the coronavirus pandemic and its effectiveness will be assessed. The sample will be recruited from the general population of Greece. Four groups, each divided into experimental groups and control groups, will be randomized.
To evaluate the effectiveness of the program, participants will be asked to complete the online questionnaires three times (pre-intervention, post-intervention and three-month follow-up).
Participation in this program is expected to contribute in the improvement of the quality of life of the participants, their siblings with ASD and those related to them. No risk is identified.
This study is part of a doctoral thesis in progress at the Hellenic Mediterranean University (HELMEPA), Department of Social Work.
The study is expected to start in April 2024 and to be completed about six months later.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Crete
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Heraklion, Crete, Greece, 82102
- Hellenic Mediterranean University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion criteria were: (i) age 18 or older, (ii) having one sibling diagnosed with ASD, (iii) being neurotypical, and (iv) no prior participation in a psychoeducational program for autism.
Exclusion criteria were: (i) having more than one sibling diagnosed with ASD, and (ii) residing outside Greece.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Psychoeducational program (group A - Ex. gr)
This group of volunteers is going to participate in the online psychoeducational training program for ASD. Number of participants:11. To evaluate the effectiveness of the program, participants will be asked to complete the online questionnaires three times (pre-intervention, post-intervention and three-month follow-up). |
6 psychoeducation trainings for Autism Spectrum Disorder
|
|
No Intervention: Psychoeducational program (group A - Co. gr)
Concurrently with the experimental group A, the no-interventional group will be asked to complete the online questionnaires three times (pre-intervention, post-intervention and three-month follow-up).
Number of participants:11.
|
|
|
Experimental: Psychoeducational program (group Β - Ex. gr)
This group of volunteers is going to participate in the online psychoeducational training program for ASD. Number of participants:11. To evaluate the effectiveness of the program, participants will be asked to complete the online questionnaires three times (pre-intervention, post-intervention and three-month follow-up). |
6 psychoeducation trainings for Autism Spectrum Disorder
|
|
No Intervention: Psychoeducational program (group B - Co. gr)
Concurrently with the experimental group B, the no-interventional group will be asked to complete the online questionnaires three times (pre-intervention, post-intervention and three-month follow-up).
Number of participants:11.
|
|
|
Experimental: Psychoeducational program (group C - Ex. gr)
This group of volunteers is going to participate in the online psychoeducational training program for ASD. Number of participants:11. To evaluate the effectiveness of the program, participants will be asked to complete the online questionnaires three times (pre-intervention, post-intervention and three-month follow-up). |
6 psychoeducation trainings for Autism Spectrum Disorder
|
|
No Intervention: Psychoeducational program (group C - Co. gr)
Concurrently with the experimental group C, the no-interventional group will be asked to complete the online questionnaires three times (pre-intervention, post-intervention and three-month follow-up).
Number of participants:11.
|
|
|
Experimental: Psychoeducational program (group D - Ex. gr)
This group of volunteers is going to participate in the online psychoeducational training program for ASD. Number of participants:11. To evaluate the effectiveness of the program, participants will be asked to complete the online questionnaires three times (pre-intervention, post-intervention and three-month follow-up). |
6 psychoeducation trainings for Autism Spectrum Disorder
|
|
No Intervention: Psychoeducational program (group D - Co. gr)
Concurrently with the experimental group D, the no-interventional group will be asked to complete the online questionnaires three times (pre-intervention, post-intervention and three-month follow-up).
Number of participants:11.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Psychoeducation effectiveness on the knowledge of ASD
Time Frame: 6 months
|
The evaluation of psychoeducational program effect on knowledge of ASD is going to be evaluated throw the "Participatory Autism Knowledge Scale" questionnaire (29-item scale) will be used.
The original validation studies demonstrated satisfactory psychometric properties, showing good internal consistency.
The standardization and adaptation of the questionnaire into Greek has not yet been published in a peer-reviewed journal.
|
6 months
|
|
Psychoeducation effectiveness on siblings relationship
Time Frame: 6 months
|
A newly developed research measure, designed specifically for this study to assess negative emotions and attitudes of adult siblings toward their autistic sibling.
The questionnaire's name is "Adult Sibling Relationships and Autism Spectrum Questionnaire (ASRQ-AS) " - 31-item scale.
The standardization and adaptation of the questionnaire into Greek has not yet been published in a peer-reviewed journal.
|
6 months
|
|
Psychoeducation effectiveness on resilience of siblings of ASD
Time Frame: 6 months
|
The Brief Resilience Scale (BRS) was developed to assess an individual's ability to recover from stress and adversity.
It can also be used to examine factors and outcomes associated with resilience in both mental and physical health, identifying individuals who may benefit from supportive or therapeutic interventions.
The internal consistency (Cronbach's α) of the BRS demonstrates good reliability as well as in Greek version.
|
6 months
|
|
Psychoeducation effectiveness on the well-being of siblings of ASD
Time Frame: 6 months
|
The evaluation of psychoeducational program effect on the well-being is going to be evaluated throw the questionnaire "PERMA-Profiler" (23-item scale).
The scale has demonstrated adequate reliability and validity in assessing well-being - Cronbach's α values.
|
6 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: CHARALAMPOS DEPASTAS, PhD stud., Hellenic Mediterranean University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3764/2-10-2019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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