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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06361147
Other study ID # 3764/2-10-2019
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date March 28, 2024
Est. completion date October 2024

Study information

Verified date April 2024
Source Hellenic Mediterranean University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to apply a psychoeducational program in adult siblings of people with ASD as a means to provide knowledge related to the disorder and improving their quality of life. The psycho-educational 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.


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 psycho-educational 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 (before the psychoeducation, after completion and three months later). 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 88
Est. completion date October 2024
Est. primary completion date July 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - Adults - Have a brother or a sister diagnosed with ASD Exclusion Criteria: - Underage - No sibling with ASD - Have two or more siblings with ASD - Have already been trained to "Cygnet" psychoeducational program.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Cygnet program for ASD
6 psychoeducation trainings for Autism Spectrum Disorder

Locations

Country Name City State
Greece Hellenic Mediterranean University Heraklion Crete

Sponsors (1)

Lead Sponsor Collaborator
Hellenic Mediterranean University

Country where clinical trial is conducted

Greece, 

Outcome

Type Measure Description Time frame Safety issue
Primary Psychoeducation effectiveness on siblings of ASD The impact of the psychoeducational program "Cygnet" adapted to the needs of adults who have a sibling with ASD will be evaluated. The impact of the program is to be evaluated throw questionnaires: a) in terms of knowledge about ASD, b) Siblings Relationship, c) Well-being and d) Resilience. 6 months
Primary Psychoeducation effectiveness on the knowledge of ASD 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) by Gillespie-Lynch et al. (2021) will be used. 6 months
Primary Psychoeducation effectiveness on siblings relationship The evaluation of psychoeducational program effect on siblings relationship is going to be evaluated throw new questionnaire based on Birtchnell's theory for relationship, constructed by the PhD candidate. The questionnaire's name is "Person's Relating to Siblings (PRS-ASD)" - 40-item scale (Cronbach Alpha = 0,79). 6 months
Primary Psychoeducation effectiveness on resilience of siblings of ASD The evaluation of psychoeducational program effect on resilience is going to be evaluated throw the questionnaire "CD-RISC" (6-item scale) conducted by Smith Smith et al. (2008). 6 months
Primary Psychoeducation effectiveness on the well-being of siblings of ASD The evaluation of psychoeducational program effect on the well-being is going to be evaluated throw the questionnaire "PERMA-Profiler" (23-item scale) conducted by Butler & Kern (2016) based on Seligman's theory. 6 months
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