NCT06361147

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

March 28, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 11, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2024

Completed
Last Updated

November 14, 2025

Status Verified

November 1, 2025

Enrollment Period

7 months

First QC Date

March 28, 2024

Last Update Submit

November 13, 2025

Conditions

Keywords

psychoeducationsiblingssiblings relationshipASDAutism Spectrum Disorder

Outcome Measures

Primary Outcomes (4)

  • 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) 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

    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

    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

    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

Study Arms (8)

Psychoeducational program (group A - Ex. gr)

EXPERIMENTAL

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).

Other: Psychoeducational program for ASD

Psychoeducational program (group A - Co. gr)

NO INTERVENTION

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.

Psychoeducational program (group Β - Ex. gr)

EXPERIMENTAL

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).

Other: Psychoeducational program for ASD

Psychoeducational program (group B - Co. gr)

NO INTERVENTION

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.

Psychoeducational program (group C - Ex. gr)

EXPERIMENTAL

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).

Other: Psychoeducational program for ASD

Psychoeducational program (group C - Co. gr)

NO INTERVENTION

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.

Psychoeducational program (group D - Ex. gr)

EXPERIMENTAL

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).

Other: Psychoeducational program for ASD

Psychoeducational program (group D - Co. gr)

NO INTERVENTION

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.

Interventions

6 psychoeducation trainings for Autism Spectrum Disorder

Psychoeducational program (group A - Ex. gr)Psychoeducational program (group C - Ex. gr)Psychoeducational program (group D - Ex. gr)Psychoeducational program (group Β - Ex. gr)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hellenic Mediterranean University

Heraklion, Crete, 82102, Greece

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • CHARALAMPOS DEPASTAS, PhD stud.

    Hellenic Mediterranean University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Interventional groups and Control groups
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD candidate in Social Work

Study Record Dates

First Submitted

March 28, 2024

First Posted

April 11, 2024

Study Start

March 28, 2024

Primary Completion

October 30, 2024

Study Completion

October 30, 2024

Last Updated

November 14, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

We will keep the anonymity of participants and there is no plan to share their data to other researchers.

Locations