Autism Spectrum DisorderNCT06361147
Psychoeducation for Adult Siblings of ASD People (Autism Spectrum Disorder).
A study testing Psychoeducational program for ASD in people with Autism Spectrum Disorder and Sibling Relations, run by Hellenic Mediterranean University at 1 site in Greece.
Trial summary
The purpose of this study was to evaluate the effectiveness of a novel psychoeducational program for adult siblings of autistic individuals, aiming to improve autism-related knowledge, well-being, resilience and sibling relationship outcomes, while also highlighting the need for tailored supportive interventions for… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder, Sibling Relations
- What is being tested?
- Psychoeducational program for ASD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteGreece
- Study dates
- 28 Mar 2024to 30 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Inclusion criteria were: (i) age 18 or older, (ii) having one sibling with a clinical diagnosis of ASD, (iii) no self-reported neurodevelopmental diagnosis, (iv) no prior participation in a psychoeducational program for autism and v) able to understand and communicate in Greek.
Exclusion criteria were: (i) having more than one sibling diagnosed with ASD, and (ii) residing outside Greece.
Participants were also required to have access to the internet and a device capable of participating in the online audiovisual sessions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Psychoeducation on Adult Siblings of People With Autism Spectrum Disorder.
The purpose of this study was to evaluate the effectiveness of a novel psychoeducational program for adult siblings of autistic individuals, aiming to improve autism-related knowledge, well-being, resilience and sibling relationship outcomes, 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.
We expect that after the intervention, participants in the intervention group will demonstrate improvements in the study outcomes compared with participants in the control group, and that some of these improvements will be maintained at the three-month follow-up. We further expect that the participants' level of caregiving involvement with their autistic sibling will be associated with the effectiveness of the intervention. No risk is identified.
Read the detailed description
Autism Spectrum Disorder (ASD) is a neurodevelopmental lifelong disorder of which prevalence has been significantly increased through the decades.
As a result, the rise in autism prevalence has been accompanied by a parallel increase in the number of individuals who have autistic siblings, a group estimated to number in the millions.
Although supportive interventions have demonstrated benefits for family members, existing research has primarily focused on autistic individuals and their parents. Consequently, evidence regarding interventions specifically designed for adult siblings remains limited.
The purpose of this study was to evaluate the effectiveness of a novel psychoeducational program for adult siblings of autistic individuals, aiming to improve autism-related knowledge, well-being, resilience and sibling relationship outcomes, while also highlighting the need for tailored supportive interventions for this population. The psychoeducational program aims to enhance understanding of autism, encourage emotional expression and a sense of belonging, improve family and sibling communication, and provide practical strategies for everyday challenges.
A parallel-group randomized controlled trial with assessments at baseline, post-intervention and three-month follow-up will be conducted among adult siblings of autistic individuals across Greece (voluntary participation). Participants will be randomly allocated (1:1) to the intervention or control group. The intervention comprise six free-of-charge online psychoeducational sessions and one follow-up session and will be delivered by two social workers certified in autism psychoeducation, whereas the control group will complete questionnaires only.
We expect that after the intervention, participants in the intervention group will demonstrate improvements in the study outcomes compared with participants in the control group, and that some of these improvements will be maintained at the three-month follow-up. We further expect that the participants' level of caregiving involvement with their autistic sibling will be associated with the effectiveness of the intervention. 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.
- Conditions
- Autism Spectrum Disorder, Sibling Relations
- Being tested
- Psychoeducational program for ASD
- Keywords
- Psychoeducation, Siblings, Sibling Relationship, ASD, Autism Spectrum Disorder, Psychoeducational Program, Autism, Adult Siblings
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychoeducational program for ASDOther
6 psychoeducational sessions and one follow-up session for Autism Spectrum Disorder
| Study group | Role | What they receive |
|---|---|---|
| Psychoeducation Program Group | Experimental | Participants are going to participate in the online psychoeducational program for ASD.
Number of participants: 44.
They will will be asked to complete the online questionnaires three times (pre-intervention, post-intervention and at the three-month follow-up). Receives: Other: Psychoeducational program for ASD |
| Questionnaires Only Group | No intervention | Concurrently with the intervention group, the control group will be asked to complete the online questionnaires three times (pre-intervention, post-intervention and three-month follow-up). Number of participants: 44. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start28 Mar 2024
- Primary completion30 Oct 2024
- Study completion30 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Interventional groups and Control groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hellenic Mediterranean University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charalampos Depastas, Hellenic Mediterranean University
- Investigators
- CHARALAMPOS DEPASTAS, PhD stud., Principal investigator, Hellenic Mediterranean University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06361147
- Sponsor's protocol ID
- 3764/2-10-2019
- Status last verified
- Sep 2026
- First submitted
- 28 Mar 2024
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will keep the anonymity of participants and there is no plan to share their data to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Psychoeducation on Adult Siblings of People With Autism Spectrum Disorder.
- ClinicalTrials.gov ID
- NCT06361147
- Acronym / sponsor ID
- 3764/2-10-2019
- Conditions
- Autism Spectrum Disorder, Sibling Relations
- Keywords
- Psychoeducation, Siblings, Sibling Relationship, ASD, Autism Spectrum Disorder, Psychoeducational Program, Autism, Adult Siblings
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Hellenic Mediterranean UniversityUniversity, hospital or other
- Study start
- 28 Mar 2024 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 11 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to evaluate the effectiveness of a novel psychoeducational program for adult siblings of autistic individuals, aiming to improve autism-related knowledge, well-being, resilience and sibling relationship outcomes, 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.
We expect that after the intervention, participants in the intervention group will demonstrate improvements in the study outcomes compared with participants in the control group, and that some of these improvements will be maintained at the three-month follow-up. We further expect that the participants' level of caregiving involvement with their autistic sibling will be associated with the effectiveness of the intervention. No risk is identified.
Detailed description
Autism Spectrum Disorder (ASD) is a neurodevelopmental lifelong disorder of which prevalence has been significantly increased through the decades.
As a result, the rise in autism prevalence has been accompanied by a parallel increase in the number of individuals who have autistic siblings, a group estimated to number in the millions.
Although supportive interventions have demonstrated benefits for family members, existing research has primarily focused on autistic individuals and their parents. Consequently, evidence regarding interventions specifically designed for adult siblings remains limited.
The purpose of this study was to evaluate the effectiveness of a novel psychoeducational program for adult siblings of autistic individuals, aiming to improve autism-related knowledge, well-being, resilience and sibling relationship outcomes, while also highlighting the need for tailored supportive interventions for this population. The psychoeducational program aims to enhance understanding of autism, encourage emotional expression and a sense of belonging, improve family and sibling communication, and provide practical strategies for everyday challenges.
A parallel-group randomized controlled trial with assessments at baseline, post-intervention and three-month follow-up will be conducted among adult siblings of autistic individuals across Greece (voluntary participation). Participants will be randomly allocated (1:1) to the intervention or control group. The intervention comprise six free-of-charge online psychoeducational sessions and one follow-up session and will be delivered by two social workers certified in autism psychoeducation, whereas the control group will complete questionnaires only.
We expect that after the intervention, participants in the intervention group will demonstrate improvements in the study outcomes compared with participants in the control group, and that some of these improvements will be maintained at the three-month follow-up. We further expect that the participants' level of caregiving involvement with their autistic sibling will be associated with the effectiveness of the intervention. 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Interventional groups and Control groups
| Arm | Type | Receives |
|---|---|---|
| Psychoeducation Program Group | Experimental | Other: Psychoeducational program for ASDParticipants are going to participate in the online psychoeducational program for ASD. Number of participants: 44. They will will be asked to complete the online questionnaires three times (pre-intervention, post-intervention and at the three-month follow-up). |
| Questionnaires Only Group | No intervention | –Concurrently with the intervention group, the control group will be asked to complete the online questionnaires three times (pre-intervention, post-intervention and three-month follow-up). Number of participants: 44. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychoeducational program for ASD6 psychoeducational sessions and one follow-up session for Autism Spectrum Disorder | Other | Psychoeducation Program Group |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No. We will keep the anonymity of participants and there is no plan to share their data to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
CHARALAMPOS DEPASTAS, PhD stud. principal investigator
Hellenic Mediterranean University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychoeducational program for ASD in people with Autism Spectrum Disorder and Sibling Relations, run by Hellenic Mediterranean University at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychoeducation effectiveness on the knowledge of ASD (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.