Autism Spectrum DisorderCoMPPAANCT05813756
Validation Study of the Coping, Motivation and Post-diagnosis Psychoeducation Program for Adults With Autism
A study testing Post-diagnosctic psychoeducational intervention in people with Autism Spectrum Disorder, run by Centre Hospitalier Rouffach at 1 site in France.
Trial summary
The primary objective of the study is to evaluate the effectiveness of a post-diagnostic psychoeducational intervention in increasing the sense of self-efficacy of adults diagnosed with Autism Spectrum Disorder-Without associated Intellectual Disability Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Post-diagnosctic psychoeducational intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteFrance
- Study dates
- 20 Mar 2023to 30 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant aged 18 years and older at the time of inclusion in the study
- Participant with a diagnosis of Autism Spectrum Disorder - Without associated Intellectual Disability (intelligence quotient > 80) made by a specialized 2nd (1) or 3rd (2) line team according to the recommendations of the Haute Autorité de la Santé (HAS)
- Diagnosis of Autism Spectrum Disorder - Without associated Intellectual Disability obtained in adulthood (≥ 18 years) within 15 months prior to inclusion
- Participant able to understand the objectives and risks of the research and having signed a consent to participate in the study
- Participant affiliated with a social security plan or beneficiary of such a plan
- Psychiatric teams (psychiatric services including medical-psychological centers), care networks specialized in the diagnosis and evaluation of autism or private practitioners coordinated by a physician.
- Professionals working in autism resource centers or hospitals for additional specialized medical advice, particularly in clinical genetics and medical imaging.
Who cannot join
- Participant not sufficiently available to participate in the intervention
- Participant in full hospitalization
- Participant co-morbid with schizophrenia or other psychotic disorder according to DSM-5 criteria
- Impossibility of giving the participant informed information (participant in an emergency or life-threatening situation, difficulties in understanding the participant, insufficient command of the French language)
- Participant under court protection or deprived of liberty by judicial or administrative decision
- Participant under guardianship or curatoship
- Diagnosed with Autism Spectrum Disorder - Without associated Intellectual Disability in childhood or adolescence or in a period of more than 15 months prior to inclusion
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier de Rouffach
Rouffach, 68250
ERIC BIZET, PhD, 33 389249923, e.bizet@ch-rouffach.fr
About this study
Official title: Validation Study of the Coping, Motivation Ans Post-diagnosis Psychoeducation Program for Adults With Autism : a Randomized Controlled Trial
The primary objective of the study is to evaluate the effectiveness of a post-diagnostic psychoeducational intervention in increasing the sense of self-efficacy of adults diagnosed with Autism Spectrum Disorder-Without associated Intellectual Disability
Read the detailed description
Secondary objectives
The other objectives of this study are :
- To evaluate the effectiveness of the intervention on self-esteem ;
- To evaluate the effectiveness of the intervention on anxiety-depressive symptomatology ;
- To evaluate the effectiveness of the intervention on the acceptance of the diagnosis ;
- To evaluate the acceptance of the intervention.
Conduct of research The study will be offered to individuals diagnosed with autism spectrum disorder without associated intellectual developmental disabilities in adulthood.
After signing the consent form and verifying the eligibility criteria, participants will be randomized into the waiting list group or the intervention group.
In the intervention group : the participant will receive 10 one-hour individual sessions, bi-monthly, with an assessment at midterm (T1 : T0+~2.5 months), at the end of the intervention (T2 : T0 +~5 months) and 3 months after the intervention (T3 : T0 +~8 months).
In the waiting list group : the participant will receive the intervention at the exit of the research protocol (after T3).
At conclusion and at each visit, participants will complete questionnaires and scales defined in the protocol.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Post-diagnosctic psychoeducational intervention
- Keywords
- Psychoeducation, Autism, Self-determination, Adult
- 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.
Post-diagnosctic psychoeducational interventionOther
Participants are randomized to the intervention group. In this group, the participant receives 10 one-hour individual sessions of psychoeducational intervention, bi-monthly, with an evaluation at mid-term (T1:T0+~2.5 months), at the end of the intervention (T2 : T0+~5 months) and 3 months after the intervention (T3 : T0+~8 months). At the same time psychological questionnaires and scales will be completed
| Study group | Role | What they receive |
|---|---|---|
| Experimental_Adults with Autism Spectrum Disorder | Experimental | post diagnostic psychoeducational intervention and filling of scale and questionnaire Receives: Other: Post-diagnosctic psychoeducational intervention |
| Adults with Autism Spectrum Disorder | No intervention | Filling of scale and questionnaire. |
What is being measured
The primary outcome is the main question the study is designed to answer.
General Self-Efficacy Scale
It is a unidimensional scale that assesses beliefs in one's ability to achieve goals and to cope with and/or adapt to various situations that may arise in daily life. This measure consists of 10 items rated on a 4-point Likert scale (1= "not at all true" ; 4 = "completely true"). Overall scores range from 10 to 40, with higher scores indicating a greater sense of self-efficacy.
Measured: Change from inclusion result at 8 months
Secondary outcomes (5)
Self-Esteem Scale
This instrument, which assesses individuals' overall perception of their own worth, includes 10 items rated on a 4-point Likerts scale (1 = "strongly disagree", 4 = "strongly agree").
Measured: Through study completion , an average of 8 months
Depression Anxiety Stress Scale
This instrument, which assesses psychological distress through indicators of stress and anxiety-depressive symptomatology (in the previous week), has been validated (in its English version) in an autistic population Without associated Intellectual Disability.
This measure consists of 20 items rated on a 4-point Likert scale (1= "not at all" ; 4 = "all the time"). Overall scores range from 20 to 80, with higher scores indicating severe depression and anxiety
Measured: Through study completion , an average of 8 months
Acceptance and Action Questionnaire_Version 2
Questionnaire that specifically targets acceptance of Autism Spectrum Disorder diagnosis This measure consists of 7 items rated on a 7-point Likert scale (1= "never true" ; 7 = "always true"). Overall scores range from 7 to 49, with higher scores indicating a non-acceptance of the diagnosis
Measured: Through study completion , an average of 8 months
Social validity measures (in-house questionnaires)
Acceptance of the intervention will be assessed by social validity measures that will take the form of a questionnaire developed in-house and including items on: expectations (visit 0) and satisfaction halfway through the intervention (visit 1) and (visit 2), use of strategies (visit 3) and knowledge about autism spectrum disorders.
This measure consists of 10 items rated on a 4-point Likert scale (1= "completely disagree" ; 4 = "totally agree"). Overall scores range from 10 to 40, with higher scores indicating a high social validity.
Measured: Through study completion , an average of 8 months
qualitative data (semi-structured interviews)
Acceptance of the intervention will be assessed by qualitative data collected through semi-structured interviews (visit 2 and visit 3: only for the "intervention" group with already defined themes).
There is no score, then no minimum and maximum values (exchange in the form of organized notes).
Measured: Through study completion , an average of 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2023
- Study start20 Mar 2023
- Primary completion30 Oct 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Rouffach
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ERIC BIZET, PhD, Principal investigator, Autism Resource Center Colmar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05813756
- Sponsor's protocol ID
- CHR 10
- Other IDs
- 2022-A02489-34
- Acronym
- CoMPPAA
- Status last verified
- Mar 2023
- First submitted
- 20 Mar 2023
- Last updated
- 14 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation Study of the Coping, Motivation Ans Post-diagnosis Psychoeducation Program for Adults With Autism : a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05813756
- Acronym / sponsor ID
- CoMPPAA / CHR 10
- Conditions
- Autism Spectrum Disorder
- Keywords
- Psychoeducation, Autism, Self-determination, Adult
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Centre Hospitalier RouffachUniversity, hospital or other
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- 30 Oct 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 14 Apr 2023 (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 primary objective of the study is to evaluate the effectiveness of a post-diagnostic psychoeducational intervention in increasing the sense of self-efficacy of adults diagnosed with Autism Spectrum Disorder-Without associated Intellectual Disability
Detailed description
Secondary objectives
The other objectives of this study are :
- To evaluate the effectiveness of the intervention on self-esteem ;
- To evaluate the effectiveness of the intervention on anxiety-depressive symptomatology ;
- To evaluate the effectiveness of the intervention on the acceptance of the diagnosis ;
- To evaluate the acceptance of the intervention.
Conduct of research The study will be offered to individuals diagnosed with autism spectrum disorder without associated intellectual developmental disabilities in adulthood.
After signing the consent form and verifying the eligibility criteria, participants will be randomized into the waiting list group or the intervention group.
In the intervention group : the participant will receive 10 one-hour individual sessions, bi-monthly, with an assessment at midterm (T1 : T0+~2.5 months), at the end of the intervention (T2 : T0 +~5 months) and 3 months after the intervention (T3 : T0 +~8 months).
In the waiting list group : the participant will receive the intervention at the exit of the research protocol (after T3).
At conclusion and at each visit, participants will complete questionnaires and scales defined in the protocol.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental_Adults with Autism Spectrum Disorder | Experimental | Other: Post-diagnosctic psychoeducational interventionpost diagnostic psychoeducational intervention and filling of scale and questionnaire |
| Adults with Autism Spectrum Disorder | No intervention | –Filling of scale and questionnaire. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participant aged 18 years and older at the time of inclusion in the study
- Participant with a diagnosis of Autism Spectrum Disorder - Without associated Intellectual Disability (intelligence quotient > 80) made by a specialized 2nd (1) or 3rd (2) line team according to the recommendations of the Haute Autorité de la Santé (HAS)
- Diagnosis of Autism Spectrum Disorder - Without associated Intellectual Disability obtained in adulthood (≥ 18 years) within 15 months prior to inclusion
- Participant able to understand the objectives and risks of the research and having signed a consent to participate in the study
- Participant affiliated with a social security plan or beneficiary of such a plan
Key exclusion criteria (7 listed)
- Participant not sufficiently available to participate in the intervention
- Participant in full hospitalization
- Participant co-morbid with schizophrenia or other psychotic disorder according to DSM-5 criteria
- Impossibility of giving the participant informed information (participant in an emergency or life-threatening situation, difficulties in understanding the participant, insufficient command of the French language)
- Participant under court protection or deprived of liberty by judicial or administrative decision
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 |
|---|---|---|
| Post-diagnosctic psychoeducational interventionParticipants are randomized to the intervention group. In this group, the participant receives 10 one-hour individual sessions of psychoeducational intervention, bi-monthly, with an evaluation at mid-term (T1:T0+~2.5 months), at the end of the intervention (T2 : T0+~5 months) and 3 months after the intervention (T3 : T0+~8 months). At the same time psychological questionnaires and scales will be completed | Other | Experimental_Adults with Autism Spectrum Disorder |
Primary outcome
General Self-Efficacy Scale
Time frame: Change from inclusion result at 8 months
It is a unidimensional scale that assesses beliefs in one's ability to achieve goals and to cope with and/or adapt to various situations that may arise in daily life. This measure consists of 10 items rated on a 4-point Likert scale (1= "not at all true" ; 4 = "completely true"). Overall scores range from 10 to 40, with higher scores indicating a greater sense of self-efficacy.
5 secondary outcomes
Self-Esteem Scale
Time frame: Through study completion , an average of 8 months
Depression Anxiety Stress Scale
Time frame: Through study completion , an average of 8 months
Acceptance and Action Questionnaire_Version 2
Time frame: Through study completion , an average of 8 months
Social validity measures (in-house questionnaires)
Time frame: Through study completion , an average of 8 months
qualitative data (semi-structured interviews)
Time frame: Through study completion , an average of 8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
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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.
ERIC BIZET, PhD principal investigator
Autism Resource Center Colmar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Post-diagnosctic psychoeducational intervention in people with Autism Spectrum Disorder, run by Centre Hospitalier Rouffach at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 14 Apr 2023. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ERIC BIZET, PhD (33 389249923, e.bizet@ch-rouffach.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General Self-Efficacy Scale (time frame: Change from inclusion result at 8 months). 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 14 Apr 2023.