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Validation Study of the Coping, Motivation and Post-diagnosis Psychoeducation Program for Adults With Autism

Validation Study of the Coping, Motivation Ans Post-diagnosis Psychoeducation Program for Adults With Autism : a Randomized Controlled Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05813756
Acronym
CoMPPAA
Enrollment
66
Registered
2023-04-14
Start date
2023-03-20
Completion date
2024-12-30
Last updated
2023-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder

Keywords

Psychoeducation, Autism, Self-determination, Adult

Brief 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

Detailed description

Secondary objectives The other objectives of this study are : 1. To evaluate the effectiveness of the intervention on self-esteem ; 2. To evaluate the effectiveness of the intervention on anxiety-depressive symptomatology ; 3. To evaluate the effectiveness of the intervention on the acceptance of the diagnosis ; 4. 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.

Interventions

OTHERPost-diagnosctic psychoeducational intervention

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

Sponsors

Centre Hospitalier Rouffach
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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 1. 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. 2. Professionals working in autism resource centers or hospitals for additional specialized medical advice, particularly in clinical genetics and medical imaging.

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
General Self-Efficacy ScaleChange from inclusion result at 8 monthsIt 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.

Secondary

MeasureTime frameDescription
Self-Esteem ScaleThrough study completion , an average of 8 monthsThis 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).
Depression Anxiety Stress ScaleThrough study completion , an average of 8 monthsThis 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
Acceptance and Action Questionnaire_Version 2Through study completion , an average of 8 monthsQuestionnaire 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
Social validity measures (in-house questionnaires)Through study completion , an average of 8 monthsAcceptance 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.
qualitative data (semi-structured interviews)Through study completion , an average of 8 monthsAcceptance 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).

Countries

France

Contacts

Primary ContactERIC BIZET, PhD
e.bizet@ch-rouffach.fr33 389249923

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026