Clinical trial NCT05813756: Validation Study of the Coping, Motivation and Post-diagnosis Psychoeducation Program for Adults With Autism
Official title: Validation Study of the Coping, Motivation Ans Post-diagnosis Psychoeducation Program for Adults With Autism : a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Psychoeducation
Autism
Self-determination
Adult
Lead sponsor: Centre Hospitalier Rouffach
Sponsor class: OTHER
First posted: 2023-04-14
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: General Self-Efficacy Scale
timeFrame: Change from inclusion result at 8 months
Secondary outcomes:
measure: Self-Esteem Scale
timeFrame: Through study completion , an average of 8 months
measure: Depression Anxiety Stress Scale
timeFrame: Through study completion , an average of 8 months
measure: Acceptance and Action Questionnaire_Version 2
timeFrame: Through study completion , an average of 8 months
measure: Social validity measures (in-house questionnaires)
timeFrame: Through study completion , an average of 8 months
measure: qualitative data (semi-structured interviews)
timeFrame: Through study completion , an average of 8 months
Other outcomes:
Locations:
city: Rouffach
country: France
facility: Centre Hospitalier de Rouffach
Study officials:
affiliation: Autism Resource Center Colmar
name: ERIC BIZET, PhD
role: PRINCIPAL_INVESTIGATOR
References: