Validation Study of the Coping, Motivation and Post-diagnosis Psychoeducation Program for Adults With Autism - Clinical Trial for Autism Spectrum Disorder | NCT05813756

Back to results

Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Post-diagnosctic psychoeducational intervention

About this trial

This is an interventional other trial for Autism Spectrum Disorder focused on measuring Psychoeducation, Autism, Self-determination, Adult

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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. 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

Sites / Locations

Centre Hospitalier de RouffachRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental_Adults with Autism Spectrum Disorder

Adults with Autism Spectrum Disorder

Arm Description

post diagnostic psychoeducational intervention and filling of scale and questionnaire

Filling of scale and questionnaire.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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").

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

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

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.

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).

Full Information

NCT ID

NCT05813756

First Posted

March 20, 2023

Last Updated

April 12, 2023

Sponsor

Centre Hospitalier Rouffach

1. Study Identification

Unique Protocol Identification Number

NCT05813756

Brief Title

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

Acronym

CoMPPAA

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 20, 2023 (Actual)

Primary Completion Date

October 30, 2024 (Anticipated)

Study Completion Date

December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Hospitalier Rouffach

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

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 : 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Autism Spectrum Disorder

Keywords

Psychoeducation, Autism, Self-determination, Adult

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental_Adults with Autism Spectrum Disorder

Arm Type

Experimental

Arm Description

post diagnostic psychoeducational intervention and filling of scale and questionnaire

Arm Title

Adults with Autism Spectrum Disorder

Arm Type

No Intervention

Arm Description

Filling of scale and questionnaire.

Intervention Type

Other

Intervention Name(s)

Post-diagnosctic psychoeducational intervention

Intervention Description

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

Primary Outcome Measure Information:

Title

General Self-Efficacy Scale

Description

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.

Time Frame

Change from inclusion result at 8 months

Secondary Outcome Measure Information:

Title

Self-Esteem Scale

Description

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").

Time Frame