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

April 12, 2023 updated by: Centre Hospitalier Rouffach

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Rouffach, France, 68250
        • Recruiting
        • CENTRE HOSPITALIER DE ROUFFACH
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental_Adults with Autism Spectrum Disorder
post diagnostic psychoeducational intervention and filling of scale and questionnaire
Other: Post-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
No Intervention: Adults with Autism Spectrum Disorder
Filling of scale and questionnaire.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from inclusion result at 8 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-Esteem Scale
Time Frame: Through study completion , an average of 8 months
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").
Through study completion , an average of 8 months
Depression Anxiety Stress Scale
Time Frame: Through study completion , an average of 8 months

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
Through study completion , an average of 8 months
Acceptance and Action Questionnaire_Version 2
Time Frame: Through study completion , an average of 8 months
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
Through study completion , an average of 8 months
Social validity measures (in-house questionnaires)
Time Frame: Through study completion , an average of 8 months

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.
Through study completion , an average of 8 months
qualitative data (semi-structured interviews)
Time Frame: Through study completion , an average of 8 months

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).
Through study completion , an average of 8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Rouffach

Investigators

  • Principal Investigator: ERIC BIZET, PhD, Autism Resource Center Colmar

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2023

Primary Completion (Anticipated)

October 30, 2024

Study Completion (Anticipated)

December 30, 2024

Study Registration Dates

First Submitted

March 20, 2023

First Submitted That Met QC Criteria

April 12, 2023

First Posted (Actual)

April 14, 2023

Study Record Updates

Last Update Posted (Actual)

April 14, 2023

Last Update Submitted That Met QC Criteria

April 12, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHR 10
  • 2022-A02489-34 (Other Identifier: COMITE DE PROTECTION DES PERSONNES SUD-EST VI)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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