NCT05813756

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 20, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

March 20, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

April 14, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

April 14, 2023

Status Verified

March 1, 2023

Enrollment Period

1.6 years

First QC Date

March 20, 2023

Last Update Submit

April 12, 2023

Conditions

Autism Spectrum Disorder

Keywords

PsychoeducationAutismSelf-determinationAdult

Outcome Measures

Primary Outcomes (1)

  • 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.

    Change from inclusion result at 8 months

Secondary Outcomes (5)

  • Self-Esteem Scale

    Through study completion , an average of 8 months

  • Depression Anxiety Stress Scale

    Through study completion , an average of 8 months

  • Acceptance and Action Questionnaire_Version 2

    Through study completion , an average of 8 months

  • Social validity measures (in-house questionnaires)

    Through study completion , an average of 8 months

  • qualitative data (semi-structured interviews)

    Through study completion , an average of 8 months

Study Arms (2)

Experimental_Adults with Autism Spectrum Disorder

EXPERIMENTAL

post diagnostic psychoeducational intervention and filling of scale and questionnaire

Other: Post-diagnosctic psychoeducational intervention

Adults with Autism Spectrum Disorder

NO INTERVENTION

Filling of scale and questionnaire.

Interventions

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

Experimental_Adults with Autism Spectrum Disorder

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier de Rouffach

Rouffach, 68250, France

RECRUITING

MeSH Terms

Conditions

Autism Spectrum DisorderAutistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • ERIC BIZET, PhD

    Autism Resource Center Colmar

    PRINCIPAL INVESTIGATOR

Central Study Contacts

ERIC BIZET, PhD

CONTACT

33 389249923e.bizet@ch-rouffach.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2023

First Posted

April 14, 2023

Study Start

March 20, 2023

Primary Completion

October 30, 2024

Study Completion

December 30, 2024

Last Updated

April 14, 2023

Record last verified: 2023-03

Locations

FR(1)