Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2025-12-25 @ 9:09 PM
Study NCT ID:
NCT05813756
Status:
UNKNOWN
Last Update Posted:
2023-04-14
First Post:
2023-03-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Validation Study of the Coping, Motivation and Post-diagnosis Psychoeducation Program for Adults With Autism
Sponsor:
Centre Hospitalier Rouffach
Organization:
Study Overview
Official Title:
Validation Study of the Coping, Motivation Ans Post-diagnosis Psychoeducation Program for Adults With Autism : a Randomized Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2023-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CoMPPAA
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2022-A02489-34 | OTHER | COMITE DE PROTECTION DES PERSONNES SUD-EST VI | View |