TEAm_YA: An Intervention to Promote Self-determination in Young Adults With Autism: the TEAm_YOUNG ADULTS Program

Sponsor

University Ramon Llull (Other)

Overall Status

Completed

CT.gov ID

NCT05938751

Collaborator

Hospital de Mataró (Other), Fundació Friends (Other), University of Barcelona (Other)

Enrollment

Locations

Arms

21.5

Actual Duration (Months)

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this clinical trial is to test the benefits of a program to develop self-determination in young adults with autism. Being self-determined means acting or causing things to happen in your life. It involves deciding, acting and believing in one-self.

The main question this clinical trial aims to answer is: Is the program developed useful to improve self-determination of young adults with autism?

Participants will receive a group intervention to support the development of their self-determination-related skills during 20 sessions (1 session/week).

Researchers will compare the self-determination outcomes between the group that receives the intervention and another group that is in a waiting list (and will receive the intervention later) to see if the changes are due to the intervention.

Condition or Disease	Intervention/Treatment	Phase
Autism	Behavioral: TEAm_YOUNG ADULTS program	N/A

Detailed Description

This clinical trial employed a convergent mixed methods design. Quantitative and qualitative data were collected from the same participants and analyzed separately within a similar timeframe. The quantitative strand used self-reported and proxy-reported questionnaires to evaluate the impact of the TEAm_YOUNG ADULTS program on the self-determination of young adults with autism. The quantitative data was collected at baseline and at the completion of the program, after 5 months (20 sessions). In the qualitative strand, focus groups were used to explore changes in self-determination perceived by the participants that received the program and their acceptance of the intervention. The focus groups were conducted when finishing the group and after the self-reported questionnaires are answered. Proxy-reports were answered after the realization of the focus groups.

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Participants were assigned to the experimental group (which received the intervention) or to the control group (in a waiting list to receive the intervention after the conclusion of the study)Participants were assigned to the experimental group (which received the intervention) or to the control group (in a waiting list to receive the intervention after the conclusion of the study)

Masking:

None (Open Label)

Masking Description:

Masking was not possible due to the resources of this study.

Primary Purpose:

Treatment

Official Title:

A Multicentric Mixed-methods Study About the Promotion of Self-determination in Young Adults With Autism: the TEAm_YOUNG ADULTS Program

Actual Study Start Date :

Oct 15, 2020

Actual Primary Completion Date :

Jul 31, 2022

Actual Study Completion Date :

Jul 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention group Participants in this group received the TEAm_YOUNG ADULTS program, an intervention to promote and develop self-determination-related skills.	Behavioral: TEAm_YOUNG ADULTS program The TEAm_YOUNG ADULTS program is an intervention to develop self-determination in young adults with autism. It consists of 20 1.5h weekly sessions. The intervention is conducted by two facilitators with expertise in autism and self-determination promotion. Groups are formed by 4 to 6 participants. The program can be applied online or in person. The first five sessions address specific characteristics and support needs of people with autism. The next ten sessions are focused on the development of self-determination. The last five sessions are focused on working with others and the closure of the group. The individual goals of every participant are considered in the beginning of the group and a weekly follow-up of goals is conducted.
No Intervention: Waiting list group Participants in this group were on the waiting list. That means they had to wait until the intervention group received the intervention and post-test evaluation to receive the intervention. They could keep their intervention as usual during the whole study.

Arm

Intervention/Treatment

Experimental: Intervention group

Participants in this group received the TEAm_YOUNG ADULTS program, an intervention to promote and develop self-determination-related skills.

Behavioral: TEAm_YOUNG ADULTS program

The TEAm_YOUNG ADULTS program is an intervention to develop self-determination in young adults with autism. It consists of 20 1.5h weekly sessions. The intervention is conducted by two facilitators with expertise in autism and self-determination promotion. Groups are formed by 4 to 6 participants. The program can be applied online or in person. The first five sessions address specific characteristics and support needs of people with autism. The next ten sessions are focused on the development of self-determination. The last five sessions are focused on working with others and the closure of the group. The individual goals of every participant are considered in the beginning of the group and a weekly follow-up of goals is conducted.

No Intervention: Waiting list group

Participants in this group were on the waiting list. That means they had to wait until the intervention group received the intervention and post-test evaluation to receive the intervention. They could keep their intervention as usual during the whole study.

Outcome Measures

Primary Outcome Measures

Change from baseline Self-determination after 20 sessions (Quantitative measure: self-report) [At baseline and after the completion of the intervention (20 weeks later)]
Self-Determination Inventory: Student Report (SDI:SR). The Spanish adaptation was used. It is a self-report measure that evaluates the three dimensions of self-determination based on Causal Agency Theory (volitional action, agentic action and action-control beliefs) as well as the total self-determination scores.
Self-determination (Qualitative measure) [After the completion of the intervention (20 weeks later)]
Focus groups to evaluate the changes after the completion of the intervention. Questions related to the three dimensions of self-determination will be asked (volitional action, agentic action and action-control beliefs) in accordance with the quantitative measures to allow a joint display of the results following a mixed methodology (quantitative and qualitative). The focus groups will only be conducted for the intervention groups.
Change from baseline Self-determination after 20 sessions (Quantitative measure: proxy-report) [At baseline and after the completion of the intervention (20 weeks later)]
AUTODDIS Scale. It is a proxy-report measure that evaluates the three dimensions of self-determination based on Causal Agency Theory (volitional action, agentic action and action-control beliefs) as well as the total self-determination scores. The internal consistency of these sections was excellent (between α = .948 to α = .962), as well as for the entire scale (α = .983), and there is also evidence of its validity.

Eligibility Criteria

Criteria

Ages Eligible for Study:

17 Years to 30 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

To have a diagnosis of autism spectrum disorder in accordance with the criteria of the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5), or of Asperger's syndrome, according to he DSM-IV
To be between 17 and 30 years old.
To have a verbal comprehension index higher than 70 in the Wechsler Adult Intelligence Scale-IV (WAIS-IV), to ensure a good comprehension of the program

Exclusion Criteria:

Not having spoken language
Having a condition that could significantly interfere in the group functioning, such as an acute psychotic disorder or challenging behavior

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ramon Llull University. Faculty of Psychology, Sciences of Education and Sports Blanquerna	Barcelona		Spain	08022
2	University of Barcelona	Barcelona		Spain	08035

Sponsors and Collaborators

University Ramon Llull
Hospital de Mataró
Fundació Friends
University of Barcelona

Investigators

Principal Investigator: Clara Andrés Gárriz, M.D., University Ramon Llull

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Clara Andrés Gárriz, Principal Investigator, University Ramon Llull

ClinicalTrials.gov Identifier:

NCT05938751

Other Study ID Numbers:

FPCEE_TeamYoungAdults2020/2023

First Posted:

Jul 10, 2023

Last Update Posted:

Jul 10, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Clara Andrés Gárriz, Principal Investigator, University Ramon Llull

Additional relevant MeSH terms:

Autistic Disorder

Study Results

No Results Posted as of Jul 10, 2023