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

Primary Purpose

Autism

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
TEAm_YOUNG ADULTS program
Sponsored by
University Ramon Llull
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism focused on measuring Self-determination, Intervention, Young adults, Mixed-methods

Eligibility Criteria

17 Years - 30 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Ramon Llull University. Faculty of Psychology, Sciences of Education and Sports Blanquerna
  • University of Barcelona

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Waiting list group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Change from baseline Self-determination after 20 sessions (Quantitative measure: self-report)
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)
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)
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.

Secondary Outcome Measures

Full Information

First Posted
June 20, 2023
Last Updated
July 1, 2023
Sponsor
University Ramon Llull
Collaborators
Hospital de Mataró, Fundació Friends, University of Barcelona
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1. Study Identification

Unique Protocol Identification Number
NCT05938751
Brief Title
An Intervention to Promote Self-determination in Young Adults With Autism: the TEAm_YOUNG ADULTS Program
Acronym
TEAm_YA
Official Title
A Multicentric Mixed-methods Study About the Promotion of Self-determination in Young Adults With Autism: the TEAm_YOUNG ADULTS Program
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
October 15, 2020 (Actual)
Primary Completion Date
July 31, 2022 (Actual)
Study Completion Date
July 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Ramon Llull
Collaborators
Hospital de Mataró, Fundació Friends, University of Barcelona

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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism
Keywords
Self-determination, Intervention, Young adults, Mixed-methods

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Masking
None (Open Label)
Masking Description
Masking was not possible due to the resources of this study.
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Participants in this group received the TEAm_YOUNG ADULTS program, an intervention to promote and develop self-determination-related skills.
Arm Title
Waiting list group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
TEAm_YOUNG ADULTS program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline Self-determination after 20 sessions (Quantitative measure: self-report)
Description
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.
Time Frame
At baseline and after the completion of the intervention (20 weeks later)
Title
Self-determination (Qualitative measure)
Description
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.
Time Frame
After the completion of the intervention (20 weeks later)
Title
Change from baseline Self-determination after 20 sessions (Quantitative measure: proxy-report)
Description
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.
Time Frame
At baseline and after the completion of the intervention (20 weeks later)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clara Andrés Gárriz, M.D.
Organizational Affiliation
University Ramon Llull
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ramon Llull University. Faculty of Psychology, Sciences of Education and Sports Blanquerna
City
Barcelona
ZIP/Postal Code
08022
Country
Spain
Facility Name
University of Barcelona
City
Barcelona
ZIP/Postal Code
08035
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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