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

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

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.

Study Overview

• Status: Completed
• Conditions: Autism
• Intervention / Treatment: Behavioral: TEAm_YOUNG ADULTS program

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08022
    • Ramon Llull University. Faculty of Psychology, Sciences of Education and Sports Blanquerna
  • Barcelona, Spain, 08035
    • University of Barcelona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At baseline and after the completion of the intervention (20 weeks later)
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.	After the completion of the intervention (20 weeks later)
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.	At baseline and after the completion of the intervention (20 weeks later)

Collaborators and Investigators

• Sponsor: University Ramon Llull
• Collaborators: University of Barcelona; Hospital de Mataró; Fundació Friends
• Investigators: Principal Investigator: Clara Andrés Gárriz, M.D., University Ramon Llull

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2020
• Primary Completion (Actual): July 31, 2022
• Study Completion (Actual): July 31, 2022

Study Registration Dates

• First Submitted: June 20, 2023
• First Submitted That Met QC Criteria: July 1, 2023
• First Posted (Actual): July 10, 2023

Study Record Updates

• Last Update Posted (Actual): July 10, 2023
• Last Update Submitted That Met QC Criteria: July 1, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Intervention; Young adults; Self-determination; Mixed-methods
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder; Autistic Disorder
• Other Study ID Numbers: FPCEE_TeamYoungAdults2020/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No