NCT05938751

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2020

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Study Start

First participant enrolled

October 15, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 20, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 10, 2023

Completed
Last Updated

July 10, 2023

Status Verified

July 1, 2023

Enrollment Period

1.8 years

First QC Date

June 20, 2023

Last Update Submit

July 1, 2023

Conditions

Keywords

Self-determinationInterventionYoung adultsMixed-methods

Outcome Measures

Primary Outcomes (3)

  • 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)

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Waiting list group

NO INTERVENTION

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.

Interventions

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.

Intervention group

Eligibility Criteria

Age17 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

Barcelona, 08022, Spain

Location

University of Barcelona

Barcelona, 08035, Spain

Location

Related Publications (1)

  • Andres-Garriz C, Farriols Hernando N, Gomez Hinojosa AM, Pretel-Luque T, Fabregues S, Mumbardo-Adam C. Promoting Self-Determination in Young Adults with Autism: A Multicenter, Mixed Methods Study. J Autism Dev Disord. 2025 Feb 15. doi: 10.1007/s10803-025-06739-6. Online ahead of print.

MeSH Terms

Conditions

Autistic Disorder

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Clara Andrés Gárriz, M.D.

    University Ramon Llull

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Masking was not possible due to the resources of this study.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 20, 2023

First Posted

July 10, 2023

Study Start

October 15, 2020

Primary Completion

July 31, 2022

Study Completion

July 31, 2022

Last Updated

July 10, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations