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Clinical Trials/NCT05938751
NCT05938751
Completed
Not Applicable

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

University Ramon Llull2 sites in 1 country40 target enrollmentOctober 15, 2020
ConditionsAutism

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Autism
Sponsor
University Ramon Llull
Enrollment
40
Locations
2
Primary Endpoint
Self-determination (Qualitative measure)
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 15, 2020
End Date
July 31, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Ramon Llull
Responsible Party
Principal Investigator
Principal Investigator

Clara Andrés Gárriz

Principal Investigator

University Ramon Llull

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

Outcomes

Primary Outcomes

Self-determination (Qualitative measure)

Time Frame: 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)

Time Frame: 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.

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

Time Frame: 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.

Study Sites (2)

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