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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05938751
Other study ID # FPCEE_TeamYoungAdults2020/2023
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 15, 2020
Est. completion date July 31, 2022

Study information

Verified date July 2023
Source University Ramon Llull
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date July 31, 2022
Est. primary completion date July 31, 2022
Accepts healthy volunteers No
Gender All
Age group 17 Years to 30 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Spain Ramon Llull University. Faculty of Psychology, Sciences of Education and Sports Blanquerna Barcelona
Spain University of Barcelona Barcelona

Sponsors (4)

Lead Sponsor Collaborator
University Ramon Llull Fundació Friends, Hospital de Mataró, University of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
Primary 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)
Primary 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 a = .948 to a = .962), as well as for the entire scale (a = .983), and there is also evidence of its validity. At baseline and after the completion of the intervention (20 weeks later)
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