Clinical trial NCT05938751: An Intervention to Promote Self-determination in Young Adults With Autism: the TEAm_YOUNG ADULTS Program
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
Overall status: COMPLETED
Phase: NA
Conditions: Autism
Keywords: Self-determination
Intervention
Young adults
Mixed-methods
Lead sponsor: University Ramon Llull
Sponsor class: OTHER
Collaborators: name: Hospital de Mataró
name: Fundació Friends
name: University of Barcelona
First posted: 2023-07-10
Enrollment: 40
Sex: ALL
Minimum age (years): 17
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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)
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from baseline Self-determination after 20 sessions (Quantitative measure: self-report)
timeFrame: At baseline and after the completion of the intervention (20 weeks later)
measure: Self-determination (Qualitative measure)
timeFrame: After the completion of the intervention (20 weeks later)
measure: Change from baseline Self-determination after 20 sessions (Quantitative measure: proxy-report)
timeFrame: At baseline and after the completion of the intervention (20 weeks later)
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Ramon Llull University. Faculty of Psychology, Sciences of Education and Sports Blanquerna
city: Barcelona
country: Spain
facility: University of Barcelona
Study officials:
affiliation: University Ramon Llull
name: Clara Andrés Gárriz, M.D.
role: PRINCIPAL_INVESTIGATOR
References: