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

July 1, 2023 updated by: Clara Andrés Gárriz, University Ramon Llull

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
At baseline and after the completion of the intervention (20 weeks later)
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.
After the completion of the intervention (20 weeks later)
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.
At baseline and after the completion of the intervention (20 weeks later)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Ramon Llull

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Barcelona
Hospital de Mataró
Fundació Friends

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Clara Andrés Gárriz, M.D., University Ramon Llull

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 15, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 20, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 10, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 10, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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