Developing a Culturally Adapted Intervention for Latino Youth Transitioning to Adulthood

NCT ID: NCT06107972

Last Updated: 2025-08-27

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2025-12-31

Brief Summary

The purpose of this study is to evaluate the acceptability, feasibility (e.g., satisfaction, completion rate, barriers to recruitment, treatment fidelity) of the culturally refined Launching! to Adulthood (¡Iniciando! la Adultez) program, to test for a preliminary signal of effect between baseline and post-treatment for the Launching! to Adulthood (¡Iniciando! la Adultez) program and to identify preliminary neural mechanisms of action, including biomarkers of brain structure and connectivity, in terms of treatment response for 15 Latino young adults participating in the ¡Iniciando! therapy program.

Detailed Description

The Launching! to Adulthood (¡Iniciando! la Adultez) program uses a culturally sensitive therapy program that was translated into Spanish to help Latino young adults with Autism Spectrum Disorder (ASD) who are transitioning to adulthood (18-25 years old) and their parents. The program aims to make the transition to adulthood easier for young adults and their families, and it includes specific cultural values of Latino young adults and their family members. The ¡Iniciando! la adultez program helps autistic young adults manage mental health needs like depression and anxiety and also addresses several areas impacting transition, including mental health barriers, executive functioning, and motivation. The ¡Iniciando! program also helps parents manage their own needs and addresses several areas, including psychoeducation and mental health.

Conditions

Autism Spectrum Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Launching! to Adulthood (¡Iniciando! la Adultez) program

Group Type: EXPERIMENTAL

Launching! to Adulthood (¡Iniciando! la Adultez) program

Intervention Type: BEHAVIORAL

The program includes cognitive behavioral and acceptance and commitment therapy, with a focus on developing goals during the transition to adulthood through a values framework. After a combined (parents and young adults) 90-minute introductory group meeting in-person, parents and the transition-aged young adults with ASD attend 9 separate, 90-minute weekly group telehealth meetings. Additionally, young adults have weekly personal coaching meetings for 30-minutes to discuss progress toward goals and barriers encountered. Leaders teach transition-aged young adult's skills through various social activities, as well as other skills (e.g., emotion regulation, cognitive diffusion) to help overcome barriers towards their goals. The treatment targets three core factors (i.e., mental health conditions, social skills, and coping with and adapting to stress). Leaders teach parents new parenting skills, knowledge of ASD, and readiness to support their young adult's transition to independent life.

Interventions

Launching! to Adulthood (¡Iniciando! la Adultez) program

The program includes cognitive behavioral and acceptance and commitment therapy, with a focus on developing goals during the transition to adulthood through a values framework. After a combined (parents and young adults) 90-minute introductory group meeting in-person, parents and the transition-aged young adults with ASD attend 9 separate, 90-minute weekly group telehealth meetings. Additionally, young adults have weekly personal coaching meetings for 30-minutes to discuss progress toward goals and barriers encountered. Leaders teach transition-aged young adult's skills through various social activities, as well as other skills (e.g., emotion regulation, cognitive diffusion) to help overcome barriers towards their goals. The treatment targets three core factors (i.e., mental health conditions, social skills, and coping with and adapting to stress). Leaders teach parents new parenting skills, knowledge of ASD, and readiness to support their young adult's transition to independent life.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• confirmed case of ASD
• a score of >14 on the Social Communication Questionnaire-Lifetime (SCQ-L110) completed with the mother or father
• meet DSM-5 criteria for ASD based on a Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 ASD symptom checklist
• previous diagnosis of ASD from a licensed mental health or medical professional
• speak English
• have a parent willing to participate
• score >85 on verbal intelligence quotient (IQ) on the Kaufman Brief Intelligence Test (KBIT-2)

Exclusion Criteria

• history of a psychotic disorder or current psychotic symptoms
• suicidal ideation with intent or plan
• current alcohol or other substance use disorder rated severe
• concurrent enrollment in another clinical trial for autism spectrum disorder
• expression of unwillingness to complete study procedures
• For fMRI, unable to undergo fMRI scanning due to metallic devices or objects (cardiac pacemaker or neurostimulator, some artificial joints, metal pins, surgical clips, or other implanted metal parts) or claustrophobic to the scanner.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UTHealth Houston Seed Grant and Autism Speaks Fellowship

UNKNOWN

Sponsor Role: collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Antonio Pagan

Postdoctoral Research Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Antonio Pagan, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Countries

United States

Other Identifiers

HSC-MS-23-0188

Identifier Type: -

Identifier Source: org_study_id