Developing a Culturally Adapted Intervention for Latino Youth Transitioning to Adulthood

NCT06107972 | Active Not Recruiting

• 1 other identifier: HSC-MS-23-0188
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (4)

• Change in adaptive behavior as assessed by the Adaptive Behaviour Assessment System, Third Edition

  This is a 239 item questionnaire and each is scored from 0(is not able to do this behavior) to 3 \[(always able to do this behavior)(or almost always)\] a higher number indicating better outcome

  baseline, mid-treatment (5 weeks after baseline) , post-treatment (12 weeks after baseline), 3 month follow up, 6 month follow up

• Change in Quality of life as assessed by the Autism Spectrum Quality of Life (ASQoL) questionnaire

  This is a 9 item questionnaire. Questions 1-5 and 9 are each scored from 1(not at all) to 5(totally) a higher number indicating better outcome and questions 6-8 are reverse scored from 5(never) to 1(always) a higher score indicating worse outcome

  baseline, mid-treatment (5 weeks after baseline) , post-treatment (12 weeks after baseline), 3 month follow up, 6 month follow up

• Change in Anxiety as assessed by the Generalized Anxiety Disorder-7 (GAD7)

  This is a 7 item questionnaire and each is scored from 0(not at all) to 4(nearly every day) for a maximum score of 21 , higher score indicating more anxiety

  baseline, mid-treatment(5 weeks after baseline) , post-treatment (12 weeks after baseline), 3 month follow up, 6 month follow up

• Change in depression as assessed by the Patient Health Questionnaire (PHQ-9)

  This is a 9 item questionnaire and each is scored from 0(not at all) to 3(nearly every day) for a maximum score of 27, higher number indicating worse outcome

  baseline, mid-treatment(5 weeks after baseline) , post-treatment (12 weeks after baseline), 3 month follow up, 6 month follow up

Secondary Outcomes (4)

• Change in caregiver burden as assessed by the Rapid Screen for Caregiver Burden (CBI)

  baseline, mid treatment (5 weeks after baseline) , post-treatment (12 weeks after baseline), 3 month follow up, 6 month follow up

• Change in efficacy of coping with life's challenges as assessed by the Coping Self-Efficacy Scale (CSES)

  baseline, mid treatment (5 weeks after baseline) , post-treatment (12 weeks after baseline),3 month follow up, 6 month follow up

• Change in stress as assessed by the Riverside Acculturation Stress Inventory (RASI)

  baseline, mid treatment (5 weeks after baseline) , post-treatment (12 weeks after baseline), 3 month follow up, 6 month follow up

• Change in goal attainment Goal Attainment Scaling (GAS)

  week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10, week 11, week 12

Study Arms (1)

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

EXPERIMENTAL

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

Interventions

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

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

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• UTHealth Houston Seed Grant and Autism Speaks Fellowship: collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Antonio Pagan, PhD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral Research Fellow

Study Record Dates

• First Submitted: October 22, 2023
• First Posted: October 30, 2023
• Study Start: April 1, 2024
• Primary Completion: November 1, 2025
• Study Completion: December 31, 2025
• Last Updated: August 27, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)