Developing a Culturally Adapted Intervention for Latino Youth Transitioning to Adulthood

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.

Study Overview

• Status: Recruiting
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Behavioral: Launching! to Adulthood (¡Iniciando! la Adultez) 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.

• Study Type: Interventional
• Enrollment (Estimated): 58
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Antonio Pagan, PhD; Phone Number: (713) 486-2700; Email: Antonio.Pagan@uth.tmc.edu
• Study Contact Backup: Name: Katherine Loveland; Phone Number: (713) 486-2587; Email: Katherine.A.Loveland@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas Health Science Center at Houston
      • Contact: Katherine Loveland; Phone Number: (713) 486-2587; Email: Katherine.A.Loveland@uth.tmc.edu
      • Contact: Antonio Pagan, PhD; Phone Number: 713-486-2700; Email: Antonio.Pagan@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 (treatment group only)
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 (10 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 (10 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 (10 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 (10 weeks after baseline), 3 month follow up, 6 month follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in caregiver burden as assessed by the Rapid Screen for Caregiver Burden (CBI)	This is a 24 item questionnaire, each item is given a score between 0 (not at all descriptive) and 4 (very descriptive), where higher scores indicate greater caregiver burden	baseline, mid treatment (5 weeks after baseline) , post-treatment (10 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)	This is a 26 item questionnaire and each is scored on a 11-point scale from 0(cannot do at all)-10 (certain can do) and higher number indicates better outcome	baseline, mid treatment (5 weeks after baseline) , post-treatment (10 weeks after baseline),3 month follow up, 6 month follow up
Change in stress as assessed by the Riverside Acculturation Stress Inventory (RASI)	This is a 15-item scale and each is scored on a 5-point scale ranging from 1 (strongly disagree) to 5 (strongly agree) higher number indicates worse outcome	baseline, mid treatment (5 weeks after baseline) , post-treatment (10 weeks after baseline), 3 month follow up, 6 month follow up
Change in goal attainment Goal Attainment Scaling (GAS)	This is scored on a 5-point scale, with the degree of attainment captured for each goal area: If the patient achieves the expected level, this is scored at 0. If they achieve a better than expected outcome this is scored at: +1 (somewhat better) +2 (much better) If they achieve a worse than expected outcome this is scored at: -1 (somewhat worse) or -2 (much worse) Goals may be weighted to take account of the relative importance of the goal to the individual, and/or the anticipated difficulty of achieving it.	week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: UTHealth Houston Seed Grant and Autism Speaks Fellowship
• Investigators: Principal Investigator: Antonio Pagan, PhD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2023
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): January 31, 2025

Study Registration Dates

• First Submitted: October 22, 2023
• First Submitted That Met QC Criteria: October 25, 2023
• First Posted (Actual): October 30, 2023

Study Record Updates

• Last Update Posted (Estimated): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder
• Other Study ID Numbers: HSC-MS-23-0188

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