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Clinical Trials/NCT06107972
NCT06107972
Active, not recruiting
Not Applicable

Developing a Culturally Adapted Intervention for Latino Youth Transitioning to Adulthood

The University of Texas Health Science Center, Houston1 site in 1 country56 target enrollmentApril 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Autism Spectrum Disorder
Sponsor
The University of Texas Health Science Center, Houston
Enrollment
56
Locations
1
Primary Endpoint
Change in adaptive behavior as assessed by the Adaptive Behaviour Assessment System, Third Edition
Status
Active, not recruiting
Last Updated
8 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2024
End Date
December 31, 2025
Last Updated
8 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Antonio Pagan

Postdoctoral Research Fellow

The University of Texas Health Science Center, Houston

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.

Outcomes

Primary Outcomes

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

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

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

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

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

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

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

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

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

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

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

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

Secondary Outcomes

  • 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 Sites (1)

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