Clinical trial NCT06107972: Developing a Culturally Adapted Intervention for Latino Youth Transitioning to Adulthood
Official title: Developing a Culturally Adapted Intervention for Latino Youth Transitioning to Adulthood
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: UTHealth Houston Seed Grant and Autism Speaks Fellowship
First posted: 2023-10-30
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 (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.

Primary outcomes:
measure: Change in adaptive behavior as assessed by the Adaptive Behaviour Assessment System, Third Edition
timeFrame: baseline, mid-treatment (5 weeks after baseline) , post-treatment (12 weeks after baseline), 3 month follow up, 6 month follow up
measure: Change in Quality of life as assessed by the Autism Spectrum Quality of Life (ASQoL) questionnaire
timeFrame: baseline, mid-treatment (5 weeks after baseline) , post-treatment (12 weeks after baseline), 3 month follow up, 6 month follow up
measure: Change in Anxiety as assessed by the Generalized Anxiety Disorder-7 (GAD7)
timeFrame: baseline, mid-treatment(5 weeks after baseline) , post-treatment (12 weeks after baseline), 3 month follow up, 6 month follow up
measure: Change in depression as assessed by the Patient Health Questionnaire (PHQ-9)
timeFrame: baseline, mid-treatment(5 weeks after baseline) , post-treatment (12 weeks after baseline), 3 month follow up, 6 month follow up
Secondary outcomes:
measure: Change in caregiver burden as assessed by the Rapid Screen for Caregiver Burden (CBI)
timeFrame: baseline, mid treatment (5 weeks after baseline) , post-treatment (12 weeks after baseline), 3 month follow up, 6 month follow up
measure: Change in efficacy of coping with life's challenges as assessed by the Coping Self-Efficacy Scale (CSES)
timeFrame: baseline, mid treatment (5 weeks after baseline) , post-treatment (12 weeks after baseline),3 month follow up, 6 month follow up
measure: Change in stress as assessed by the Riverside Acculturation Stress Inventory (RASI)
timeFrame: baseline, mid treatment (5 weeks after baseline) , post-treatment (12 weeks after baseline), 3 month follow up, 6 month follow up
measure: Change in goal attainment Goal Attainment Scaling (GAS)
timeFrame: week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10, week 11, week 12
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Antonio Pagan, PhD
role: PRINCIPAL_INVESTIGATOR
References: