Summary

Eligibility
for people ages 5 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around
Principal Investigator
by Lauren Haack, PhD
Headshot of Lauren Haack
Lauren Haack

Description

Summary

Neurodevelopmental disorders of Attention-Deficit/ Hyperactivity Disorder (ADHD) and Oppositional Defiant Disorder (ODD) are extremely common but underserved with Evidence- Based Treatments (EBT) worldwide. Thus, a school clinician training and ADHD/ODD intervention (i.e., the Collaborative Life Skills [CLS] program) was developed, implemented and evaluated for Mexico: a setting with high unmet need. Technology was integrated into the in-person program (CLS-FUERTE) to create a digitally enhanced version (CLS-R-FUERTE). Given findings demonstrating feasibility, acceptability, and efficacy of both program versions, a Type 2 Hybrid Effectiveness-Implementation Design will be applied to evaluate the program effectiveness, mechanisms of intervention change, and maintenance barriers/facilitators in a scaled-up cluster randomized controlled trial across two Mexican states -while simultaneously exploring an implementation strategy in which the program is adapted to enhance maintenance given each school's needs/resources (i.e., CLS-A-FUERTE). The implementation process is guided by the Exploration, Preparation, Implementation, and Sustainment (EPIS) model with evaluation following the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) Framework.

Official Title

Hybrid Effectiveness-Implementation Trial of a School Clinician Training and Psychosocial ADHD/ODD Intervention Program Adapted for Schools Across Mexico (CLS-A-FUERTE)

Details

Aim 1) Test the effectiveness and implementation of the CLS-A-FUERTE school clinician training and ADHD/ODD intervention program adapted for schools across Mexico. It is predicted:

H1) School clinicians will engage in training and implement chosen intervention components with fidelity H2) Teachers and/or families will engage in chosen intervention components and adhere to the strategies H3) Students receiving the CLS-A-FUERTE intervention will show greater improvements in ADHD/ODD symptoms and associated impairment compared to students receiving school services as usual

Aim 2) Evaluate mechanisms of sustained intervention change. It is predicted:

H4) Improvements in parenting behaviors will mediate sustained intervention effects H5) Improvements in teacher and/or school clinician competency will mediate intervention effects

Aim 3) Identify CLS-A-FUERTE maintenance barriers and facilitators. It is predicted that sustained intervention effects and continuation of program activities at follow-up will relate to:

H6) Program feasibility (i.e., cost estimates) and acceptability (i.e., participant satisfaction) H7) Characteristics of participating schools and school context factors

Aim 4) Expand research capacity to a novel university setting. It is predicted that emerging investigators will:

H8) Complete clinical research coursework and produce deliverables (i.e., presentations, papers, grants) H9) Show improved EBT skills, research capacity and culture ratings, and competency as program trainers

Keywords

ADHD, CLS-A-FUERTE

Eligibility

You can join if…

Open to people ages 5 years and up

  • must demonstrate at least six inattention symptoms and/or six hyperactive/impulsive symptoms endorsed by parent or teacher as occurring often or very often, AND at least one area of impairment rated as concerning by both parent and teacher, AND have a parent and teacher agreeing to participate (for student participants)
  • Must be a parents, teacher, or school clinicians of participating students (for parent, teacher, and school clinician participants)
  • Must be a university student in psychology or education at UAS or BUAP (for emerging investigator/university student participants)

You CAN'T join if...

  • inability to speak and read Spanish
  • unstable medication regimen (for student participants)
  • severe visual or hearing impairment (for student participants)
  • severe language delay (for student participants)
  • psychosis (for student participants)
  • Placement in an all-day special education classroom (for student participants)

Locations

  • UCSF
    San Francisco California 94104 United States
  • Universidad Autonoma de Sinaloa
    Culiacán Sinaloa 80050 Mexico
  • Benemérita Universidad Autónoma de Puebla
    Puebla De Zaragoza Puebla 72000 Mexico

Lead Scientist at UCSF

  • Lauren Haack, PhD
    Lauren M. Haack, PhD, is an associate professor and attending psychologist with research and focused on 1) cultural influences to mental health conceptualization, assessment, and treatment, 2) accessible and culturally attuned evidence-based services for traditionally underserved youth and families worldwide, and 3) provider experience, training, and consultation.

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT06457256
Study Type
Interventional
Participants
Expecting 1000 study participants
Last Updated