Clinical trial NCT06457256: Hybrid Effectiveness-Implementation Trial of a School Clinician Training and Psychosocial ADHD/ODD Intervention Program Adapted for Schools Across Mexico
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)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: ADHD
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Fogarty International Center of the National Institute of Health
First posted: 2024-06-13
Enrollment: 872
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: School Services as Usual (SAU) waitlist design
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Change in Child Symptom Inventory-4 (CSI-4) Parent Checklist ADHD Combined type Symptom Severity Score
timeFrame: Baseline and post treatment (8 weeks) and follow-up (3 months)
measure: Change in Child Symptom Inventory-4 (CSI-4) Teacher Checklist ADHD Combined type Symptom Severity Score
timeFrame: Baseline and post treatment (8 weeks) and follow-up (3 months)
Secondary outcomes:
measure: Change in Child Symptom Inventory-4 (CSI-4) Parent Checklist (Oppositional Defiant Disorder) ODD Symptom Severity Score
timeFrame: Baseline and post treatment (8 weeks) and follow-up (3 months)
measure: Change in Child Symptom Inventory-4 (CSI-4) Teacher Checklist (Oppositional Defiant Disorder) ODD Symptom Severity Score
timeFrame: Baseline and post treatment (8 weeks) and follow-up (3 months)
measure: Change Impairment Rating Scale (IRS) Parent Questionnaire Overall Severity Score
timeFrame: Baseline and post treatment (8 weeks) and follow-up (3 months)
measure: Change Impairment Rating Scale (IRS) Teacher Questionnaire Overall Severity Score
timeFrame: Baseline and post treatment (8 weeks) and follow-up (3 months)
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF
state: California
city: Puebla De Zaragoza
country: Mexico
facility: Benemérita Universidad Autónoma de Puebla
state: Puebla
city: Culiacán
country: Mexico
facility: Universidad Autonoma de Sinaloa
state: Sinaloa
Study officials:
affiliation: University of California, San Francisco
name: Lauren Haack, PhD
role: PRINCIPAL_INVESTIGATOR
References: