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)

Overview

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

Interventions

• Behavioral CLS-A-FUERTE
  CLS-A-FUERTE Intervention Description: The CLS-A-FUERTE program is a school clinician training and psychosocial intervention program designed to improve attention and behavior in Mexican school-aged youth (grades 1-5). Participating school clinicians are supported by a clinical research team of trainers who co-leads weekly training/consultation meetings and observes each intervention component (i.e., 6 weekly parent and student skills groups, as well as classroom management in the form of a Dail

Primary outcome measures

• Change in Child Symptom Inventory-4 (CSI-4) Parent Checklist ADHD Combined type Symptom Severity Score [Time frame: Baseline and post treatment (8 weeks) and follow-up (3 months)]
• Change in Child Symptom Inventory-4 (CSI-4) Teacher Checklist ADHD Combined type Symptom Severity Score [Time frame: Baseline and post treatment (8 weeks) and follow-up (3 months)]

Secondary outcome measures (4)

• Change in Child Symptom Inventory-4 (CSI-4) Parent Checklist (Oppositional Defiant Disorder) ODD Symptom Severity Score [Time frame: Baseline and post treatment (8 weeks) and follow-up (3 months)]
• Change in Child Symptom Inventory-4 (CSI-4) Teacher Checklist (Oppositional Defiant Disorder) ODD Symptom Severity Score [Time frame: Baseline and post treatment (8 weeks) and follow-up (3 months)]
• Change Impairment Rating Scale (IRS) Parent Questionnaire Overall Severity Score [Time frame: Baseline and post treatment (8 weeks) and follow-up (3 months)]
• Change Impairment Rating Scale (IRS) Teacher Questionnaire Overall Severity Score [Time frame: Baseline and post treatment (8 weeks) and follow-up (3 months)]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Health services research

Study locations

Mexico · 2 centers

• Benemérita Universidad Autónoma de Puebla — Puebla City
• Universidad Autonoma de Sinaloa — Culiacán

United States · 1 center

• UCSF — San Francisco

Identifiers

NCT: NCT06457256 · CLS-A-FUERTE

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗