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NCT Number: NCT06457256

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

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.

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Key information

Conditions

ADHD Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

5 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Benemérita Universidad Autónoma de Puebla, Puebla City, Puebla, Mexico

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

CLS-A-FUERTE

Behavioral

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 Daily Report Card) in-vivo via videoconferencing.

Primary outcomes

  1. 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)

    Parents will assess ADHD symptoms using the CSI-4. The CSI-4: Parent Checklist contains 18 symptoms for ADHD, Combined type (ADHD:C; 18 items). Each symptom is rated on a 4-point scale (0= never to 3= very often). The average of ADHD:C scores range from zero to four, with higher scores indicating more severe symptoms.

  2. 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)

    Teachers will assess ADHD symptoms using the CSI-4. The CSI-4: Teacher Checklist contains 18 symptoms for ADHD, Combined type (ADHD:C; 18 items). Each symptom is rated on a 4-point scale (0= never to 3= very often). The average of ADHD:C scores range from zero to four, with higher scores indicating more severe symptoms.

Secondary outcomes

  1. 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)

    Parents will assess ODD symptoms using the CSI-4. The CSI-4: Parent Checklist contains 9 symptoms of ODD. Each symptom is rated on a 4-point scale (0= never to 3= very often). The average ODD scores range from zero to four, with higher scores indicating more severe symptoms.

  2. 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)

    Teachers will assess ODD symptoms using the CSI-4. The CSI-4: Teacher Checklist contains 9 symptoms of ODD. Each symptom is rated on a 4-point scale (0= never to 3= very often). The average ODD scores range from zero to four, with higher scores indicating more severe symptoms.

  3. Change Impairment Rating Scale (IRS) Parent Questionnaire Overall Severity Score

    Time frame: Baseline and post treatment (8 weeks) and follow-up (3 months)

    Parents will assess impairment using the IRS. The IRS Parent Questionnaire contains 8 items of functional impairment (i.e., academic and peer relations). Each item is rated on a 7-point scale (1= no problem; does not need treatment/services to 7= extreme impairment; definitely needs treatment/services). The average of all IRS scores range from one to seven, with higher scores indicating more severe impairment.

  4. Change Impairment Rating Scale (IRS) Teacher Questionnaire Overall Severity Score

    Time frame: Baseline and post treatment (8 weeks) and follow-up (3 months)

    Teachers will assess impairment using the IRS. The IRS Teacher Questionnaire contains 8 items of functional impairment (i.e., academic and peer relations). Each item is rated on a 7-point scale (1= no problem; does not need treatment/services to 7= extreme impairment; definitely needs treatment/services). The average of all IRS scores range from one to seven, with higher scores indicating more severe impairment.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Fogarty International Center of the National Institute of Health

Registry information

Official study title

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

Acronym: (CLS-A-FUERTE)

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Jun 13, 2024
Registry last updated
Aug 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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