Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06457256
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-06-07
Brief Title:
Hybrid Effectiveness-Implementation Trial of a School Clinician Training and Psychosocial ADHDODD Intervention Program Adapted for Schools Across Mexico
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Hybrid Effectiveness-Implementation Trial of a School Clinician Training and Psychosocial ADHDODD Intervention Program Adapted for Schools Across Mexico CLS-A-FUERTE
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CLS-A-FUERTE
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 ADHDODD intervention ie 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 barriersfacilitators 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 schools needsresources ie 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 ADHDODD 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 andor 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 ADHDODD 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 andor 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 ie cost estimates and acceptability ie 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 ie presentations papers grants H9 Show improved EBT skills research capacity and culture ratings and competency as program trainers
H1 School clinicians will engage in training and implement chosen intervention components with fidelity H2 Teachers andor 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 ADHDODD 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 andor 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 ie cost estimates and acceptability ie 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 ie presentations papers grants H9 Show improved EBT skills research capacity and culture ratings and competency as program trainers
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None