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School-Home Program for Mexican Children With Attention and Behavioral Concerns

School-Home Program for Mexican Children With Attention and Behavioral Concerns

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02888821
Acronym
CLS-FUERTE
Enrollment
58
Registered
2016-09-05
Start date
2016-08-31
Completion date
2019-07-31
Last updated
2021-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ADHD

Brief summary

A school-based behavioral intervention for Mexican youth with attention/behavior concerns (the Collaborative Life Skills Program for Latinos/Familias Unidades Empezando Retos y Tareas para el Éxito \[CLS-FUERTE\]:) will be pilot-tested in a mixed-method investigation with four Mexican elementary schools.

Detailed description

A school-based behavioral intervention for Mexican youth with attention/behavior concerns (the Collaborative Life Skills Program for Latinos/Familias Unidades Empezando Retos y Tareas para el Éxito \[CLS-FUERTE\]:) will be pilot-tested in a mixed-method investigation with four Mexican elementary schools. Participants will include 24-32 students (n = 6-8 per 4 schools) in participating schools. School personnel will help identify students with and at-risk for Attention-Deficit/Hyperactivity Disorder (ADHD) with at least one caretaker and teacher able to participate in the intervention. Students must be in 1st-6th grade at a participating school and must demonstrate clinically significant attention/behavioral concerns and related impairment as rated by caretakers and teachers. Caretakers and teachers must be able to attend program sessions held at the child's school over an approximately 6-week period. Through a school-clustered random assignment design, two schools will be selected to receive CLS-FUERTE during the fall of the 2016-2017 school year and two schools will be selected to receive school services as usual while waiting to receive CLS-FUERTE the spring of the 2016-2017 school year. Caregivers and teachers of students will complete questionnaires about child behavior and family functioning and caregivers will participate in focus groups at 4 time points regardless of treatment assignment: Pre (prior to random assignment), Post 1 (following CLS-FUERTE in the fall cohort), Post 2 (following CLS-FUERTE for in spring cohort), and Follow-up (at the end of the school year). Feasibility and acceptability of CLS-FUERTE will be examined via participation enrollment, attendance, and engagement ratings and focus group feedback. Improvement in satisfaction with school services and youth outcomes will be examined and estimates of effect sizes will be used to support future scaled-up investigation.

Interventions

BEHAVIORALCLS-FUERTE

The CLS-FUERTE program is an approximately 6-week program and includes school (behavioral consultation with teachers), caretaker (caretaker skills groups), and student (skills groups) components which are integrated via joint teacher, parent, and student meetings and use of integrated behavioral programs in the classroom, on the playground, and at home.

Sponsors

University of California, San Francisco
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
5 Years to 12 Years
Healthy volunteers
No

Inclusion criteria

* Caretakers and teachers of children must each describe at least 3 symptoms of ADHD as occurring often or very often, as well as 1 impairment domain of ADHD as affecting the child quite a bit or a lot on a symptom screening interview.

Exclusion criteria

* Inability of caretakers or teachers to attend groups and meetings.

Design outcomes

Primary

MeasureTime frameDescription
ADHD Symptoms ChangeChange in ADHD symptoms measured 3 times (i.e., from baseline at 3, 6, and 8 months)via parent and teacher rated questionnaire (i.e., the Child Symptom InventCLS-FUERTE completion), and Time 4 (end of the school year).
ADHD Impairment Changemeasured 3 times (i.e., from baseline at 3, 6, and 8 months)via parent and teacher rated questionnaire (i.e., the Impairment Rating Scale \[IRS\] by Fabiano et al., 2006; the ADHD-FX by Haack et al., 2014; and the FX-II by Haack et al., unpublished).

Secondary

MeasureTime frameDescription
Executive Functioning ChangeChange measured 3 times (i.e., from baseline at 3, 6, and 8 months)via parent and teacher rated questionnaire (i.e., the Behavior Rating Inventory of Executive Functioning-2 \[BRIEF\] by Gioia et al., 2000).

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026