School-Home Program for Mexican Children With Attention and Behavioral Concerns (CLS-FUERTE)
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: CLS-FUERTE
Families will receive the CLS-FUERTE intervention in the fall of the 2016-2017 school year.
CLS-FUERTE includes caretaker, child and teacher components implemented during a 6 week period.
All content of group sessions will be derived from the manualized CLS-FUERTE treatment protocol developed by the PI and study staff.
|
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.
|
|
OTHER: Business as Usual (BAU) Waitlist Control
Families will receive school services as usual while on a waitlist to receive CLS-FUERTE in the spring of the 2016-2017 school year.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
ADHD Symptoms Change
Time Frame: Change 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).
|
Change in ADHD symptoms measured 3 times (i.e., from baseline at 3, 6, and 8 months)
|
|
ADHD Impairment Change
Time Frame: measured 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).
|
measured 3 times (i.e., from baseline at 3, 6, and 8 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Executive Functioning Change
Time Frame: Change 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).
|
Change measured 3 times (i.e., from baseline at 3, 6, and 8 months)
|
Collaborators and Investigators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16-19845
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