Clinical trial NCT02888821: School-Home Program for Mexican Children With Attention and Behavioral Concerns
Official title: School-Home Program for Mexican Children With Attention and Behavioral Concerns
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ADHD
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2016-09-05
Enrollment: 58
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: ADHD Symptoms Change
timeFrame: Change in ADHD symptoms measured 3 times (i.e., from baseline at 3, 6, and 8 months)
measure: ADHD Impairment Change
timeFrame: measured 3 times (i.e., from baseline at 3, 6, and 8 months)
Secondary outcomes:
measure: Executive Functioning Change
timeFrame: Change measured 3 times (i.e., from baseline at 3, 6, and 8 months)
Other outcomes:
Locations:
Study officials:
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