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

ADHD Clinical Trial

— CLS-FUERTE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02888821
• Other study ID #: 16-19845
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: July 2019

Study information

• Verified date: October 2021
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: July 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• ADHD
• Problem Behavior

Intervention

Behavioral:
• CLS-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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ADHD Symptoms Change	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)
Primary	ADHD Impairment Change	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	Executive Functioning Change	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)

External Links

•   original CLS intervention efficacy study