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

Sponsor
University of California, San Francisco (Other)
Overall Status
Completed
CT.gov ID
NCT02888821
Collaborator
(none)
58
2
35

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: CLS-FUERTE
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
58 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
School-Home Program for Mexican Children With Attention and Behavioral Concerns
Actual Study Start Date :
Aug 1, 2016
Actual Primary Completion Date :
Jul 1, 2019
Actual Study Completion Date :
Jul 1, 2019

Arms and Interventions

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.

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.

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.

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.

Outcome Measures

Primary Outcome Measures

  1. ADHD Symptoms Change [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).

  2. ADHD Impairment Change [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).

Secondary Outcome Measures

  1. Executive Functioning Change [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
5 Years to 12 Years
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of California, San Francisco

Investigators

None specified.

Study Documents (Full-Text)

More Information

Additional Information:

Publications

None provided.
Responsible Party:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT02888821
Other Study ID Numbers:
  • 16-19845
First Posted:
Sep 5, 2016
Last Update Posted:
Oct 14, 2021
Last Verified:
Oct 1, 2021
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 14, 2021