School-Home Program for Mexican Children With Attention and Behavioral Concerns (CLS-FUERTE)
Primary Purpose
ADHD
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CLS-FUERTE
Sponsored by
About this trial
This is an interventional treatment trial for ADHD
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
CLS-FUERTE
Business as Usual (BAU) Waitlist Control
Arm Description
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.
Families will receive school services as usual while on a waitlist to receive CLS-FUERTE in the spring of the 2016-2017 school year.
Outcomes
Primary Outcome Measures
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).
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Rating Scale [IRS] by Fabiano et al., 2006; the ADHD-FX by Haack et al., 2014; and the FX-II by Haack et al., unpublished).
Secondary Outcome Measures
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).
Full Information
NCT ID
NCT02888821
First Posted
August 9, 2016
Last Updated
October 5, 2021
Sponsor
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT02888821
Brief Title
School-Home Program for Mexican Children With Attention and Behavioral Concerns
Acronym
CLS-FUERTE
Official Title
School-Home Program for Mexican Children With Attention and Behavioral Concerns
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
August 2016 (Actual)
Primary Completion Date
July 2019 (Actual)
Study Completion Date
July 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADHD
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CLS-FUERTE
Arm Type
Experimental
Arm Description
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.
Arm Title
Business as Usual (BAU) Waitlist Control
Arm Type
Other
Arm Description
Families will receive school services as usual while on a waitlist to receive CLS-FUERTE in the spring of the 2016-2017 school year.
Intervention Type
Behavioral
Intervention Name(s)
CLS-FUERTE
Intervention Description
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.
Primary Outcome Measure Information:
Title
ADHD Symptoms Change
Description
via parent and teacher rated questionnaire (i.e., the Child Symptom InventCLS-FUERTE completion), and Time 4 (end of the school year).
Time Frame
Change in ADHD symptoms measured 3 times (i.e., from baseline at 3, 6, and 8 months)
Title
ADHD Impairment Change
Description
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).
Time Frame
measured 3 times (i.e., from baseline at 3, 6, and 8 months)
Secondary Outcome Measure Information:
Title
Executive Functioning Change
Description
via parent and teacher rated questionnaire (i.e., the Behavior Rating Inventory of Executive Functioning-2 [BRIEF] by Gioia et al., 2000).
Time Frame
Change measured 3 times (i.e., from baseline at 3, 6, and 8 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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.
12. IPD Sharing Statement
Links:
URL
http://dx.doi.org/10.1016/j.jaac.2016.05.023
Description
original CLS intervention efficacy study
Learn more about this trial
School-Home Program for Mexican Children With Attention and Behavioral Concerns
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