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

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ClinicalTrials.gov Identifier: NCT02888821
Recruitment Status : Enrolling by invitation
First Posted : September 5, 2016
Last Update Posted : December 13, 2018
Sponsor:
Information provided by (Responsible Party):
Lauren Haack, University of California, San Francisco

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
ADHD Behavioral: CLS-FUERTE Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 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 : August 2016
Actual Primary Completion Date : July 2017
Estimated Study Completion Date : July 2019

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.

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.




Primary Outcome Measures :
  1. 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).

  2. 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).


Secondary Outcome Measures :
  1. 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).



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Ages Eligible for Study:   5 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Additional Information:
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Responsible Party: Lauren Haack, Clinical Psychology Fellow, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02888821     History of Changes
Other Study ID Numbers: 16-19845
First Posted: September 5, 2016    Key Record Dates
Last Update Posted: December 13, 2018
Last Verified: December 2018