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

NCT02888821 | Completed

• 1 other identifier: 16-19845
• Study Type: interventional
• Target: 58
• Locations: 0 countries
• Sites: N/A

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.

Conditions

ADHD

Outcome Measures

Primary Outcomes (2)

• 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)

• 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Rating Scale \[IRS\] by Fabiano et al., 2006; the ADHD-FX by Haack et al., 2014; and the FX-II by Haack et al., unpublished).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 Outcomes (1)

• Executive Functioning Change

  Change measured 3 times (i.e., from baseline at 3, 6, and 8 months)

Study Arms (2)

CLS-FUERTE

EXPERIMENTAL

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

Business as Usual (BAU) Waitlist Control

OTHER

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

Interventions

CLS-FUERTE BEHAVIORAL

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; CLS-FUERTE

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Inability of caretakers or teachers to attend groups and meetings.

Sponsors & Collaborators

• University of California, San Francisco: lead

Related Links

• original CLS intervention efficacy study

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2016
• First Posted: September 5, 2016
• Study Start: August 1, 2016
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: October 14, 2021

Record last verified: 2021-10