School-Home Program for Mexican Children With Attention and Behavioral Concerns
Phase: NA
Conditions: ADHD
Sponsor: University of California, San Francisco

 
 
 
 
 
School-Home Program for Mexican Children with Attention and Behavioral Concerns 
 
NCT number: NCT02888821 
 
Document Date: 08/25/2021 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
Study Protocol 
Participants 
A total of N = 58 Mexican students in grades 1-5 across eight public elementary schools in 
Sinaloa, Mexico participated in the current study (M = 7.25 students/school, range = 6-8). For each 
student, one parent and one teacher were designated as “primary” (meaning they would participate in 
CLS-FUERTE and implement the strategies) and asked to complete all measures. All data was collected 
at the students’ respective schools. See Table 2 for demographic information and Figure 1 for participant 
flow. 
Recruitment. Recruitment occurred between May and September each year and began with 
invitations to school principals suggested by the local SEP. As described in the introduction, as part of our 
augmented outreach/recruitment plan for Mexico, we invited all families and personnel in participating 
schools to an informational gathering in September in which we showed a silent video depicting a child 
with attention and impulse-control difficulties (i.e., the Behavioral Impairment Video; Haack, Gerdes, 
Lawton, & Schneider, 2014). We encouraged families to contact us if interested in a program to help 
children similar to the child in the video. School personnel also identified candidate children and 
contacted families about participating. See Figure 1 for recruitment flow and number of students deemed 
ineligible at each step of recruitment. 
Screening. Interested parents scheduled an appointment to screen for eligibility. If parents 
attended the screening appointment, reported willingness/ability to participate in sessions, and described 
at least six youth symptoms of inattention and/or hyperactivity with at least one area of related 
impairment (i.e., school, family, or social impairment), we scheduled meetings for baseline assessments.  
Baseline Assessment. After completing informed consent procedures approved by UCSF 
Committee on Human Research, parents and teachers of successfully screened students completed 
questionnaires, including the Child Symptom Inventory (CSI-4; Gadow & Sprafkin, 1997), Impairment 
Rating Scale (IRS; Fabiano et al., 2006), and demographic/history form. Students meeting the following 
criteria were eligible to participate: (a) at least six CSI-4 inattention symptoms and/or six 

 
hyperactive/impulsive symptoms endorsed by parent or teacher as occurring often or very often, (b) at 
least one area of IRS functioning rated as ≥ 3 by both parent and teacher, thereby indicating cross-setting 
impairment, (c) a parent available to participate; and (d) a primary teacher agreeing to participate. The 
assessment and screening algorithm based on at least six symptoms per domain reported by parents or 
teachers has been used in previous school-based ADHD trials (Haack et al., 2018; Pfiffner et al., 2016) 
and is associated with strong predictive validity for ADHD (sensitivity = .80, specificity = .58; Gadow & 
Sprafkin, 2002) and ODD (sensitivity = .70, specificity = .90; Gadow & Sprafkin, 2002) diagnoses. 
Students taking medication were eligible as long as regimens were stable. Students with significant visual 
or hearing impairments, severe language delay, psychosis, or pervasive developmental disorder or who 
were in full-day special classrooms were excluded. Eligible students provided assent before participating.  
Study Design  
A 2-level (students, schools) cluster RCT design (Hayes & Moulton, 2009) accounted for 
treatment (CLS-FUERTE or BAU) within level 2 (schools). We randomized schools to CLS-FUERTE 
(school n = 4, student n = 28) or BAU (school n = 4, student n = 31). We determined our sample size 
based on practical considerations (i.e., previous CLS trial experience, years of funding). Each year, 
schools were divided into high or low Socioeconomic Status (SES) categories (determined by the 
Secretary of Public Education; SEP) after baseline assessments were completed in September. The first 
author coded schools to conceal their identity until treatment was assigned and a statistician randomized 
concealed ordered pairs to CLS-FUERTE or BAU using a random number generator. Those randomized 
to CLS-FUERTE received the intervention between October and December, followed by post assessments 
for all families in December each year. 
Intervention: CLS-FUERTE 
 
The CLS-FUERTE program is a comprehensive psychosocial treatment for school-aged youth 
(grades 1-5) delivered by Mexican School Mental Health Professionals (SMHPs) directly at the students’ 
school site. The six-week program encompasses weekly parent management training groups led by the 
SMHP, weekly student skills groups led by the SMHP, and daily classroom management by the teacher 

 
supported by the SMHP. The program is designed to teach parents, students, and teachers a common 
language encouraging skill use to address impairment related to ADHD and ODD. Thus, students in CLS-
FUERTE receive around-the-clock prompting and reinforcement for goal behaviors related to school, 
family, and social functioning. 
Parent component. Parents attended six 90-minute groups teaching strategies to manage 
attention/behavior challenges including positive consequences (e.g., rewards, praise), negative 
consequences (e.g., planned ignoring, removing privileges), and routines. Each group, SMHPs reviewed 
and troubleshooted strategies assigned and presented new strategies. Parents also reviewed skills covered 
in the student group and were taught methods to promote and reinforce skill generalization. Groups were 
held at school sites and scheduled to accommodate participating families, often after drop-off.  
Child component. Students attended six 60-minute groups teaching strategies to compensate for 
attention/behavioral challenges, including organization (e.g., routines) and social skills (e.g., good 
sportsmanship, handling teasing). SMHPs targeted skill knowledge and implementation through didactic 
instruction, modeling, behavioral rehearsal via interactive games, corrective feedback, and in-vivo 
practice via role plays. Students received reinforcement (i.e., praise, tickets called “stars”, small prizes) 
for following rules, participating in activities, and practicing skills. Self-management of alertness was 
targeted with group-reinforced attention checks (Pelham Jr. & Hoza, 1996). To encourage skill 
generalization, students brought in “stars” they earned at home and class to exchange for praise and a 
group-based reward (i.e., celebratory party). Groups occurred during the school day at students’ 
respective schools; groups were scheduled by the SMHPs based on the collective input they received 
from participating teachers regarding the most suitable day and time for children to attend group, usually 
during a nonacademic period. 
Classroom component. Teachers attended a 60-minute orientation, during which SMHPs 
provided an overview of attention/behavior concerns and the use of a school–home daily report card 
(DRC). Teachers selected two or three behavior goals tailored for each student, which were discussed 
with the parent and student during a 15 to 30-minute meeting. Behavior goals could include academic 

 
targets (e.g., gets started on work right away, completes work accurately) or social-emotional targets (e.g., 
keeps hands/feet to self, asks for help when needed). Teachers rated each behavior up to three times per 
school day on a 3-point scale (0= goal not met, 1=needs improvement, 2=goal met). Students were 
prompted to bring their DRC home daily to exchange points for rewards. Skills taught in the student 
groups were shared with teachers to promote cross-setting reinforcement and generalization. 
 
SMHP Training, consultation, and fidelity monitoring. SMHPs in the Sinaloa school district 
have bachelor’s or master’s degrees in education but are not consistently required to receive training or 
observation in EBTs (Sanchez‐Sosa, 2007; Stark et al., 2010). Typically, they are assigned caseloads of 
students with mental health disorders (approximately 20 students per caseload with a maximum of 25 
students). SMHPs are provided a manual which contains information for educating youth with mental 
health disorders but lacks presentation of any specific strategies (The New Mexican School, 2019). We 
recruited SMHPs in the current study via their school principals. Each SMHP was assigned a member of 
our team as their primary trainer. To enhance consistency in training and feedback, each SMHP’s primary 
trainer led (or co-led) their initial training and consultation meetings, as well as attended each session.   
Each participating SMHP attended an initial 8-hour training with their trainer to learn 
psychoeducation about attention/behavior challenges and the principles supporting psychosocial 
ADHD/ODD intervention (such as structuring antecedents and providing reinforcement to encourage goal 
behaviors), learn and practice behavior management strategies to employ during meetings and groups 
(e.g., attention checks, differential reinforcement), as well as learn and practice the first meetings of each 
component (i.e., the first parent group, the first student group, the teacher orientation and the teacher-
family-student DRC meeting). Each week during the program, SMHPs attended 60-90 minute 
consultation meetings with their trainer to review upcoming manual content, role-play key content, and 
troubleshoot problems. SMHPs were provided a detailed, scripted manual for each component. In the 
initial training and weekly consultation meetings, trainers modeled intervention delivery, presented video 
clips of previous SMHPs delivering the intervention, and guided SMHPs in role-playing the intervention 
delivery.  

 
Each parent, child, and classroom component session was led by SMHPs with in-vivo 
observation from their trainer to rate fidelity/engagement and answer questions or provide modeling of 
the curriculum as needed. Specifically, trainers monitored how much of the scripted manual content 
SMHPs delivered in each session, as well as the quality of SMHP delivery, including clarity in presenting 
each skill, effectiveness in responding to questions, use of group management strategies to maintain 
balance of participant involvement and enhance engagement, and use of time management strategies. 
Trainers also rated each participant’s attendance and engagement in the session. Trainers provided 
prompting or modeling as needed to ensure accurate delivery of content, improve group implementation 
quality, and/or enhance participant engagement. Fidelity ratings were reviewed in weekly consultation 
meetings and strategies were discussed and practiced as needed to improve SMHP fidelity and participant 
engagement in future meetings. 
BAU Condition. Those assigned to BAU received school services as usual. These services 
typically included tutoring with SMHPs. Of note, those in CLS-FUERTE also continued to receive school 
services as usual throughout the intervention period. After post assessments were completed (which 
occurred at the same time in both treatment conditions), BAU families were invited to receive CLS-
FUERTE and BAU SMHPs were trained to implement the program.  
 
Data Analytic Approach  
We performed all statistical analyses using SPSS (Version 26; IBM Corp, 2019). We analyzed 
outcomes in three domains (i.e., ADHD and ODD symptoms, and overall impairment) separately for each 
rater (i.e., parent and teacher). Primary analyses involved generalized estimating equations (GEE) using 
the SPSS GENLIN procedure with unstructured correlation matrices to examine within (baseline; post-
treatment) and between (CLS-FUERTE vs BAU) group comparisons, adjusting for school clustering. 
GEE was chosen over alternative methods due to relaxed distribution requirements. Analyses were 
completed initially without covariates. We then performed follow-up analyses adjusting for parental level 
of education and child age, gender, and ADHD medication status; however, inclusion did not change the 
pattern or interpretation of results. Therefore, simple analyses without covariates are presented. To control 

 
for Type 1 Error, a Benjamini-Hochberg false discovery rate (FDR; Benjamini & Hochberg, 1995) was 
applied within domain. The FDR exerts a more powerful control over wrongly rejecting the null 
compared to other procedures that control for family-wise error (e.g., Bonferroni correction). For all 
pairwise comparisons, Hedges’ g effect size metrics are provided. Hedges’ g estimates are Cohen’s d 
estimates corrected for the upward bias associated with smaller sample sizes. Interpretation of Hedges’ g 
estimates are consistent with traditional effect size conventions (i.e., 0.2 = small; 0.5 = moderate; 0.8 = 
large).