Remote School-Home Program to Improve Youth Attention and Behavior in Mexican Students
Phase: NA
Conditions: ADHD, Oppositional Defiant Disorder
Sponsor: University of California, San Francisco

            UNIVERSITY OF CALIFORNIA, SAN FRANCISCO 
 
 
B E RK E L E Y •D A V I S •IRVINE •L O S  A N G E L E S• MERCE D• R I V E R S I D E• SAN DIEGO •SAN F R A N C I S C O                            SANT A BARBARA •SAN TA C R U Z 
 
 
LAUREN M. HAACK, PHD 
 
           NANCY FRIEND PRITZKER BUILDING, ROOM 3445 
ASSOCIATE CLINICAL PROFESSOR, 
 
           675 18TH STREET, SAN FRANCISCO CA 94107 
DEPARTMENT OF PSYCHIATRY AND BEHAVIORAL SCIENCES 
           TELEPHONE: (415) 502-8060 
UNIVERSITY OF CALIFORNIA, SAN FRANCISCO (UCSF) 
 
           EMAIL: lauren.haack@ucsf.edu 
 
 
June 28th, 2024 
  
Principal Investigator: Lauren M. Haack, PhD 
 
Application Title: Adapting a Web-Based Professional Development for Mexican School Mental Health 
Providers Delivering Evidence-Based Intervention for ADHD and ODD (NCT05425966) 
 
Document Date (last approved by the IRB): July 25th 2022 
 
Attachments 
• 
Study Protocol and Statistical Analysis Plan 
 
 
 
Sincerely,   
 
 
 
Lauren M. Haack, PhD 
Principal Investigator 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

STUDY PROTOCOL: A total of N = 64 youth with inattention and disruptive behavior will participate in a 8-
school Randomized Controlled Trial (RCT) evaluating the web-based CLS-R-FUERTE program compared to 
School Services as Usual in the Sinaloa Public School District (i.e., n = 8 youth/school). Youth with 
attention/behavior concerns will be recruited via school-wide meetings at each participating school and 
teacher/school clinician referral. Parents and teachers of youth will provide informed consent and baseline 
ratings of ADHD/ODD; youth will provide assent; and school clinicians will be tested on their evidence based 
practice skills. Half of the schools in each cohort will be randomly assigned to implement the program 
immediately (CLS-R-FUERTE) and the other half will be randomized to wait for the program while 
implementing School Services as Usual (SAU). Next, our team will train school clinicians and monitor fidelity, 
satisfaction and adherence during the 6-week program implementation in CLS-R-FUERTE schools. Then we 
will collect post ratings from all parents/teachers and test school clinicians again. School clinicians, parents, 
and teachers will be compensated $10 each time they complete ratings ($20 total).  
 
CLS-R-FUERTE is a 6-week intervention aimed at reducing attention and behavior symptoms in students. The 
intervention is based on CLS and includes a comprehensive and integrated student, parent and teacher 
component. Students presenting with attention and behavior problems at school sites without the CLS-R-
FUERTE intervention may be referred to the usual care protocol of that school which may include individual 
therapy, social skills groups or referrals to the community.  
 
INCLUSION CRITERIA:  The RCT across 8 schools in the Sinaloa Public School District will include N = 24 
youth with inattention and disruptive behavior (i.e., 8 youth/school; primary study participants); in addition, N = 
8 School Clinicians (i.e., 1 per school), N = 24 parents (i.e., 1 per youth) and N = 24 teachers (i.e., 1 per youth) 
will provide ratings and be involved in the program. School Clinicians at the required N = 8 schools are 
recruited via annual conferences our team has held with the school district describing our preliminary results 
to-date. Youth with attention/behavior concerns in grades 1-5 and their parents/teachers will be recruited via 
school-wide meetings at each participating school and teacher/school clinician referral. This is a procedure 
we’ve used successfully in our previous work in Sinaloa, Mexico. Specifically, we may invite all families and 
personnel at participating schools to a meet-and-greet. In this meet-and-greet, we introduce our study team 
and show a brief silent video depicting a youth with inattention and disruptive behavior. Families who identify 
with the families in the video can self-refer for a program screener with our team. Teachers or school clinicians 
also may refer families for a program screener with our team. We have used this recruitment strategy 
successfully in the CLS-FUERTE program pilot. To qualify, youth must demonstrate >6 symptoms of 
inattention and/or >6 symptoms of hyperactivity/ impulsivity rated by parents or teachers, and >1 domain of 
impaired functioning, on a screening with our study team). In addition, > 1 parent or caregiver (here-on referred 
to as “parent”) and > 1 teacher of the youth must speak Spanish and be willing/available to participate in 
sessions.   
 
EXCLUSION CRITERIA: Anyone who does not speak and read Spanish will be excluded, given that all 
informed consent, measurement, and activity procedures will be conducted in Spanish.   
 
Child Participants  
-Children taking medication will be eligible for screening after the child has been on a stable medication 
regimen for at least one month (to minimize chance that treatment effects are due to medication and not the 
proposed program).  
-Presence of conditions that are incompatible with this study’s treatment.  
-severe visual or hearing impairment,  
-severe language delay,  
-psychosis,  
-Child is in an all-day special education classroom.  
 
-Children in these classrooms are frequently receiving intensive behavior modification programs and 
assistance such that the teacher consultation component would be expected to require modification for use in 
these settings.  
 
CHILD PARTICIPANT ELIGIBILITY: Screening and confirmation of eligibility for youth will follow a three-stage 
(multiple-gated) procedure.  

 
Stage 1) Involves identification of children by parent self-referral or staff clinicians at each participating school; 
children must be having academic and social problems related to inattention and/or hyperactivity/impulsivity. 
Students who meet first stage entry criteria (e.g., age, grade, mainstream class placement, absence of 
significant visual or hearing impairment, severe language delay, psychosis, global intellectual impairment, or 
serious emotional disturbance requiring special education services, per school clinicians and school records, 
and living with a caretaker who is available to participate in treatment) will be invited to participate in screening.  
 
Stage 2) Next, our program staff will initiate contact with families who self-referred or are referred by the school 
or referred families can contact our program staff themselves. Families will complete a screening (remote or in-
person, depending on their preference) with our program staff about academic, social, and behavioral 
functioning at school and at home. Questions from the Developmental Family History Form and items from the 
Child Symptom Inventory-CSI are used to determine sufficient impairment. Parents of children who meet these 
criteria will be invited to the third stage of screening.  
 
Stage 3) During the final stage, parents complete the CSI, IRS, and Developmental History Form. Teachers 
also complete the CSI and IRS. After parents and teachers complete rating forms, judgements about eligibility 
at stage 3 will be made by UCSF program staff based on the interview and ratings provided by teachers and 
parents. To document ADHD symptom presence, we require six or more inattention symptoms and/or six or 
more hyperactive-impulsive symptoms endorsed by either the parent or teacher as occurring ‘often’ or ‘very 
often’. To document cross-situational impairment (and need for home and school treatment), we require 
impairment in at least one domain on the Impairment Rating Scale by both parent and teacher (score of 3 or 
greater). Committee on Human Research (CHR) approved study descriptions are reviewed and families 
complete consent and assent forms. Those who consent will complete remaining baseline measures. we will 
then review all available data, including symptom counts and impairment, following DSM-V guidelines. Final 
determination of eligibility will be based on the child meeting all study criteria as determined by the PI. Parent 
Participant Eligibility: Must have a child whom meets the above eligibility requirements. The parent must 
participate in the intervention. Teacher Participant Eligibility: Must have a student whom is participating in the 
program. The teacher must be willing to participate in the intervention. We have used these eligibility criteria 
successfully in the CLS-FUERTE program pilot.  
 
CONSENT AND ASSENT PROCESS School clinicians are informed about the study through the school district 
SEP liaison. When school clinicians express interest, school site meetings are conducted with the school 
principal, school clinician and other school staff (if requested) to describe the project and obtain principal 
approval for participation. If approval is obtained, consent forms will be administered to the school clinicians by 
our staff. School clinicians approach referred families to explain the project. At this time, students who meet 
first stage entry criteria will be invited to participate in the screening process to determine eligibility and will 
provide verbal consent for exchange of information between the school and our program staff. Families will 
have the option to complete the consent process over the phone or Zoom video conferencing (using Docusign 
to electronically sign the form), at the child’s school, or at UAS. Our staff will explain the study and review the 
consent/assent forms with the family, ensure that the family understands the major points of informed consent, 
and address any questions. Families will be given as much time as they need to consider participation, and if 
they prefer to reschedule their appointment to allow for more time to consider, that will be arranged. If more 
than one parent/guardian has legal custody, reasonable effort will be made to contact the second 
parent/guardian and gain consent (and such efforts will be documented on the consent form). Minors will 
complete a simplified assent form. If, after carefully reviewing the study requirements including risks and 
benefits, the parent wishes to participate but the child does not, the family will not be eligible. Parents will be 
referred back to the school for assistance with alternative services, if desired. Once the family has consented 
our staff will obtain written consent from teachers at their school site or electronically using Docusign. Teachers 
will have the option to complete the consent process in-person, over the phone or Zoom video conferencing 
(using Docusign to electronically sign the form), at their school, or at UAS.  
 
ESTIMATED TIME COMMITMENT FOR PARTICIPANTS: Youth: 6 60-minute sessions and 1-2 30-minute 
meetings (Total up to 7 hours) Teachers: 1 1-hour session, 1-2 30-minute meetings, and up to 2-hours to fill 
out measures (Total up to 4 hours) Parents: 6 90-minute sessions, 1-2 30-minute meetings, and up to 2-hours 
to fill out measures (Total up to 12 hours) School clinicians: 6 60-minute child sessions, 6 90-minute parent 

sessions, 1 1-hour teacher sessions, up to 16 30-minute meetings, 9 hours of consultation, and up to 2-hours 
to fill out measures (Total up to 35 hours)  
 
STATISTICAL METHODS: We will test the CLS-R-FUERTE program compared to services-as-usual (SAU) in 
an 8-school clustered RCT by examining if improvements on youth outcomes differ between groups. We will 
use the SPSS GENLIN procedure to model generalized estimating equations (GEE) using an independent 
correlation matrix comparing outcomes of CLS-R-FUERTE to SAU while controlling for school clustering. 
Models will include main effects for baseline ratings and treatment group as well as the interaction effect. The 
Benjamini–Hochberg correction procedure will be used to evaluate significance of the models while controlling 
for family-wise Type 1 errors. Finally, Hedges’ g effect sizes characterizing the between groups effect will be 
examined. Hedge’s g is appropriate for small sample sizes; estimates are interpreted consistent with 
Cohen’s d effect sizes (i.e., 0.2 = small, 0.5 = moderate, 0.8 = large).