Clinical trial NCT05496140: Remote School-Home Program to Improve Youth Attention and Behavior in Mexican Students
Official title: Remote School-Home Program to Improve Youth Attention and Behavior in Mexican Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ADHD
Oppositional Defiant Disorder
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2022-08-11
Enrollment: 163
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 8-school clustered randomized controlled trial (RCT).
Primary purpose: TREATMENT

Brief summary: Neurodevelopmental disorders of inattention and disruptive behavior, such as Attention-Deficit/ Hyperactivity Disorder (ADHD) and Oppositional Defiant Disorder (ODD), are among the most common youth mental health conditions across cultures. An efficacious and feasible solution to improving affected youth's ADHD/ODD is training existing school clinicians to deliver evidence-based intervention with fidelity. Despite initial promising results of training school clinicians to treat ADHD/ODD in settings suffering from high unmet need, such as Mexico, scalability is limited by a lack of researchers with capacity to train, monitor, and evaluate school clinicians in such efforts on a large scale. Thus, there is a need to develop more feasible interventions and training programs for school clinicians, as well as create a system with capacity for scalable training and evaluation, to combat the widespread impact ofADHD/ODD worldwide. Converting interventions and school clinician professional development programs for fully-remote delivery allows for more flexibility, accessibility, affordability, scalability, and promise for ongoing consultation than in-person options. Supporting scalable training for school clinicians could address a significant public health concern in Mexico, as only 14% of Mexican youth with mental health disorders receive treatment and less than half of those treated receive more than minimally adequate care. The study team is uniquely suited for this effort, given that they developed the only known school-home ADHD/ODD evidence-based intervention in Latin America-and-have developed a web-based training for U.S. school clinicians with promising preliminary results. The study team's prior studies and high levels of unmet need make Mexico an ideal location for this proposal; however, lessons learned could be used to expand scalable school clinician training for evidence-based intervention in other settings and/or for other disorders. Thus, this study focuses on comparing the fully-remote CLS-R-FUERTE program vs. care-as-usual in an 8-school clustered randomized controlled trial (RCT). The team predicts: 1) school clinicians trained in the remote program will be satisfied and show improved skills, 2) parents, youth, and teachers treated by school clinicians in the remote program will engage/adhere, and 3) youth in the remote program will show more ADHD/ODD improvements compared to care-as-usual


Eligibility criteria: Inclusion Criteria:

* Students meeting the following criteria are eligible:

  * at least six inattention symptoms and/or six hyperactive/impulsive symptoms endorsed by parent or teacher as occurring often or very often,
  * at least one area of impairment rated as concerning by both parent and teacher, and
  * a parent and teacher agreeing to participate.
  * Students taking medication are eligible as long as regimens were stable.
* Parents and teachers and school clinicians of participating are eligible to participate.

Exclusion Criteria:

All Participants: 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 does not read or speak Spanish (inability to complete assessment measures or participate in group treatments).
* 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.

Primary outcomes:
measure: Change in Child Symptom Inventory-4 (CSI-4) Parent Checklist ADHD Combined Type Symptom Severity Score
timeFrame: Baseline and post treatment (8 weeks)
measure: Change in Child Symptom Inventory-4 (CSI-4) Teacher Checklist ADHD Combined Type Symptom Severity Score
timeFrame: Baseline and post treatment (8 weeks)
measure: Change in Child Symptom Inventory-4 (CSI-4) Parent Checklist (Oppositional Defiant Disorder) ODD Symptom Severity Score
timeFrame: Baseline and post treatment (8 weeks)
measure: Change in Child Symptom Inventory-4 (CSI-4) Teacher Checklist (Oppositional Defiant Disorder) ODD Symptom Severity Score
timeFrame: Baseline and post treatment (8 weeks)
measure: Change Impairment Rating Scale (IRS) Parent Questionnaire Overall Severity Score
timeFrame: Baseline and post treatment (8 weeks)
measure: Change Impairment Rating Scale (IRS) Teacher Questionnaire Overall Severity Score
timeFrame: Baseline and post treatment (8 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF
state: California
Study officials:
affiliation: University of California, San Francisco
name: Lauren M Haack, PhD
role: PRINCIPAL_INVESTIGATOR
References: