Adapting a Web-Based Professional Development for Mexican School Mental Health Providers Delivering Evidence-Based Intervention for ADHD and ODD

• ClinicalTrials.gov Identifier: NCT05425966
• Recruitment Status: Recruiting
• First Posted: June 21, 2022
• Last Update Posted: June 21, 2022
• Sponsor: University of California, San Francisco
• Collaborator: National Institute of Mental Health (NIMH)
• Information provided by (Responsible Party): University of California, San Francisco

Study Description

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-homeADHD/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 conducting an open-trial of the fully-remote program and make iterative changes. It is predicted that: H1) school clinicians trained remotely will be satisfied and show improved evidence-based practice skills; H2)families and teachers participating remotely will be satisfied and youth will show improved ADHD/ODD; H3) observation/feedback from a 3-school open-trial will guide iterative changes to the remote program.

Condition or disease	Intervention/treatment	Phase
ADHD; Oppositional Defiant Disorder	Behavioral: CLS-R-FUERTE	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 69 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Adapting a Remote Training for Mexican School Clinicians Delivering Evidence-Based Intervention for ADHD and ODD
• Actual Study Start Date: September 1, 2021
• Estimated Primary Completion Date: June 30, 2023
• Estimated Study Completion Date: June 30, 2023

Arms and Interventions

Arm

Intervention/treatment

Experimental: CLS-R-FUERTE; Active program participation in: a remote school clinician training and comprehensive psychosocial intervention designed to improve attention and behavior in Mexican school-aged youth (grades 1-5). via school clinician training by a clinical research team to lead parent skill groups, child skill groups, and teacher consultation in a behavioral classroom management system.

Behavioral: CLS-R-FUERTE; The CLS-R-FUERTE program is a remote school clinician training and comprehensive psychosocial intervention designed to improve attention and behavior in Mexican school-aged youth (grades 1-5). It contains the same evidence-based service components to improve youth attention/behavior as the in-person CLS-FUERTE program; specifically, it features school clinician training by a clinical research team to lead parent skill groups, child skill groups, and teacher consultation in a behavioral classroom management system.

Outcome Measures

Primary Outcome Measures :

1. Change in Child Symptom Inventory-4 (CSI-4) Parent Checklist ADHD Combined type Symptom Severity Score [ Time Frame: Baseline and post treatment (8 weeks) ]
   Parents will assess ADHD symptoms using the CSI-4. The CSI-4: Parent Checklist contains 18 symptoms for ADHD, Combined type (ADHD:C; 18 items). Each symptom is rated on a 4-point scale (0= never to 3= very often). The average of ADHD:C scores range from zero to four, with higher scores indicating more severe symptoms.
2. Change in Child Symptom Inventory-4 (CSI-4) Teacher Checklist ADHD Combined type Symptom Severity Score [ Time Frame: Baseline and post treatment (8 weeks) ]
   Teachers will assess ADHD symptoms using the CSI-4. The CSI-4: Teacher Checklist contains 18 symptoms for ADHD, Combined type (ADHD:C; 18 items). Each symptom is rated on a 4-point scale (0= never to 3= very often). The average of ADHD:C scores range from zero to four, with higher scores indicating more severe symptoms.
3. Change in Child Symptom Inventory-4 (CSI-4) Parent Checklist (Oppositional Defiant Disorder) ODD Symptom Severity Score [ Time Frame: Baseline and post treatment (8 weeks) ]
   Parents will assess ODD symptoms using the CSI-4. The CSI-4: Parent Checklist contains 9 symptoms of ODD. Each symptom is rated on a 4-point scale (0= never to 3= very often). The average ODD scores range from zero to four, with higher scores indicating more severe symptoms.
4. Change in Child Symptom Inventory-4 (CSI-4) Teacher Checklist (Oppositional Defiant Disorder) ODD Symptom Severity Score [ Time Frame: Baseline and post treatment (8 weeks) ]
   Teachers will assess ODD symptoms using the CSI-4. The CSI-4: Teacher Checklist contains 9 symptoms of ODD. Each symptom is rated on a 4-point scale (0= never to 3= very often). The average ODD scores range from zero to four, with higher scores indicating more severe symptoms.
5. Change Impairment Rating Scale (IRS) Parent Questionnaire Overall Severity Score [ Time Frame: Baseline and post treatment (8 weeks) ]
   Parents will assess impairment using the IRS. The IRS Teacher Questionnaire contains 8 items of functional impairment (i.e., academic and peer relations). Each item is rated on a 7-point scale (1= no problem; does not need treatment/services to 7= extreme impairment; definitely needs treatment/services). The average of all IRS scores range from one to seven, with higher scores indicating more severe impairment.
6. Change Impairment Rating Scale (IRS) Teacher Questionnaire Overall Severity Score [ Time Frame: Baseline and post treatment (8 weeks) ]
   Teachers will assess impairment using the IRS. The IRS Teacher Questionnaire contains 8 items of functional impairment (i.e., academic and peer relations). Each item is rated on a 7-point scale (1= no problem; does not need treatment/services to 7= extreme impairment; definitely needs treatment/services). The average of all IRS scores range from one to seven, with higher scores indicating more severe impairment.

Eligibility Criteria

• Ages Eligible for Study: 5 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Contacts

Contact: Lauren M Haack, PhD; 415-502-8060; lauren.haack@ucsf.edu

Locations

United States, California

UCSF; Recruiting

San Francisco, California, United States, 94104

Contact: Lauren Haack, PhD 415-502-8060 lauren.haack@ucsf.edu

Sponsors and Collaborators

University of California, San Francisco

National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: Lauren M Haack, PhD; University of California, San Francisco

More Information

• Responsible Party: University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT05425966
• Other Study ID Numbers: CLSRFUERTE; R21MH124066 ( U.S. NIH Grant/Contract )
• First Posted: June 21, 2022
• Last Update Posted: June 21, 2022
• Last Verified: June 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

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