- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05713331
Web-based Professional Development for SMHPs in Evidence-Based Practices for Attention and Behavior Challenges (CLS-R)
January 26, 2023 updated by: University of California, San Francisco
Web-based Professional Development for School Mental Health Providers in Evidence-Based Practices for Attention and Behavior Challenges
This study develops a web-based PD (CLS-R) to provide SSWs with remote training in EBPs for attention and behavior problems.
CLS-R is designed to be usable, feasible, portable, accessible, and acceptable - ingredients which have been identified as necessary for the sustainability of school-based programs.
The study evaluates the usability, feasibility, acceptability, fidelity of implementation, and preliminary effects on student outcomes.
Study Overview
Detailed Description
- Title of Project: Web-Based Professional Development for School Mental Health Providers in Evidence-Based Practices for Attention and Behavior Challenges
- RFA Topic and Goal: Social and Behavioral Context for Academic Learning, Goal 2
- Purpose: Development of a web-based professional development program (PD) for school mental health providers to gain the skills needed to implement evidence-based practices (EBPs) for attention and behavior problems.
- Setting: The research will be conducted in elementary schools within San Francisco Unified School District (SFUSD).
- Sample: Participants will include SFUSD school social workers (SSWs), students, parents and teachers.
- Professional Development to be developed: The Collaborative Life Skills (CLS) program will be developed into a web-based format (CLS-R) with all training and consultation provided remotely via videoconferencing. Includes EBP skill modules for consulting with teachers and parents and working with students directly.
- Control Condition: N/A
- Research design and methods: (1)Open Trials and Refinement: CLS-R will be field tested with 4 SSWs delivering the intervention to students, parents, and teachers. Modification and refinement of materials, manuals, and procedures will follow each trial based on questionnaire data and focus groups. Outcomes will evaluate usability, feasability, and acceptability, implementation fidelity, preliminary effects on student outcomes, and post-training sustainability of SSW EBP skill use. (2) Pilot Study: Using a randomized design, we will compare CLS-R and CLS. Six SSWs will receive CLS-R and 6 SSWs will receive CLS. To temporarily conduct study during COVID-19 school closures, we will test feasbility, usability and accesptability of the fully remote CLS parent component.
- Key measures: Measures of process (training fidelity, attendance), feasibility, usability, and acceptability will be obtained.
- Data analytic strategy: CLS-R usability and feasibility will focus on qualitative analysis of themes from focus groups, quantitative analyses of rating scales, and descriptive analyses of functionality.
Study Type
Interventional
Enrollment (Actual)
79
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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San Francisco, California, United States, 94143
- University of California San Francisco
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San Francisco, California, United States, 94143
- HALP Clinic, Children's Center at Langley Porter, UCSF
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 years to 11 years (CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Children ages 7-11, 2nd-5th grades
- Presence of academic and social problems related to inattention and/or hyperactivity/impulsivity (as judged by school SSW)
- Six or more inattention symptoms and/or six or more hyperactive/impulsive symptoms endorsed across parent and teacher rating scales (using an either-or algorithm, such that a symptom is counted as being present if either parent or teacher endorses it as occurring 'often' or 'very often')
- Functional impairment reported by either parent or teacher on the IRS (score of 3 or greater)
- Caretaker available and consents to participate in treatment
- Currently attending a participating school full-time
Exclusion Criteria:
Presence of conditions that are incompatible with this study's treatment:
- severe visual or hearing impairment,
- severe language delay,
- psychosis,
- pervasive developmental disorder
- Parent or child does not read or speak English or does not read or speak Spanish for our Spanish language implementation of CLS (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 such that the intervention would be expected to require modification for use in these settings)
- Children taking psychotropic medication for any reason other than to treat ADHD
- Children planning to change (start or stop) psychotropic medication
- Children who have changed a regimen of psychotropic medication (started or stopped) within 30 days prior to screening
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: CLS-R
Web-based remote training for school mental health providers
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CLS-R Training includes school provider training in CLS via web platform and videoconferencing for workshops, consultation and coaching.CLS is a 10-12 week program and includes school, parent, and student components which are integrated via joint teacher, parent, and student meetings and use of integrated behavioral programs in the classroom and home.
|
ACTIVE_COMPARATOR: CLS
In-person training for school mental health providers
|
CLS-R Training includes school provider training in CLS via web platform and videoconferencing for workshops, consultation and coaching.CLS is a 10-12 week program and includes school, parent, and student components which are integrated via joint teacher, parent, and student meetings and use of integrated behavioral programs in the classroom and home.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Symptoms of Attention Deficit Hyperactivity Disorder as defined by DSMV
Time Frame: Change from baseline to post-treatment
|
Parent and teacher rating scale
|
Change from baseline to post-treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Homework Problems Checklist (HPC)
Time Frame: Change from baseline to post-treatment
|
Parent-rated scale
|
Change from baseline to post-treatment
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Children's Organizational Skills Scale (COSS)
Time Frame: Change from baseline to post-treatment
|
Parent and teacher rating scale
|
Change from baseline to post-treatment
|
Symptoms of Oppositional Defiant Disorder as defined by DSMV
Time Frame: Change from baseline to post-treatment
|
Parent and teacher rating scale
|
Change from baseline to post-treatment
|
Strengths and Difficulties Questionnaire
Time Frame: Change from baseline to post-treatment
|
Parent and teacher rating scale
|
Change from baseline to post-treatment
|
Clinical Global Improvement
Time Frame: Change from baseline to post-treatment
|
Parent and teacher rating scale
|
Change from baseline to post-treatment
|
School Mental Health Provider Rating of Skill Competence, Motivation and Knowledge
Time Frame: Change from baseline to post-treatment
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School mental health provider rating scale
|
Change from baseline to post-treatment
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Alabama Parenting Questionnaire
Time Frame: Change from baseline to post-treatment
|
Parent rating scale
|
Change from baseline to post-treatment
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Parenting Stress Index
Time Frame: Change from baseline to post-treatment
|
Parent rating scale
|
Change from baseline to post-treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 1, 2017
Primary Completion (ACTUAL)
June 30, 2020
Study Completion (ACTUAL)
June 30, 2020
Study Registration Dates
First Submitted
October 31, 2022
First Submitted That Met QC Criteria
January 26, 2023
First Posted (ACTUAL)
February 6, 2023
Study Record Updates
Last Update Posted (ACTUAL)
February 6, 2023
Last Update Submitted That Met QC Criteria
January 26, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- R305A170338
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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