Web-based Professional Development for SMHPs in Evidence-Based Practices for Attention and Behavior Challenges

ADHD Clinical Trial

— CLS-R  

Official title:

Web-based Professional Development for School Mental Health Providers in Evidence-Based Practices for Attention and Behavior Challenges

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05713331
• Other study ID #: R305A170338
• Status: Terminated
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: June 30, 2020

Study information

• Verified date: January 2023
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

1. Title of Project: Web-Based Professional Development for School Mental Health Providers in Evidence-Based Practices for Attention and Behavior Challenges 2. RFA Topic and Goal: Social and Behavioral Context for Academic Learning, Goal 2 3. 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. 4. Setting: The research will be conducted in elementary schools within San Francisco Unified School District (SFUSD). 5. Sample: Participants will include SFUSD school social workers (SSWs), students, parents and teachers. 6. 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. 7. Control Condition: N/A 8. 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. 9. Key measures: Measures of process (training fidelity, attendance), feasibility, usability, and acceptability will be obtained. 10. 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 79
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• ADHD

Intervention

Behavioral:
• CLS-R
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.

Locations

Country	Name	City	State
United States	HALP Clinic, Children's Center at Langley Porter, UCSF	San Francisco	California
United States	University of California San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Institute of Education Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptoms of Attention Deficit Hyperactivity Disorder as defined by DSMV	Parent and teacher rating scale	Change from baseline to post-treatment
Secondary	Homework Problems Checklist (HPC)	Parent-rated scale	Change from baseline to post-treatment
Secondary	Children's Organizational Skills Scale (COSS)	Parent and teacher rating scale	Change from baseline to post-treatment
Secondary	Symptoms of Oppositional Defiant Disorder as defined by DSMV	Parent and teacher rating scale	Change from baseline to post-treatment
Secondary	Strengths and Difficulties Questionnaire	Parent and teacher rating scale	Change from baseline to post-treatment
Secondary	Clinical Global Improvement	Parent and teacher rating scale	Change from baseline to post-treatment
Secondary	School Mental Health Provider Rating of Skill Competence, Motivation and Knowledge	School mental health provider rating scale	Change from baseline to post-treatment
Secondary	Alabama Parenting Questionnaire	Parent rating scale	Change from baseline to post-treatment
Secondary	Parenting Stress Index	Parent rating scale	Change from baseline to post-treatment