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

Sponsor
University of California, San Francisco (Other)
Overall Status
Terminated
CT.gov ID
NCT05713331
Collaborator
Institute of Education Sciences (U.S. Fed)
79
2
2
33.9
39.5
1.2

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: CLS-R
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
79 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Web-based Professional Development for School Mental Health Providers in Evidence-Based Practices for Attention and Behavior Challenges
Actual Study Start Date :
Sep 1, 2017
Actual Primary Completion Date :
Jun 30, 2020
Actual Study Completion Date :
Jun 30, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: CLS-R

Web-based remote training for school mental health providers

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.

Active Comparator: CLS

In-person training for school mental health providers

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.

Outcome Measures

Primary Outcome Measures

  1. Symptoms of Attention Deficit Hyperactivity Disorder as defined by DSMV [Change from baseline to post-treatment]

    Parent and teacher rating scale

Secondary Outcome Measures

  1. Homework Problems Checklist (HPC) [Change from baseline to post-treatment]

    Parent-rated scale

  2. Children's Organizational Skills Scale (COSS) [Change from baseline to post-treatment]

    Parent and teacher rating scale

  3. Symptoms of Oppositional Defiant Disorder as defined by DSMV [Change from baseline to post-treatment]

    Parent and teacher rating scale

  4. Strengths and Difficulties Questionnaire [Change from baseline to post-treatment]

    Parent and teacher rating scale

  5. Clinical Global Improvement [Change from baseline to post-treatment]

    Parent and teacher rating scale

  6. School Mental Health Provider Rating of Skill Competence, Motivation and Knowledge [Change from baseline to post-treatment]

    School mental health provider rating scale

  7. Alabama Parenting Questionnaire [Change from baseline to post-treatment]

    Parent rating scale

  8. Parenting Stress Index [Change from baseline to post-treatment]

    Parent rating scale

Eligibility Criteria

Criteria

Ages Eligible for Study:
7 Years to 11 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 HALP Clinic, Children's Center at Langley Porter, UCSF San Francisco California United States 94143
2 University of California San Francisco San Francisco California United States 94143

Sponsors and Collaborators

  • University of California, San Francisco
  • Institute of Education Sciences

Investigators

  • Principal Investigator: Linda Pfiffner, PhD, University of California, San Francisco

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT05713331
Other Study ID Numbers:
  • R305A170338
First Posted:
Feb 6, 2023
Last Update Posted:
Feb 6, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Feb 6, 2023