Clinical trial NCT05713331: Web-based Professional Development for SMHPs in Evidence-Based Practices for Attention and Behavior Challenges
Official title: Web-based Professional Development for School Mental Health Providers in Evidence-Based Practices for Attention and Behavior Challenges
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: ADHD
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Institute of Education Sciences
First posted: 2023-02-06
Enrollment: 79
Sex: ALL
Minimum age (years): 7
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Symptoms of Attention Deficit Hyperactivity Disorder as defined by DSMV
timeFrame: Change from baseline to post-treatment
Secondary outcomes:
measure: Homework Problems Checklist (HPC)
timeFrame: Change from baseline to post-treatment
measure: Children's Organizational Skills Scale (COSS)
timeFrame: Change from baseline to post-treatment
measure: Symptoms of Oppositional Defiant Disorder as defined by DSMV
timeFrame: Change from baseline to post-treatment
measure: Strengths and Difficulties Questionnaire
timeFrame: Change from baseline to post-treatment
measure: Clinical Global Improvement
timeFrame: Change from baseline to post-treatment
measure: School Mental Health Provider Rating of Skill Competence, Motivation and Knowledge
timeFrame: Change from baseline to post-treatment
measure: Alabama Parenting Questionnaire
timeFrame: Change from baseline to post-treatment
measure: Parenting Stress Index
timeFrame: Change from baseline to post-treatment
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: HALP Clinic, Children's Center at Langley Porter, UCSF
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Linda Pfiffner, PhD
role: PRINCIPAL_INVESTIGATOR
References: