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

NCT05713331 | Terminated

• 1 other identifier: R305A170338
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 2

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.

Conditions

ADHD

Outcome Measures

Primary Outcomes (1)

• Symptoms of Attention Deficit Hyperactivity Disorder as defined by DSMV

  Parent and teacher rating scale

  Change from baseline to post-treatment

Secondary Outcomes (8)

• Homework Problems Checklist (HPC)

  Change from baseline to post-treatment

• Children's Organizational Skills Scale (COSS)

  Change from baseline to post-treatment

• Symptoms of Oppositional Defiant Disorder as defined by DSMV

  Change from baseline to post-treatment

• Strengths and Difficulties Questionnaire

  Change from baseline to post-treatment

• Clinical Global Improvement

  Change from baseline to post-treatment

Study Arms (2)

CLS-R

EXPERIMENTAL

Web-based remote training for school mental health providers

Behavioral: CLS-R

CLS

ACTIVE COMPARATOR

In-person training for school mental health providers

Behavioral: CLS-R

Interventions

CLS-R BEHAVIORAL

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.

CLS; CLS-R

Eligibility Criteria

• Age: 7 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Institute of Education Sciences: collaborator

Study Sites (2)

HALP Clinic, Children's Center at Langley Porter, UCSF

San Francisco, California, 94143, United States

Location

University of California San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

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

Study Officials

• Linda Pfiffner, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2022
• First Posted: February 6, 2023
• Study Start: September 1, 2017
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: February 6, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)