BASIS-T Efficacy Trial

NCT05989568 | Recruiting

• 1 other identifier: STUDY00017371
• Study Type: interventional
• Target: 276
• Locations: 1 country
• Sites: 1

Brief Summary

For the approximately one in five children with social, emotional, and behavioral (SEB) challenges, accessible evidence-based prevention practices (EBPPs) are critical. In the United States, schools are the primary service setting for children's SEB service delivery but EBPPs are rarely adopted or implemented by educators (e.g., teachers) with sufficient fidelity to see effects. Given that individual behavior change is ultimately required for successful implementation, focusing on individual-level processes holds promise as a parsimonious approach to enhance adoption. Beliefs and Attitudes for Successful Implementation in Schools for Teachers (BASIS-T) is a pragmatic, multifaceted pre-implementation strategy targeting volitional and motivational mechanisms of educators' behavior change to enhance implementation and student SEB outcomes. This study protocol describes a hybrid type 3 effectiveness-implementation trial designed to evaluate the main effects, mediators, and moderators of the BASIS-T implementation strategy in the context of Positive Greetings at the Door (PGD), a universal school-based EBPP previously demonstrated to reduce student disruptive behavior and increase academic engagement.

Conditions

Behavior, Child

Outcome Measures

Primary Outcomes (8)

• Proximal Outcome: Attitudes

  Evidence-Based Attitudes Scale - a 15-item tool that captures attitudes toward evidence-based practices. The scale includes internally consistent scores including total score and subscale scores: (1) appeal of EBP, (2) openness to new practices, (3) likelihood of adopting an evidence-based practice, and (4) perceived divergence between current and evidence-based practices. Minimum Score 0, Maximum Score 4. Higher Scores mean better outcome.

  Baseline, 2-weeks, 4-weeks, 2-months, 3-months, 4-months, 5-months, 6-months, 9-months, 15-months

• Proximal Outcome: Subjective Norms

  Subjective Norms about EBPP Implementation will be measured via 6-item self-report measure developed based on established guidelines to capture injunctive and descriptive norms regarding specific behaviors. Minimum Score 0, Maximum Score 800. Higher Scores mean better outcome.

  Baseline, 2-weeks, 4-weeks, 2-months, 3-months, 4-months, 5-months, 6-months, 9-months, 15-months

• Proximal Outcome: Self-Efficacy

  Modified Teacher Self-Efficacy Scale. A modified version of the Teacher Self-Efficacy Scale will be used to assess educators' self-efficacy belief. This scale includes 10-items that assess teachers' confidence and self-efficacy regarding teaching practices. This measure will also be used to assess maintenance self-efficacy after teachers initiate implementation of PGD. Minimum Score 0, Maximum Score 4. Higher Scores mean better outcome.

  Baseline, 2-weeks, 4-weeks, 2-months, 3-months, 4-months, 5-months, 6-months, 9-months, 15-months

• Proximal Outcome: Intentions to Implement

  Modified-Intentions to Use Scale (Intentions). The Modified-Intentions to Use Scale is based on work investigating practitioners' intention to adhere to measurement-based care. The survey includes 5-items modified to be consistent with educators' intentions to use SEB EBPs. This survey is qualitative, and therefore does not have numerical scoring.

  Baseline, 2-weeks, 4-weeks, 2-months, 3-months, 4-months, 5-months, 6-months, 9-months, 15-months

• Implementation Outcome: Adoption

  Adoption data will be gathered via monthly self-report checklist of fidelity. Minimum Score 0, Maximum Score 15. Higher Scores mean better outcome.

  2-weeks, 4-weeks, 2-months, 3-months, 4-months, 5-months, 6-months, 9-months, 15-months

• Implementation Outcome: Fidelity and Sustainment - Observed

  School administrative staff will be trained to conduct PGD fidelity observations and complete a PGD observation form 3 times per teacher over the course of the school year. Minimum Score 0, Maximum Score 6. Higher Scores mean better outcome.

  Beginning of School Year, Mid-School Year, End of School Year

• Implementation Outcome: Fidelity and Sustainment - Self Report

  A self-report checklist will be used to capture adherence to delivering core PGD practices as planned. Teachers will complete the checklist monthly both years. Minimum Score 0, Maximum Score 15. Higher Scores mean better outcome.

  Baseline, 2-weeks, 4-weeks, 2-months, 3-months, 4-months, 5-months, 6-months, 9-months, 15-months

• Implementation Outcome: Reach

  Reach will be computed using the fidelity data to determine the proportion of students who are receiving PGD practices. Specifically, teachers who are delivering PGD practices with 75% or greater fidelity will be classified as classrooms where students are receiving PGD. The number of students in these classrooms will be divided by the total students across classrooms of teachers who have received PGD training.

  Baseline, 2-weeks, 4-weeks, 2-months, 3-months, 4-months, 5-months, 6-months, 9-months, 15-months

Secondary Outcomes (2)

• Student Educational Outcomes

  9-months

• Student Behavioral Outcomes

  Baseline, 2-weeks, 4-weeks, 2-months, 3-months, 4-months, 5-months, 6-months, 9-months, 15-months

Study Arms (2)

BASIS-T

EXPERIMENTAL

BASIS-T is designed to address the behavioral components often missing from standard EBPP training and consultation that relate to motivation prior to receiving EBPP training, and volition after EBPP training. It is an EBPP-agnostic implementation strategy designed to be delivered within the Preparation/Adoption phase, immediately prior to Active Implementation (CITE EPIS). BASIS-T targets behavioral intentions via improvement in attitudes, subjective norms, and self-efficacy.

Behavioral: BASIS-T

Attention Control

PLACEBO COMPARATOR

Teachers assigned to the ACC will receive pre- and post-training experiences designed to mirror those received in the BASIS-T condition. These training experiences will be virtual, delivered by the same interventionist, and be approximately the same length as the BASIS-T experiences, but will not contain any of the BASIS-T content or mechanisms of change. The ACC pre-training experience will define, describe, and advocate for EBP implementation in schools. Content will be didactic, as is typical in professional development training for teachers.

Behavioral: Attention Control (ACC)

Interventions

BASIS-T BEHAVIORAL

BASIS-T is designed to address the behavioral components often missing from standard EBPP training and consultation that relate to motivation prior to receiving EBPP training, and volition after EBPP training. It is an EBPP-agnostic implementation strategy designed to be delivered within the Preparation/Adoption phase, immediately prior to Active Implementation (CITE EPIS). BASIS-T targets behavioral intentions via improvement in attitudes, subjective norms, and self-efficacy.

BASIS-T

Attention Control (ACC) BEHAVIORAL

Teachers assigned to the ACC will receive pre- and post-training experiences designed to mirror those received in the BASIS-T condition. These training experiences will be virtual, delivered by the same interventionist, and be approximately the same length as the BASIS-T experiences, but will not contain any of the BASIS-T content or mechanisms of change. The ACC pre-training experience will define, describe, and advocate for EBP implementation in schools. Content will be didactic, as is typical in professional development training for teachers.

Attention Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being a K-5th grade teacher at an elementary or K-8 school, and not a teacher in a special education-only classroom

You may not qualify if:

• Having been trained or supervised on delivering PGD in the past 5 years

Sponsors & Collaborators

• University of Washington: lead
• Institute of Education Sciences: collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98115, United States

RECRUITING

Related Publications (1)

• Lyon AR, Cook CR, Larson M, Hugh ML, Dopp A, Hamlin C, Reinke P, Bose M, Law A, Goosey R, Goerdt A, Morrell N, Wackerle-Hollman A, Pullmann MD. Protocol for a hybrid type 3 effectiveness-implementation trial of a pragmatic individual-level implementation strategy for supporting school-based prevention programming. Implement Sci. 2024 Jan 2;19(1):2. doi: 10.1186/s13012-023-01330-y.

  PMID: 38167046 DERIVED

MeSH Terms

Conditions

Child Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Aaron Lyon, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aaron Lyon, PhD

CONTACT

206-221-8604; lyona@uw.edu

Mike Pullmann, PhD

CONTACT

pullmann@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor: School of Medicine

Study Record Dates

• First Submitted: May 30, 2023
• First Posted: August 14, 2023
• Study Start: August 8, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: December 4, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data requests can be submitted to the PI starting 6 months after initial publication of the primary findings. The PI will continue to accept requests for those findings for 24 months following the end-date of the awarded grant.
• Access Criteria: Access to study data can be requested by any qualified researchers who are engaging in independent scientific research, with approval dictated by the PI. Acceptance of data sharing will only be done following review of a sharing agreement.

Locations

US (1)