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Recruiting NCT05989568

BASIS-T Efficacy Trial

No phase Interventional Behavior, Child

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BASIS-T, Attention Control (ACC).
Who it may be relevant to
Registry conditions: Behavior, Child. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Supporting Teachers in Implementing Classroom Practices to Build Better Student-Teacher Relationships

Overview

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.

Interventions

  • Behavioral BASIS-T
    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 Attention Control (ACC)
    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

Primary outcome measures

  • Proximal Outcome: Attitudes [Time frame: Baseline, 2-weeks, 4-weeks, 2-months, 3-months, 4-months, 5-months, 6-months, 9-months, 15-months]
  • Proximal Outcome: Subjective Norms [Time frame: Baseline, 2-weeks, 4-weeks, 2-months, 3-months, 4-months, 5-months, 6-months, 9-months, 15-months]
  • Proximal Outcome: Self-Efficacy [Time frame: Baseline, 2-weeks, 4-weeks, 2-months, 3-months, 4-months, 5-months, 6-months, 9-months, 15-months]
  • Proximal Outcome: Intentions to Implement [Time frame: Baseline, 2-weeks, 4-weeks, 2-months, 3-months, 4-months, 5-months, 6-months, 9-months, 15-months]
  • Implementation Outcome: Adoption [Time frame: 2-weeks, 4-weeks, 2-months, 3-months, 4-months, 5-months, 6-months, 9-months, 15-months]
  • Implementation Outcome: Fidelity and Sustainment - Observed [Time frame: Beginning of School Year, Mid-School Year, End of School Year]
  • Implementation Outcome: Fidelity and Sustainment - Self Report [Time frame: Baseline, 2-weeks, 4-weeks, 2-months, 3-months, 4-months, 5-months, 6-months, 9-months, 15-months]
  • Implementation Outcome: Reach [Time frame: Baseline, 2-weeks, 4-weeks, 2-months, 3-months, 4-months, 5-months, 6-months, 9-months, 15-months]
Secondary outcome measures (2)
  • Student Educational Outcomes [Time frame: 9-months]
  • Student Behavioral Outcomes [Time frame: Baseline, 2-weeks, 4-weeks, 2-months, 3-months, 4-months, 5-months, 6-months, 9-months, 15-months]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Health services research

Study locations

United States · 1 center
  • University of Washington — Seattle

Publications

  • 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

Identifiers

NCT: NCT05989568 · STUDY00017371

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗