Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05989568
Other study ID # STUDY00017371
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 8, 2023
Est. completion date July 31, 2026

Study information

Verified date October 2023
Source University of Washington
Contact Aaron Lyon, PhD
Phone 206-221-8604
Email lyona@uw.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 276
Est. completion date July 31, 2026
Est. primary completion date July 1, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.
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 in professional development training for teachers.

Locations

Country Name City State
United States University of Washington Seattle Washington

Sponsors (2)

Lead Sponsor Collaborator
University of Washington Institute of Education Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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 Student Educational Outcomes Schools will complete a survey on student educational outcomes for the year, including questions related to grades, test scores, and attendance. There is no reporting on a scale. 9-months
Secondary Student Behavioral Outcomes Survey measure including questions related to classroom on-task behavior, classroom disruptive behavior, and classroom prosocial behavior. These questions all are part of the same scale. Baseline, 2-weeks, 4-weeks, 2-months, 3-months, 4-months, 5-months, 6-months, 9-months, 15-months
See also
  Status Clinical Trial Phase
Recruiting NCT05525962 - Vulnerability/Resilience Factors Influencing the Developmental Trajectories and Adaptive Methods of Children and Adolescents in Child Welfare System.
Recruiting NCT05987761 - PRT for Adolescents With High Functioning Autism N/A
Active, not recruiting NCT05264415 - Intergenerational Transmission of Traumatic Stress N/A
Recruiting NCT05858593 - Positive Youth Development in the Metaverse N/A
Recruiting NCT04565210 - Effects of Oriental Music on Preterm Infants N/A
Completed NCT03728894 - Oral Sedation With and Without Nitrous Oxide Phase 3
Active, not recruiting NCT04609553 - Literacy Promotion for Latinos Study N/A
Active, not recruiting NCT05403996 - Effects of an Active Break Program at Primary School N/A
Completed NCT05681832 - Developing a Physical Activity Program Based on Behavior Change Models in Children and Investigation of Its Efficiency N/A
Recruiting NCT05201534 - Interventions in Mathematics and Cognitive Skills N/A
Completed NCT03980067 - Impact of Pre-Sedation Virtual Reality Game on Post-Discharge Negative Behaviors in the Pediatric Emergency Department N/A
Enrolling by invitation NCT05189769 - Reducing Racism and Discrimination in Schools: Comprehensive Prevention Services N/A
Recruiting NCT04824989 - Parents Advancing Toddler Health N/A
Recruiting NCT05585905 - Virtual Reality in Pediatric Dentistry N/A
Completed NCT05302154 - Effect of Virtual Reality on Dental Anxiety in Children N/A
Completed NCT05592587 - Pain and Anxiety Reduction Using a Vibrating Eye Massage Device With Relaxing Nature Sounds N/A
Not yet recruiting NCT05839548 - Articaine Efficacy and Safety for 3 Years Old Children Phase 3
Completed NCT04927754 - Effect of Cartoon-assisted Visual/Auditory Distraction Method in Paediatric Dental Patients N/A
Completed NCT04000230 - Teacher Child Interaction Training (TCIT): Randomized Control Trial N/A
Enrolling by invitation NCT05020041 - Change Physical Activity and School Play Space. Randomized Study Protocol. N/A