Behavior, ChildBASIS-TNCT05989568
BASIS-T Efficacy Trial
A study testing BASIS-T in people with Behavior, Child, run by University of Washington at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Behavior, Child
- What is being tested?
- BASIS-T
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 276 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2023to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being a K-5th grade teacher at an elementary or K-8 school, and not a teacher in a special education-only classroom
Who cannot join
- Having been trained or supervised on delivering PGD in the past 5 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mike Pullmann, PhD contact
United States1 site, 1 recruiting
- Recruiting
University of Washington
Seattle, Washington, 98115
Aaron Lyon, PhD
About this study
Official title: Supporting Teachers in Implementing Classroom Practices to Build Better Student-Teacher Relationships
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
- Being tested
- BASIS-T, Attention Control (ACC)
- Medical subject headings
- Child Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BASIS-TBehavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Attention Control (ACC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: 9-months
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.
Measured: Baseline, 2-weeks, 4-weeks, 2-months, 3-months, 4-months, 5-months, 6-months, 9-months, 15-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start8 Aug 2023
- Primary completion1 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Behavior, ChildStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 276 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Education Sciences
- Responsible party
- Principal investigator, Aaron Lyon, University of Washington
- Investigators
- Aaron Lyon, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05989568
- Sponsor's protocol ID
- STUDY00017371
- Acronym
- BASIS-T
- Status last verified
- Dec 2024
- First submitted
- 30 May 2023
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data obtained during the BASIS-T study will be provided to researchers who have demonstrated an academic interest in educational services, in-school mental health services, or in implementation sciences. Outside investigators who wish to use the data set to answer new research questions may also submit data analysis concept proposals for consideration by the PI on a case-by-case basis. The PI will review the proposal and will provide those who submit scientifically rigorous and promising proposals access to the data repository to address their research questions. This will ensure that the data resources of the proposed study will provide the greatest possible benefit to the scientific community. Data samples that may be shared will be coded based on study design, and all personal health and identifying will be removed. Prerequisite to data sharing, the PI will require applicable agreements (i.e., data transfer agreements) with the requesting entity.
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.
PubMed 38167046
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supporting Teachers in Implementing Classroom Practices to Build Better Student-Teacher Relationships
- ClinicalTrials.gov ID
- NCT05989568
- Acronym / sponsor ID
- BASIS-T / STUDY00017371
- Conditions
- Behavior, Child
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 276 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Institute of Education Sciences
- Study start
- 8 Aug 2023 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BASIS-T | Experimental | Behavioral: BASIS-TBASIS-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 | Placebo comparator | 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 in professional development training for teachers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Being a K-5th grade teacher at an elementary or K-8 school, and not a teacher in a special education-only classroom
Key exclusion criteria (1 listed)
- Having been trained or supervised on delivering PGD in the past 5 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BASIS-TBASIS-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. | Behavioural | BASIS-T |
| 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. | Behavioural | Attention Control |
Primary outcome
Proximal Outcome: Attitudes
Time frame: Baseline, 2-weeks, 4-weeks, 2-months, 3-months, 4-months, 5-months, 6-months, 9-months, 15-months
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.
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
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.
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
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.
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
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.
Implementation Outcome: Adoption
Time frame: 2-weeks, 4-weeks, 2-months, 3-months, 4-months, 5-months, 6-months, 9-months, 15-months
Adoption data will be gathered via monthly self-report checklist of fidelity. Minimum Score 0, Maximum Score 15. Higher Scores mean better outcome.
Implementation Outcome: Fidelity and Sustainment - Observed
Time frame: Beginning of School Year, Mid-School Year, End of School Year
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.
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
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.
Implementation Outcome: Reach
Time frame: Baseline, 2-weeks, 4-weeks, 2-months, 3-months, 4-months, 5-months, 6-months, 9-months, 15-months
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.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
- Derived from this study: PubMed 38167046Lyon 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.
- Individual participant dataSharing planned: Yes. Data obtained during the BASIS-T study will be provided to researchers who have demonstrated an academic interest in educational services, in-school mental health services, or in implementation sciences. Outside investigators who wish to use the data set to answer new research questions may also submit data analysis concept proposals for consideration by the PI on a case-by-case basis. The PI will review the proposal and will provide those who submit scientifically rigorous and promising proposals access to the data repository to address their research questions. This will ensure that the data resources of the proposed study will provide the greatest possible benefit to the scientific community. Data samples that may be shared will be coded based on study design, and all personal health and identifying will be removed. Prerequisite to data sharing, the PI will require applicable agreements (i.e., data transfer agreements) with the requesting entity.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mike Pullmann, PhD contact
Aaron Lyon, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BASIS-T in people with Behavior, Child, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aaron Lyon, PhD (206-221-8604, lyona@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proximal Outcome: Attitudes (time frame: Baseline, 2-weeks, 4-weeks, 2-months, 3-months, 4-months, 5-months, 6-months, 9-months, 15-months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05989568, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2024.