BASIS Optimization

NCT ID: NCT06672835

Last Updated: 2024-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-05

Study Completion Date

2025-07-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The objective of the BASIS R34 pilot study is to test the impact of eBASIS in a randomized controlled trial (RCT). Consistent with IMPACT's IQM, the study tests effects of eBASIS on treatment fidelity and youth outcomes, compared to a digitally delivered control (N=32 clinicians; 96 clients). A well-established EBP (Cognitive Behavioral Therapy Plus), will be a focus of the investigation, which eligible participants will already be signed up to receive.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Although evidence-based practices (EBPs) have been extensively developed, they are not widely used in school settings, where up to 80% of youth receive mental health services. This results in reduced impact on youth mental health. The project aims to test the online version of efficient and effective strategy called BASIS to improve the quality of EBP by focusing on individual-level processes, complementing organizational change approaches.

The strategy applies the Theory of Planned Behavior (TPB) to influence key provider behaviors, such as attitudes, subjective norms, and perceived behavioral control, which are central to EBP adoption and fidelity. Preliminary trials on BASIS found significant changes in key theory of planned behavior mechanisms (e.g., attitudes, perceived behavioral control, and social norms) and more engagement in post-training consultation among school school-based clinicians, supporting implementation of evidenced-based social-emotional-behavioral practices. By addressing the intrapersonal mechanisms driving provider decisions, the study aims to improve implementation outcomes in school settings.

The objective of this pilot study is to test the impact of the optimized eBASIS in a randomized controlled trial (RCT). Consistent with IMPACT's IQM, the study tests effects of eBASIS on treatment fidelity and youth outcomes, compared to a digitally delivered control (N=32 clinicians; 96 clients). A well-established EBP (Cognitive Behavioral Therapy Plus), will be a focus of the investigation, which eligible participants will already be signed up to receive.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mental Health Health Services Evidence Based Programs in Schools

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The intervention study model is parallel where participants will be randomly assigned to the experimental group (n=16) and the active comparator group (n=16).
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

eBASIS

eBASIS is an online, optimized, and evidence-based practice agnostic implementation strategy that addresses the behavioral component often missing from standard evidence-based practice training and consultation. It relates to motivation before and volition after the evidence-based practice training and targets behavioral intentions by improving attitudes, subjective norms, and self-efficacy. The implementation strategy is designed to be designed to be delivered within the Preparation/Adoption phase immediately prior to the Action implementation in the EPIS model.

Group Type EXPERIMENTAL

eBASIS

Intervention Type BEHAVIORAL

eBASIS is an online, optimized, and evidence-based practice agnostic implementation strategy that addresses the behavioral component often missing from standard evidence-based practice training and consultation. It relates to motivation before and volition after the evidence-based practice training and targets behavioral intentions by improving attitudes, subjective norms, and self-efficacy. The implementation strategy is designed to be designed to be delivered within the Preparation/Adoption phase immediately prior to the Action implementation in the EPIS model.

eAttention Control

eAC is an online control for eBASIS. Providers assigned to eAttention Control (eAC) will receive pre- and post-training experiences designed to mirror those received in eBASIS. These training experiences will be delivered on the same platform and be approximately the same length as the eBASIS but will not contain any eBASIS content or mechanisms of change. The eAC pre-training experience will define, describe, and advocate for evidence-based practice implementation in schools. Content in eAC will be didactic similar to a typical professional development training for providers.

Group Type PLACEBO_COMPARATOR

eAttention Control

Intervention Type BEHAVIORAL

eAC is an online control for eBASIS. Providers assigned to eAttention Control (eAC) will receive pre- and post-training experiences designed to mirror those received in eBASIS. These training experiences will be delivered on the same platform and be approximately the same length as the eBASIS but will not contain any eBASIS content or mechanisms of change. The eAC pre-training experience will define, describe, and advocate for evidence-based practice implementation in schools. Content in eAC will be didactic similar to a typical professional development training for providers.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

eBASIS

eBASIS is an online, optimized, and evidence-based practice agnostic implementation strategy that addresses the behavioral component often missing from standard evidence-based practice training and consultation. It relates to motivation before and volition after the evidence-based practice training and targets behavioral intentions by improving attitudes, subjective norms, and self-efficacy. The implementation strategy is designed to be designed to be delivered within the Preparation/Adoption phase immediately prior to the Action implementation in the EPIS model.

Intervention Type BEHAVIORAL

eAttention Control

eAC is an online control for eBASIS. Providers assigned to eAttention Control (eAC) will receive pre- and post-training experiences designed to mirror those received in eBASIS. These training experiences will be delivered on the same platform and be approximately the same length as the eBASIS but will not contain any eBASIS content or mechanisms of change. The eAC pre-training experience will define, describe, and advocate for evidence-based practice implementation in schools. Content in eAC will be didactic similar to a typical professional development training for providers.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Mental health provider who spends 2 hours or more providing supports in school setting
* Registered to receive CBT+ training from the WA State EBP Initiative

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Kansas

OTHER

Sponsor Role collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Aaron Lyon

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Aaron Lyon, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Washington

Seattle, Washington, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Aaron Lyon, PhD

Role: CONTACT

206-221-8604

Maria Hugh, PhD

Role: CONTACT

785-864-1143

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Aaron Lyon, PhD

Role: primary

206-221-8604

Maria Hugh, PhD

Role: backup

785-864-1143

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

5P50MH126219-04

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00021393

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

New Technology and Child Health
NCT02622035 COMPLETED NA