Clinical trial NCT06672835: BASIS Optimization
Official title: Beliefs and Attitudes for Successful Implementation in Schools (BASIS) Optimization
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mental Health
Health Services
Evidence Based Programs in Schools
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: University of Kansas
name: National Institute of Mental Health (NIMH)
First posted: 2024-11-04
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Evidence-Based Practice Attitude Scale (EBPAS)
timeFrame: Baseline, immediately after training, 2 weeks after training, 1 month after training, 2 months after training, 3 months after training
measure: Subjective Norms
timeFrame: Baseline, immediately after training, 2 weeks after training, 1 month after training, 2 months after training, 3 months after training
measure: Outcome Expectancies
timeFrame: Baseline, immediately after training, 2 weeks after training, 1 month after training, 2 months after training, 3 months after training
measure: Action Self-Efficacy
timeFrame: Baseline, immediately after training, 2 weeks after training, 1 month after training, 2 months after training, 3 months after training
measure: Maintenance Self-Efficacy
timeFrame: immediately after training, 2 weeks after training, 1 month after training, 2 months after training, 3 months after training
measure: Perceived Needs
timeFrame: Baseline, immediately after training, 2 weeks after training, 1 month after training, 2 months after training, 3 months after training
measure: Modified Intention to Implement Scale (MIIS)
timeFrame: Baseline, immediately after training, 2 weeks after training, 1 month after training, 2 months after training, 3 months after training
measure: Intervention Usability Scale (IUS)
timeFrame: immediately after training, 2 weeks after training, 1 month after training, 2 months after training, 3 months after training
measure: Action Plan
timeFrame: immediately after training, 2 weeks after training, 1 month after training, 2 months after training, 3 months after training
measure: Coping Plan
timeFrame: immediately after training, 2 weeks after training, 1 month after training, 2 months after training, 3 months after training
Secondary outcomes:
measure: School Implementation Leadership Scale (S-ILS)
timeFrame: 2 weeks after training
measure: School Implementation Climate Scale (S-ICS)
timeFrame: 2 weeks after training
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Aaron Lyon, PhD
role: PRINCIPAL_INVESTIGATOR
References: