Intervention AdoptionNCT03791281
Beliefs and Attitudes for Successful Implementation in Schools (BASIS)
A study testing BASIS in people with Intervention Adoption and Implementation, run by University of Washington at 1 site in United States.
Trial summary
The goal of this study is to adapt and test the feasibility and potential efficacy of a theory-driven pre-implementation intervention to address individual-level barriers to EBP implementation - Beliefs and Attitudes for Successful Implementation in Schools (BASIS) - designed to improve school mental health providers'… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Intervention Adoption, Implementation
- What is being tested?
- BASIS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2016to 31 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- School mental health providers (school psychologists, school social workers, etc.) recruited from middle and high schools in two economically and ethnically diverse districts in the Seattle area.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington School Mental Health Assessment, Research, and Training (SMART) Center
Seattle, Washington, 98115-8160
About this study
The goal of this study is to adapt and test the feasibility and potential efficacy of a theory-driven pre-implementation intervention to address individual-level barriers to EBP implementation - Beliefs and Attitudes for Successful Implementation in Schools (BASIS) - designed to improve school mental health providers' implementation of EBPs. BASIS is intended to be a feasible and scalable first-line or adjunctive implementation enhancement intervention that is facilitative of other efforts (e.g., organizational interventions) that target high quality EBP implementation. Aims of this study are to: (1) Adapt an existing, theory-driven implementation intervention (BASIS), previously used with educators, to improve the EBP implementation behaviors of school mental health providers; and (2) Assess the viability of a later clinical trial by: (a) establishing the feasibility, acceptability, and appropriateness of the BASIS intervention among school mental health providers, and (b) Pilot testing BASIS, as compared to an Attention Control, delivered as pre-implementation intervention prior to training in a specific, existing EBP. Key organizational factors (e.g., implementation climate) will also be evaluated and included as covariates and we will explore trends in the data to inform the design of a larger trial. Ultimately, BASIS offers an innovative and scalable approach to improving school mental health providers' uptake and use of EBPs in order to increase the number of youth with mental health problems who receive high quality services.
- Conditions
- Intervention Adoption, Implementation
- Being tested
- BASIS, Attention Control
- Keywords
- pre-implementation intervention, implementation strategy, individual-level barriers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BASISBehavioural
Attention ControlBehavioural
| Study group | Role | What they receive |
|---|---|---|
| BASIS | Experimental | Received a 3-hour BASIS implementation strategy. Receives: Behavioral: BASIS |
| Attention Control | Active comparator | Received a 3-hour session designed to control for dose, information provided, and presenter effects. Receives: Behavioral: Attention Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Attitudes toward Evidence-Based Practices
Evidence-Based Practice Attitudes Scale (EBPAS) is a widely used 26-item tool designed to assess evidence-based practice (EBP) attitudes with items measured on a 0-4 scale and 6 subscales: (1) likelihood of adopting if the EBP were a requirement; (2) likelihood of adopting if the EBP were appealing to you; (3) openness to new practices; (4) perceived divergence between current practices and EBPs; (5) fit of EBPs with current practices; and (6) burden of EBPs. Subscale and total scores are mean scores of items with a range of 0-4. Higher scores reflect more favorable attitudes (perceived divergence is reverse-coded).
Measured: Pre-intervention/baseline, post-intervention (1-2 weeks), 4-month follow-up
Change in Subjective Norms
Subjective Norms Scale is based on Theory of Planned Behavior (TPB) constructs. Two subscales measure two types implementation-related subjective norms: injunctive norms and descriptive norms. Four items load on each subscale and mean score range from -3 to +3, with positive scores reflecting more positive subjective injunctive and descriptive norms.
Measured: Pre-intervention/baseline, post-intervention (1-2 weeks), 4-month follow-up
Change in Perceived Behavioral Control
Perceived Behavioral Control Scale is a modified version of the Teacher's Self-Efficacy Scale, which has 10 items assessing perceived behavioral control in implementing evidence-based practices. Items are scored on a 1-4 scale with a total mean score ranging from 1-4. Higher scores reflect greater (i.e., more favorable) perceived behavioral control.
Measured: Pre-intervention/baseline, post-intervention (1-2 weeks), 4-month follow-up
Secondary outcomes (2)
Change in School Implementation Citizenship Behaviors
The School Implementation Citizenship Behaviors Scale (S-ICBS) includes 15 items and measures clinicians' perceptions of how school staff engage with evidence-based practices in their specific school context. There are 4 subscales: (1) helping others; (2) keeping informed; (3) taking initiative; and (4) advocacy. Subscale and total scores are mean scores of items with a range of 0-4. Higher scores reflect greater (i.e., more favorable) implementation citizenship behavior.
Measured: Pre-intervention/baseline, post-intervention (1-2 weeks), 4-month follow-up
Change in Intentions to Implement
The Modified Intentions to Use Scale has 9 items assessing school mental health providers' intentions to implement evidence-based practices. A total mean score is computed with a range of 0-4 and higher scores indicate more favorable intentions. Two versions of this scale were administered. At baseline, all providers were asked about general intentions to implement evidence-based practices. After training, clinicians were asked about intentions to implement the specific intervention for which they had received training.
Measured: Pre-intervention/baseline, post-intervention (1-2 weeks), 4-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2019
- Study start15 Aug 2016
- Primary completion31 Jul 2018
- Study completion31 Jul 2018
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 Intervention AdoptionStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Aaron Lyon, University of Washington
- Investigators
- Aaron R Lyon, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03791281
- Sponsor's protocol ID
- 52139
- Other IDs
- 1R21MH108714
- Status last verified
- Dec 2018
- First submitted
- 21 Dec 2018
- Last updated
- 2 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lyon AR, Cook CR, Duong MT, Nicodimos S, Pullmann MD, Brewer SK, Gaias LM, Cox S. The influence of a blended, theoretically-informed pre-implementation strategy on school-based clinician implementation of an evidence-based trauma intervention. Implement Sci. 2019 May 30;14(1):54. doi: 10.1186/s13012-019-0905-3.
PubMed 31146788
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beliefs and Attitudes for Successful Implementation in Schools (BASIS)
- ClinicalTrials.gov ID
- NCT03791281
- Acronym / sponsor ID
- 52139
- Conditions
- Intervention Adoption, Implementation
- Keywords
- pre-implementation intervention, implementation strategy, individual-level barriers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 15 Aug 2016 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 2 Jan 2019 (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.
The goal of this study is to adapt and test the feasibility and potential efficacy of a theory-driven pre-implementation intervention to address individual-level barriers to EBP implementation - Beliefs and Attitudes for Successful Implementation in Schools (BASIS) - designed to improve school mental health providers' implementation of EBPs. BASIS is intended to be a feasible and scalable first-line or adjunctive implementation enhancement intervention that is facilitative of other efforts (e.g., organizational interventions) that target high quality EBP implementation. Aims of this study are to: (1) Adapt an existing, theory-driven implementation intervention (BASIS), previously used with educators, to improve the EBP implementation behaviors of school mental health providers; and (2) Assess the viability of a later clinical trial by: (a) establishing the feasibility, acceptability, and appropriateness of the BASIS intervention among school mental health providers, and (b) Pilot testing BASIS, as compared to an Attention Control, delivered as pre-implementation intervention prior to training in a specific, existing EBP. Key organizational factors (e.g., implementation climate) will also be evaluated and included as covariates and we will explore trends in the data to inform the design of a larger trial. Ultimately, BASIS offers an innovative and scalable approach to improving school mental health providers' uptake and use of EBPs in order to increase the number of youth with mental health problems who receive high quality services.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BASIS | Experimental | Behavioral: BASISReceived a 3-hour BASIS implementation strategy. |
| Attention Control | Active comparator | Behavioral: Attention ControlReceived a 3-hour session designed to control for dose, information provided, and presenter effects. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- School mental health providers (school psychologists, school social workers, etc.) recruited from middle and high schools in two economically and ethnically diverse districts in the Seattle area.
Key exclusion criteria (0 listed)
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 | Behavioural | BASIS |
| Attention Control | Behavioural | Attention Control |
Primary outcome
Change in Attitudes toward Evidence-Based Practices
Time frame: Pre-intervention/baseline, post-intervention (1-2 weeks), 4-month follow-up
Evidence-Based Practice Attitudes Scale (EBPAS) is a widely used 26-item tool designed to assess evidence-based practice (EBP) attitudes with items measured on a 0-4 scale and 6 subscales: (1) likelihood of adopting if the EBP were a requirement; (2) likelihood of adopting if the EBP were appealing to you; (3) openness to new practices; (4) perceived divergence between current practices and EBPs; (5) fit of EBPs with current practices; and (6) burden of EBPs. Subscale and total scores are mean scores of items with a range of 0-4. Higher scores reflect more favorable attitudes (perceived divergence is reverse-coded).
Change in Subjective Norms
Time frame: Pre-intervention/baseline, post-intervention (1-2 weeks), 4-month follow-up
Subjective Norms Scale is based on Theory of Planned Behavior (TPB) constructs. Two subscales measure two types implementation-related subjective norms: injunctive norms and descriptive norms. Four items load on each subscale and mean score range from -3 to +3, with positive scores reflecting more positive subjective injunctive and descriptive norms.
Change in Perceived Behavioral Control
Time frame: Pre-intervention/baseline, post-intervention (1-2 weeks), 4-month follow-up
Perceived Behavioral Control Scale is a modified version of the Teacher's Self-Efficacy Scale, which has 10 items assessing perceived behavioral control in implementing evidence-based practices. Items are scored on a 1-4 scale with a total mean score ranging from 1-4. Higher scores reflect greater (i.e., more favorable) perceived behavioral control.
2 secondary outcomes
Change in School Implementation Citizenship Behaviors
Time frame: Pre-intervention/baseline, post-intervention (1-2 weeks), 4-month follow-up
Change in Intentions to Implement
Time frame: Pre-intervention/baseline, post-intervention (1-2 weeks), 4-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2019.
- Derived from this study: PubMed 31146788Lyon AR, Cook CR, Duong MT, Nicodimos S, Pullmann MD, Brewer SK, Gaias LM, Cox S. The influence of a blended, theoretically-informed pre-implementation strategy on school-based clinician implementation of an evidence-based trauma intervention. Implement Sci. 2019 May 30;14(1):54. doi: 10.1186/s13012-019-0905-3.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Aaron R 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 in people with Intervention Adoption and Implementation, 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 0 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: finished, as of the sponsor's last update on 2 Jan 2019. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Attitudes toward Evidence-Based Practices (time frame: Pre-intervention/baseline, post-intervention (1-2 weeks), 4-month follow-up). The study lists 3 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 NCT03791281, 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 2 Jan 2019.