Strengthening Health and Insight in New Educators (SHINE)

March 31, 2025 updated by: Summer Braun, University of Alabama, Tuscaloosa

Healthy Minds for Pre-Service Teachers

Teachers are at notable risk for depression and anxiety. The present study tests an app-based mindfulness intervention for teachers in their final year of training with the goal of preventing the deterioration of their mental health during the transition into the classroom. The project will strengthen the research environment at the University of Alabama and will involve undergraduate research assistants in each step of the research process.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Mental health concerns in teachers have escalated since the onset of the pandemic, and the deterioration of mental health can begin as early as the teacher training period. Accessible and scalable programs that prepare teachers for the stress of the profession are urgently needed to prevent the deterioration of mental health and its attendant consequences. The goal of this longitudinal project is to test the feasibility and acceptability, utility, and candidate mechanisms of an accessible, mobile health, mindfulness-based intervention, the Healthy Minds Program (HMP), to equip teachers in training ("pre-service teachers"; i.e., university students majoring in education) with skills necessary to maintain their mental health as they transition into the classroom. The project addresses three specific aims. Aim 1: a) Assess the feasibility and acceptability of the HMP for pre-service teachers and b) identify barriers and facilitators to program acceptability. Aim 2: Determine the utility of the HMP for preventing depression and anxiety (main outcomes) and turnover intentions (secondary outcome). Aim 3: Examine HMP effects on candidate mechanisms, and the effect of mechanisms on outcomes. The results of this project will provide critical insight into the potential for the HMP to scale up for widespread use in pre-service teacher training programs. Importantly, the project will provide a unique opportunity for undergraduate research at the University of Alabama, and will strengthen the research environment by involving undergraduate research assistants in each step of the research process.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
140

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Summer S Braun, Ph.D.
  • Phone Number: 2053486159
  • Email: ssbraun@ua.edu

Study Contact Backup

  • Name: Alison L Hooper, Ph.D.
  • Phone Number: 205-348-0303
  • Email: alhooper2@ua.edu

Study Locations

  • United States
    • Alabama
      • Tuscaloosa, Alabama, United States, 35487
        • Recruiting
        • University of Alabama
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Students in Block 3 will be invited to participate in the study.

Exclusion Criteria:

  • Students who are not in Block 3 will be excluded. Participants experiencing suicidal ideations at baseline and deemed via the clinical risk assessment procedure to be at moderate or high risk of suicide will be excluded from the study after baseline, and prior to randomization.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Business as Usual
Participants in this arm will continue with daily life as usual.
Experimental: Healthy Minds Program
Participants in this arm engage with the Healthy Minds Program app.
Behavioral: Healthy Minds Program
Participants in this arm engage with the Healthy Minds Program app/

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Patient-Reported Outcomes Measurement Information System (PROMIS) Depression - Short Form 8b
Time Frame: Participants will report on depression at baseline, post-intervention (3 months after baseline), 3-month follow-up , and 12-month follow-up.
Participants will self-report on depression. Each of the 8 items is rated on 1 (1 = Never) to 5 (5 = Always) scale. Responses will be summed to create the raw scale score. Higher values indicate greater symptoms of depression (i.e., a worse outcome).
Participants will report on depression at baseline, post-intervention (3 months after baseline), 3-month follow-up , and 12-month follow-up.
Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety - Short Form 7a
Time Frame: Participants will report on anxiety at baseline, post-intervention (3 months after baseline), 3-month follow-up, and 12-month follow-up.
Participants will self-report on anxiety. Each of the 7 items is rated on 1 (1 = Never) to 5 (5 = Always) scale. Responses will be summed to create the raw scale score. Higher values indicate greater symptoms of anxiety (i.e., a worse outcome).
Participants will report on anxiety at baseline, post-intervention (3 months after baseline), 3-month follow-up, and 12-month follow-up.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Turnover Intentions
Time Frame: Participants will report turnover intentions at 3-month follow-up, and 12-month follow-up.
Participants will self-report on their intentions to leave their job.
Participants will report turnover intentions at 3-month follow-up, and 12-month follow-up.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Teaching Quality: edTPA
Time Frame: edTPA scores will be collected immediately after the intervention.
Performance-based assessment of teaching quality required for teacher certification. Higher scores indicate greater teaching quality.
edTPA scores will be collected immediately after the intervention.
Teaching Quality: Candidate Preservice Assessment of Student Teaching (CPAST)
Time Frame: CPAST scores will be collected immediately after the intervention.
Summative assessment of pre-service teachers' teaching quality during the semester-long student teaching experience. Higher scores indicate greater teaching quality.
CPAST scores will be collected immediately after the intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Alabama, Tuscaloosa

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 17, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 12, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 2, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 24-01-7242
  • R15MH134225 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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