Brief Intervention at Adult Education

NCT07102914 | Enrolling By Invitation

• 2 other identifiers: 20000402441R34MH139716-01
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 1

Brief Summary

Many Americans fail to receive their high school diploma. Individuals enrolled in Adult Education classes have exited the K-12 education system without a high school diploma. This reduces their access to economic resources, heightens their risk for poverty and poor health, limits their ability to meet occupational and social expectations of adult life, and exacerbates their stress. Behavioral health (i.e., depression, anxiety, anger, substance use) is implicated in K-12 school failure, as it negatively impacts students' acquisition of academic skills and their achievement of educational and vocational goals. Students enrolled in Adult Education Centers (AECs) are often ignored in most analyses that explore how behavioral health issues impact students' general functioning and academic outcomes, even though behavioral health challenges in AECs may be greater than that in the general population. AECs are ill equipped to address students' behavioral health challenges. Few evidence-based, behavioral health interventions are currently deployed in AECs that target the behavioral health challenges AEC students may experience. Screening, Brief Intervention, and Referral to Treatment (SBIRT), often informed by Motivational Interviewing (MI), positively impacts health outcomes. Positive outcomes are associated with the successful screening and referral to behavioral health services. In turn, these behavioral health improvements may also help to facilitate positive academic results for impacted AEC students. Implementation Facilitation is a promising strategy for ensuring the successful implementation of SBIRT in AECs. Guided by the integrated-Promoting Action on Research Implementation in Health Services (i-PARIHS) framework, the investigators propose an R34 project to: 1) conduct an iterative, mixed methods formative evaluation approach to identify barriers and facilitators of SBIRT implementation in AECs and tailor an Implementation Facilitation strategy to support the delivery of SBIRT to AEC students by SRSs; and 2) examine the acceptability, feasibility, and preliminary effectiveness of Implementation Facilitation to promote the use of SBIRT by SRSs with AEC students.

Conditions

Behavioral Health Challenges

Outcome Measures

Primary Outcomes (6)

• Patient-Reported Outcomes Measurement Information System (PROMIS) - Depression

  Behavioral measure of depression symptoms, Mild symptoms (T-score of 55\<\>60), moderate (T-score of 60\<\>65), and severe (T-score of 66\<) clinical thresholds

  pre-intervention, day 1; 3; 6 months

• Patient-Reported Outcomes Measurement Information System (PROMIS) - Anxiety

  Behavioral health measure, Mild symptoms (T-score of 55\<\>60), moderate (T-score of 60\<\>65), and severe (T-score of 66\<) clinical thresholds

  pre-intervention, day 1; 3; 6 months

• Patient-Reported Outcomes Measurement Information System (PROMIS) - Anger

  Behavioral Health Screening and Tracking measure, Mild symptoms (T-score of 55\<\>60), moderate (T-score of 60\<\>65), and severe (T-score of 66\<) clinical thresholds

  pre-intervention, day 1; 3; 6 months

• Patient-Reported Outcomes Measurement Information System (PROMIS) - Smoking

  Behavioral Health measure, Mild symptoms (T-score of 55\<\>60), moderate (T-score of 60\<\>65), and severe (T-score of 66\<) clinical thresholds

  pre-intervention, day 1; 3; 6 months

• Patient-Reported Outcomes Measurement Information System (PROMIS) - Substance Use

  Behavioral Health measure, Mild symptoms (T-score of 55\<\>60), moderate (T-score of 60\<\>65), and severe (T-score of 66\<) clinical thresholds

  pre-intervention, day 1; 3; 6 months

• Patient-Reported Outcomes Measurement Information System (PROMIS) - Alcohol Use

  Behavioral Health measure, Mild symptoms (T-score of 55\<\>60), moderate (T-score of 60\<\>65), and severe (T-score of 66\<) clinical thresholds

  pre-intervention, day 1; 3; 6 months

Secondary Outcomes (3)

• Client Satisfaction Questionnaire - 8 (CSQ-8)

  pre-intervention, day 1

• Academic attendance

  3 months post intervention and 6 months post intervention

• Intervention Usability Scale

  3 months post intervention and 6 months post intervention

Other Outcomes (1)

• Independent Tape Rate Scale

  Months 12-27

Study Arms (1)

Accessibility, feasibility and preliminary effectiveness

EXPERIMENTAL

The students will complete the Patient-Reported Outcomes Measurement Information Systems (PROMIS) measures, receive feedback from the SRSs about their behavioral health, receive a brief MI intervention, if indicated, and referral to community-based supports, as needed. This will continue at the start of each semester for 15 months to month 25. Student outcomes will be tracked at baseline and at 3- and 6-months post study enrollment. Main outcomes will be assessed according to the RE-AIM evaluation framework to capture both SRS-level (e.g., students reached wit SBIRT, adoption of SBIRT consistently, implemented SBIRT well) and student-level outcomes (e.g., retention; treatment referral engagement; changes in PROMIS measured scores; NHAEC program attendance, 12hr classroom instruction completed/received, credits earned). Acceptability of Implementation Facilitation and SBIRT will be determined for NHAEC staff, SRSs, and students (i.e., Client Satisfaction Questionnaire-8, CSQ-8

Behavioral: Screening, Brief Intervention and Referral for Treatment (SBIRT)

Interventions

Screening, Brief Intervention and Referral for Treatment (SBIRT) BEHAVIORAL

A single-arm, open pilot design maximizes the ability of the investigators to work collaboratively with NHAEC staff and administration to tailor the implementation strategy, establish the feasibility and acceptability of study methods and interventions (e.g., recruiting students, training SRSs to deliver SBIRT with integrity, response rates to assessment measures, student receipt of SBIRT, retention of SRSs and students), address the structural barriers within the AEC setting, identify the needs of the populations of interest, and gather data that points to best approaches to ensuring the study's success.

Accessibility, feasibility and preliminary effectiveness

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 17 years and currently enrolled either the High School Credit or General Educational Development programs.
• All eligible staff will be invited to participate in this study

You may not qualify if:

• students with acute psychosis or intoxication, low intellectual functioning.
• Not a staff at New Haven Adult Education

Sponsors & Collaborators

• Yale University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

New Haven Adult Education Center

New Haven, Connecticut, 06519, United States

Location

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MeSH Terms

Interventions

Mass Screening; Crisis Intervention; Referral and Consultation; Therapeutics

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice; Psychotherapy; Behavioral Disciplines and Activities; Professional Practice; Organization and Administration; Health Services Administration

Study Officials

• Derrick Gordon, Ph.D.

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Investigators will conduct a single-arm, open pilot study to examine the accessibility, feasibility, and preliminary effectiveness of Implementation Facilitation for the delivery of SBIRT by SRSs at NHAEC

Study Record Dates

• First Submitted: July 22, 2025
• First Posted: August 5, 2025
• Study Start: December 9, 2025
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Release of sub-sets of data will occur every 6 months, by 12 months after the completion of individual aims and portions of the study plan, concurrently with manuscript submission (within 6 months). Study data will be kept by OSF in perpetuity. OSF has a mechanism to maintain read-only data for at least 50 years, should funding for OSF as it currently operates cease to exist
• Access Criteria: Data that has been de-identified and made available via OSF will be available for public use. OSF requires the (free) creation of an account and agreement with its Terms of Use to access data. These data will be accessible without prior approval.

Locations

US (1)