Brief Intervention at Adult Education
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Screening, Brief Intervention and Referral for Treatment (SBIRT).
- Who it may be relevant to
- Registry conditions: Behavioral Health Challenges. Basic parameters: from 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Building Effective Evidence-Based Services at New Haven Adult Education
Overview
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.
Detailed description
Twenty-eight million (13%) adults 25 years and older in the United States, 368,000 (16%) in Connecticut, and 94,000 (17%) in New Haven County do not have a high school diploma. Behavioral health (i.e., depression, anxiety, anger, substance use) are implicated in high rates K-12 school failure. Failure to graduate from high school confers significant social, financial, and personal challenges that undermine one's ability to meet life expectations. Adult Education Centers (AECs) are designed to help individuals reenter the learning environment and achieve their educational-vocational goals (i.e., a high school diploma). AECs' observe significant student "churning" (i.e., students entering and exiting without goal achievement). Student Retention Specialists (SRSs) in AECs are charged with engaging and retaining students. SRSs, however, do not receive training in evidence-based interventions to address students' behavioral health, including referring students to specialized treatment. Such training could help the SRSs increase AEC students' successful completion of their educational-vocational goals.
Using motivational interviewing-informed Screening, Brief Intervention, and Referral to Treatment (SBIRT) within AECs, for students, holds promise to address the behavioral health challenges they experience. SBIRT can be delivered effectively by paraprofessionals with good clinical outcomes, including improvement in physical health, reductions in substance misuse, better behavioral and emotional functioning, increased self-efficacy, positive expectations for success, and increased academic motivation and continuation. How best to implement SBIRT in community settings like AECs is unknown and requires a formative evaluation process that identifies key determinants of SBIRT implementation in AECs using a modified Implementation Facilitation strategy that supports students' positive behavioral health and academic outcomes.
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. Implementation Facilitation aligns with the factors considered in i-PARIHS, including attention to characteristics of the providers, recipients, and context.
This project will include a 1) developmental, formative evaluation before the single-arm open pilot study to identify barriers and facilitators to implementing SBIRT in an AEC, with attention to unique, contributing, factors; and 2) a progress-focused formative evaluation during the pilot study to identify factors that inform modifications needed for Implementation Facilitation in NHAEC to enhance its capacity to achieve designated study outcomes. This two-part formative evaluation will involve staff and students. Forty staff will be enrolled (20 for the developmental, 20 for the progress-focused formative evaluations) from full-time (n=32; 35+ hours week), part-time employees (n=55; \<= 19 hours week) and administrative staff (n=3; 35+ hours week). The Investigators will attend to demographic (e.g., age, race, ethnicity, sex) and schedule (daytime, evening) distributions to obtain a representative sample. All eligible staff will be invited to complete the ORCA assessments (see below) as part of the developmental and progress-focused formative evaluations. NHAEC staff will be required to have been employed by for at least one year to ensure sufficient experience with the setting.
Forty students (20 each for the developmental and progress-focused formative evaluations) will be enrolled. Inclusion criteria: ≥ 17 years and currently enrolled either the High School Credit or General Educational Development programs. Exclusion criteria: students with acute psychosis or intoxication, low intellectual functioning. For these students, study enrollment will be deferred until they are no longer impaired and are able to understand what is expected. The investigators will strive to recruit a representative sample or students across demographics (e.g., age, race, ethnicity, sex) and program type (High School Credit, General Educational Development; daytime, nighttime) using the previous year's enrollment proportions. The i-PARIHS framework will guide the development of interview guides for the staff and student focus groups and administrator key informant interviews. After consenting to participate in the focus groups, the participants will complete demographic questionnaires. They will then be introduced to the facilitators and provided a high-level summary of the background for the focus group, including its goal of understanding their perspectives. Specifically, participants will be asked about their perceptions about the intervention (e.g., degree of fit with existing practices and values, usability to achieve desired goals with noticeable results), recipient characteristics, (e.g., motivation, values, beliefs and goals, skills and knowledge, available resources, opinion leader endorsement), inner contexts (e.g., leadership support, institutional culture supporting practice change, learning environment supporting SBIRT adoption), outer contexts (e.g., NHAEC policies and priorities, inter-organizational networks and relationships), and facilitation efforts (e.g., roles and activities at NHAEC that might support SBIRT implementation). They will be informed about the expectations around confidentiality and not sharing with others what is discussed in the focus group. During the interviews, students and staff will be presented with information (e.g., NHAEC student observed behavioral health concerns, disparity between number of students registered and those that meet minimum instructional requirements) and asked to react to the information presented. Interviews with staff and students will also explore their unique perceptions of: 1) the behavioral health needs of students attending NHAEC and how these unmet needs impact students' educational achievements; 2) NHAEC students' prior experiences receiving support; 3) how to meet these needs, with consideration of SBIRT as part of the process; 4) barriers and facilitators to implementing SBIRT in AECs; and 5) factors that may contribute to challenges experienced regarding behavioral health, access to care, and educational goal attainment. Study PI and Co-I, Dr. Kaufman, will develop the interview protocol by attending to the overlapping and unique focus for each of the groups (staff, students). Key informant interviews will be conducted by trained researchers during an encrypted Zoom call. The researchers were trained in qualitative interview techniques by Co-I Kaufman. In addition, each researcher will conduct at least one practice interview with the co-I who will provide feedback. All interviews will be audio-recorded and transcribed using HIPPA compliant Zoom, with all identifiable data removed. Qualitative data analyses will be conducted by the PI and Co-I, Dr. Kaufman using an inductive, analytic approach guided by the i-PARIHS framework. The investigators will independently review the transcripts and generate initial open codes. The investigators will then meet to review the codes that emerged and develop a draft code book that will include operation definitions and instructions to employ each code. Next each researcher will independently code two transcripts and meet to discuss coding decisions and reach consensus on codes, identify new codes that emerged from the data, and finalize the codebook. Two researchers will independently code each transcript and then meet to reach consensus. Co-I Kaufman will review all transcripts to assess agreement with codes and confer with coders as needed. The codes and codebook will be shared in co-design meeting with select staff, SRSs, and administration to facilitate consensus on salient components emerging from the data. NVivo will allow for assessment of intercoder reliability, increase the credibility of the coding process, and allow the team to identify any coder drift. In addition, themes will be identified and reviewed and will continue until thematic saturation of content is achieved. The analyses procedures described will be used for both the Developmental and Progress-Focused Formative Evaluations. Associated demographic and quantitative data from the focus group participants will be stored in REDCap files. The collection of data from multiple informants, iterative processing of data collected, and analysis and use of two researchers to code transcripts, increases the creditability, transferability, dependability, and confirmability of the findings. NHAEC focus group interview staff participants will complete a questionnaire to characterize their demography and AEC work experience. All staff will be invited to complete the Organizational Readiness for Change Assessment (ORCA) measure focused on factors potentially affecting SBIRT implementation, including the respondents' perceptions of the 1) evidence for SBIRT, 2) quality of the implementation context for SBIRT, and 3) the degree to which the facilitation activities support SBIRT implementation. These scales have good internal consistency and factor structure and are based on the i-PARIHS framework. The developmental formative evaluation will only include the evidence and context sections of the ORCA, as Implementation Facilitation will not be experienced by the staff until the single-arm open pilot study has commenced. The progress-focused formative evaluation will include the evidence, context, and facilitation sections of the ORCA. The formative evaluation results will be critical for distilling Implementation Facilitation activities that work best for establishing SBIRT as a practice in AECs and evolving them with the experience gained during the pilot study. Quantitative data analyses will be conducted by the PI and Co-I Kershaw and will include summarized descriptive statistics for the demographic measures. For the ORCA assessments, the investigators will also compute descriptive statistics for the ORCA items and scale scores for the evidence, context, and facilitation scales (assessed during the progress-focused formative evaluation during the pilot feasibility study). Assuming participation of most NHAEC staff, all available data and generalized estimating equation (GEE), an extension of the generalized linear model (GLM) that will allow for the analysis of quantitative data closeted by the NHAEC program (High School Credit or General Education Development) and respondent will be used to document change in ORCA scores from the developmental to the progress-focused formative evaluation. GEE can be used in the analysis of continuous data even then they are not normally distributed. The investigators will triangulate the qualitative interviews and quantitative ORCA assessment data for both the developmental and progress-focused formative evaluations. First, the investigators will used a mixed methods approach to compare responses on the ORCA survey with cross-cutting themes represented in the interview transcripts. Second, the investigators will "follow threads," namely examine themes that cut across the two formative evaluation periods to understand factors that need further consideration and modification to best facilitate the implementation of SBIRT at NHAEC.
The proposed research focuses on developing an Implementation Facilitation approach appropriate for AEC settings. A single-arm, open pilot design maximizes the ability of the investigators to work collaboratively with NHAEC staff and administratio
Interventions
- Behavioral Screening, Brief Intervention and Referral for Treatment (SBIRT)
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
Primary outcome measures
- Patient-Reported Outcomes Measurement Information System (PROMIS) - Depression [Time frame: pre-intervention, day 1; 3; 6 months]
- Patient-Reported Outcomes Measurement Information System (PROMIS) - Anxiety [Time frame: pre-intervention, day 1; 3; 6 months]
- Patient-Reported Outcomes Measurement Information System (PROMIS) - Anger [Time frame: pre-intervention, day 1; 3; 6 months]
- Patient-Reported Outcomes Measurement Information System (PROMIS) - Smoking [Time frame: pre-intervention, day 1; 3; 6 months]
- Patient-Reported Outcomes Measurement Information System (PROMIS) - Substance Use [Time frame: pre-intervention, day 1; 3; 6 months]
- Patient-Reported Outcomes Measurement Information System (PROMIS) - Alcohol Use [Time frame: pre-intervention, day 1; 3; 6 months]
Secondary outcome measures (3)
- Client Satisfaction Questionnaire - 8 (CSQ-8) [Time frame: pre-intervention, day 1]
- Academic attendance [Time frame: 3 months post intervention and 6 months post intervention]
- Intervention Usability Scale [Time frame: 3 months post intervention and 6 months post intervention]
Eligibility criteria
Inclusion criteria
- ≥ 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
Exclusion criteria
- students with acute psychosis or intoxication, low intellectual functioning.
- Not a staff at New Haven Adult Education
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Screening
Study locations
United States · 1 center
- New Haven Adult Education Center — New Haven
Publications
- Glasgow RE, Harden SM, Gaglio B, Rabin B, Smith ML, Porter GC, Ory MG, Estabrooks PA. RE-AIM Planning and Evaluation Framework: Adapting to New Science and Practice With a 20-Year Review. Front Public Health. 2019 Mar 29;7:64. doi: 10.3389/fpubh.2019.00064. eCollection 2019. PMID 30984733
- Cook KF, Jensen SE, Schalet BD, Beaumont JL, Amtmann D, Czajkowski S, Dewalt DA, Fries JF, Pilkonis PA, Reeve BB, Stone AA, Weinfurt KP, Cella D. PROMIS measures of pain, fatigue, negative affect, physical function, and social function demonstrated clinical validity across a range of chronic conditions. J Clin Epidemiol. 2016 May;73:89-102. doi: 10.1016/j.jclinepi.2015.08.038. Epub 2016 Mar 4. PMID 26952842
- Schalet BD, Pilkonis PA, Yu L, Dodds N, Johnston KL, Yount S, Riley W, Cella D. Clinical validity of PROMIS Depression, Anxiety, and Anger across diverse clinical samples. J Clin Epidemiol. 2016 May;73:119-27. doi: 10.1016/j.jclinepi.2015.08.036. Epub 2016 Feb 27. PMID 26931289
- Reeve BB, Hays RD, Bjorner JB, Cook KF, Crane PK, Teresi JA, Thissen D, Revicki DA, Weiss DJ, Hambleton RK, Liu H, Gershon R, Reise SP, Lai JS, Cella D; PROMIS Cooperative Group. Psychometric evaluation and calibration of health-related quality of life item banks: plans for the Patient-Reported Outcomes Measurement Information System (PROMIS). Med Care. 2007 May;45(5 Suppl 1):S22-31. doi: 10.1097/ PMID 17443115
- DeWalt DA, Rothrock N, Yount S, Stone AA; PROMIS Cooperative Group. Evaluation of item candidates: the PROMIS qualitative item review. Med Care. 2007 May;45(5 Suppl 1):S12-21. doi: 10.1097/01.mlr.0000254567.79743.e2. PMID 17443114
- Cella D, Riley W, Stone A, Rothrock N, Reeve B, Yount S, Amtmann D, Bode R, Buysse D, Choi S, Cook K, Devellis R, DeWalt D, Fries JF, Gershon R, Hahn EA, Lai JS, Pilkonis P, Revicki D, Rose M, Weinfurt K, Hays R; PROMIS Cooperative Group. The Patient-Reported Outcomes Measurement Information System (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005- PMID 20685078
- Pfledderer CD, von Klinggraeff L, Burkart S, da Silva Bandeira A, Lubans DR, Jago R, Okely AD, van Sluijs EMF, Ioannidis JPA, Thrasher JF, Li X, Beets MW. Consolidated guidance for behavioral intervention pilot and feasibility studies. Pilot Feasibility Stud. 2024 Apr 6;10(1):57. doi: 10.1186/s40814-024-01485-5. PMID 38582840
- Pearson N, Naylor PJ, Ashe MC, Fernandez M, Yoong SL, Wolfenden L. Guidance for conducting feasibility and pilot studies for implementation trials. Pilot Feasibility Stud. 2020 Oct 31;6(1):167. doi: 10.1186/s40814-020-00634-w. PMID 33292770
Identifiers
NCT: NCT07102914 · 2000040244 · 1R34MH139716-01