About this trial
The ASSIST Study is designed to explore whether a brief, evidence based substance use screening and counseling approach can be easily integrated into routine survivorship care at St. Jude Children's Research Hospital.
During a regularly scheduled psychosocial visit, participants complete the World Health Organization's Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST). This short questionnaire helps identify patterns of use related to tobacco, alcohol, cannabis, prescription medications, and other substances. Survivors whose results show possible risk receive a brief, supportive counseling session during the same appointment. This session uses motivational interviewing techniques to help individuals reflect on their use and consider steps to reduce potential harm.
Primary Objective:
\- Assess the feasibility and acceptability of integrating a standardized substance use screening and brief intervention protocol into routine psychosocial workflows within a survivorship clinic.
Secondary Objective:
\- Evaluate the fidelity of delivering a brief substance use intervention to reduce substance use behaviors among survivors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Followed in the ACT Clinic at St. Jude Children's Research Hospital
Greater than or equal to 15 years of age at time of evaluation
Able to speak and read English
Disqualifiers
Significant mental or cognitive impairment that would impact ability to complete surveys or participate in the brief intervention
Trial design
Parallel
Treatments tested in this trial
WHO ASSIST v3.1 Screening with Feedback
BehavioralAn 8 item clinician administered instrument assessing lifetime and recent (past 3 months) use across substance classes (tobacco, alcohol, cannabis, cocaine, amphetamine type stimulants, sedatives/sleeping pills, hallucinogens, inhalants, opioids, and other drugs).Risk scores wiil be produced to guide intervention level. The assessment will be administered orally during a routine psychosocial visit by an LCSW. In the experimental arm, risk feedback will be shared using a scorecard
ASSIST Linked Brief Intervention (10 Step Motivational interviewing (MI)/FRAMES)
BehavioralFor participants screening moderate/high risk in the experimental arm, a same session, brief intervention consistent with motivational interviewing and FRAMES is delivered by an LCSW. Ten steps include: purpose of discussion, feedback on scores, information/advice, emphasize responsibility, express concern/support, explore "good things," explore "less good things," summarize, explore readiness/next steps with goal setting if ready, and provide self help materials. Sessions will be audio recorded for fidelity review.
WHO ASSIST v3.1 Screening (No Feedback)
BehavioralAn 8 item clinician administered instrument assessing lifetime and recent (past 3 months) use across substance classes (tobacco, alcohol, cannabis, cocaine, amphetamine type stimulants, sedatives/sleeping pills, hallucinogens, inhalants, opioids, and other drugs).Risk scores wiil be produced to guide intervention level. The assessment will be administered orally during a routine psychosocial visit by an LCSW. In the control arm, no scorecard/feedback will be provided.
Treatment groups
Trial outcomes
Primary outcomes
Enrollment Feasibility
Proportion of participants approached that enroll in the study
Screener Feasibility
Proportion of participants enrolled that completed the substance use screener with their social worker
Brief Intervention Feasibility
Proportion of participants that scored moderate-to-high risk on the substance use screener that received a brief intervention to reduce substance use
Care coordination Feasibility
Proportion of participants that received a referral for additional services received a coordination of care call from their social worker within 48 business hours of their social work visit
Secondary outcomes
Intervention Fidelity
Intervention fidelity will be evaluated through paneled audit of intervention session audio recordings by trained study fidelity coders who will assess adherence to the 10-step intervention protocol (Appendix V). Meeting fidelity thresholds will be defined as ≥80% protocol adherence. An abridged Motivational Interviewing Treatment Integrity Code (MITI 4) will also be used to assess adherence to key MI techniques used during delivery of the ASSIST linked brief intervention. Interrater reliability will be assessed by comparing percentages derived from the study-adapted MITI 4. Fidelity coders, who did not serve as interventionists, will be trained in all coding procedures. In addition to protocol adherence, behavior counts (e.g., information giving, eliciting change talk, reflections, affirmations, collaboration, autonomy support, and confrontation) will be summarized to characterize MI technique use. Fidelity will be monitored throughout the study and summarized at study completion.
Other outcomes
Care Coordination Preliminary Efficacy
Proportion of participants referred to care that enrolled in follow-up care
Substance Use Reduction Attempt
Proportion of participants that self-reported attempts to reduce substance use
Substance Use Reduction Amount
Average extent substance use was reduced
Substance Use Reduction Duration
Average number of days substance use was reduced
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