Recruiting

Substance Use Intervention

Sponsor:

St. Jude Children's Research Hospital

Code:

NCT07516301

Conditions

Survivors of Childhood Cancer

Substance Use

Eligibility Criteria

Sex: All

Age: 15+

Healthy Volunteers: Not accepted

Interventions

WHO ASSIST v3.1 Screening with Feedback

ASSIST Linked Brief Intervention (10 Step Motivational interviewing (MI)/FRAMES)

WHO ASSIST v3.1 Screening (No Feedback)

Study Details

Brief summary:

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.

Conditions

Survivors of Childhood Cancer

Substance Use

Study ID

NCT07516301

Start date

Oct, 2026

Status verified date

Sep, 2026

Completion date

Oct, 2028

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 15+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Significant mental or cognitive impairment that would impact ability to complete surveys or participate in the brief intervention

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: ASSIST Screening with Feedback and Brief Intervention

This arm is designed to integrate meaningful, patient centered conversations about substance use directly into routine survivorship care, making it easier for survivors to receive tailored support in real time

active comparator: ASSIST Screening Without Feedback

This comparison group will allow researchers to understand how the screening plus intervention approach differs from standard survivorship care, helping determine whether the added feedback and brief counseling are practical, acceptable, and potentially beneficial for adult survivors of childhood cancer.

Interventions

WHO ASSIST v3.1 Screening with Feedback

An 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)

For 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)

An 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.

Primary outcome measure

  • Enrollment Feasibility [ Time Frame: Through study completion, an average of 1 year ]
  • Screener Feasibility [ Time Frame: Through study completion, an average of 1 year ]
  • Brief Intervention Feasibility [ Time Frame: Through study completion, an average of 1 year ]
  • Care coordination Feasibility [ Time Frame: Through study completion, an average of 1 year ]
  • Screener Acceptability- Acceptability of Intervention Measure [ Time Frame: Time 1 (1-week post baseline assessment) ]
  • Intervention Acceptability - Acceptability of Intervention Measure [ Time Frame: Time 2 (3 months post baseline assessment) ]

Central Contacts and Locations

Central contacts

Rachel Webster, PhD

888-226-4343referralinfo@stjude.org

Locations

St. Jude Children's Research Hospital

Recruiting

Memphis, Tennessee, United States, 38105

Contacts

Rachel Webster, PhD

888-226-4343referralinfo@stjude.org

More Information

Sponsor

St. Jude Children's Research Hospital

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Keywords

  • Adult childhood cancer survivors (ACCS)
  • Cancer Survivorship

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Jude Children's Research Hospital on 2026-09-03.