Clinical trial NCT06115746: A Randomized Clinical Trial of a Novel Drug Education and Diversion Program (iDECIDE) for Middle and High School Students
Official title: A Randomized Clinical Trial of a Novel Drug Education and Diversion Program (iDECIDE) for Middle and High School Students
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Substance Use
Harm Reduction
Adolescent Behavior
Keywords: Adolescent
Diversion program
iDECIDE
Tier 2
School
Substance use prevention
Addiction
Early intervention
Targeted prevention
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Massachusetts Department of Health
First posted: 2023-11-03
Enrollment: 300
Sex: ALL
Minimum age (years): 9
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Approximately 300 participants will be enrolled into a two-arm, assessor-blind, randomized controlled trial to compare substance use outcomes (i.e., knowledge, behavior, and attitudes) across a one-year follow-up period in adolescents randomly assigned to the iDECIDE drug curriculum or the waitlist control group.
Primary purpose: PREVENTION

Brief summary: The primary goal of this study is to test the effectiveness of the iDECIDE (Drug Education Curriculum: Intervention, Diversion, and Empowerment) curriculum, a novel drug education and diversion program, in approximately 300 middle and high school students, who have violated their school substance use policies in the past month, as an alternative to punitive school responses for school-based substance use infractions. This randomized controlled trial will test the hypothesis that adolescents randomized to the iDECIDE curriculum will have improved substance use outcomes (i.e., knowledge, attitudes, and behavior) compared to adolescents in a waitlist control group. The outcomes of this study will measure knowledge of drug effects and brain development, perceptions of harm from substance use, willingness to quit or reduce use, and substance use behavior.

Detailed description: This study will be a two-arm, assessor-blind, randomized controlled trial enrolling approximately 300 middle and high school students who have recently violated a school substance use policy. Participants will be followed over a one-year period. Participants will be randomly assigned to either four-weeks of iDECIDE or a waitlist control group. Participants assigned to receive iDECIDE will receive a drug education curriculum developed to provide behavioral support and psychoeducation via videoconference or in-person visits. The purpose of iDECIDE is to provide students with the knowledge and skills they need to make healthy decisions regarding substance use. Participants in the waitlist control group will undergo symptom and substance use monitoring only, until completion of the one-month follow-up visit at which point they will be offered the opportunity to enroll in the iDECIDE curriculum, if desired. Data collection will occur during nine visits over the span of approximately one year, including one randomization baseline visit, four weekly visits during the intervention phase of the study during which time participants will participate in either iDECIDE or monitoring, and then four follow-up visits. The follow-up visits will occur at approximately one week, one month, six months, and one year following the end-of-intervention. Participants in both arms will complete questionnaires and assessments conducted by raters blinded to study arm assignment. Primary outcomes (knowledge of drug effects, knowledge of brain development and neurobiology of addiction, readiness to quit, perceptions of harm, and frequency of substance use) will be assessed at visit 1 (baseline), visit 5 (end-of-intervention), visit 6 (one week follow-up), and visit 7 (one month follow-up). Participants will be compensated for session attendance and provision of urine samples.

Eligibility criteria: Inclusion Criteria:

1. Currently enrolled in middle or high school;
2. Violated school substance use policy within approximately the past month at the time of screening;
3. Have a parent or legal guardian who is able and willing to provide written informed consent (if under the age of 18);
4. Competent and willing to provide written informed assent (if under the age of 18) or written informed consent (if age 18 or older);
5. Able to commit to 9 study visits over approximately one year;
6. Able to safely participate in the protocol and appropriate for outpatient level of care, in the opinion of the investigator;
7. Has access to a reliable internet connection and a device that can run Zoom;
8. Able to read and write comfortably in one of the languages spoken by study staff.

Exclusion Criteria:

1. Ever received substance use treatment in an inpatient or specialty care setting;
2. Gross cognitive impairment, for example due to florid psychosis, intellectual disability, developmental delay, or neurodegenerative disease;
3. Ever engaged in intravenous (IV) drug use;
4. Current daily use of alcohol, non-medical benzodiazepines, and/or opioid use.

Primary outcomes:
measure: Knowledge of Drug Effects and Brain Development
timeFrame: Baseline to 1-month follow-up (primary) and 1-year follow-up (exploratory)
measure: Frequency of Substance Use
timeFrame: Baseline to 1-month follow-up (primary) and 1-year follow-up (exploratory)
measure: Readiness to Quit or Reduce Substance Use
timeFrame: Baseline to 1-month follow-up (primary) and 1-year follow-up (exploratory)
measure: Perceived Harm of Substance Use
timeFrame: Baseline to 1-month follow-up (primary) and 1-year follow-up (exploratory)
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References:
citation: Liu J, Butler R, Turncliff A, Gray C, Lynch S, Whittaker J, Iroegbulem V, Howell D, Schuster RM. An Urgent Need for School-Based Diversion Programs for Adolescent Substance Use: A Statewide Survey of School Personnel. J Adolesc Health. 2023 Sep;73(3):428-436. doi: 10.1016/j.jadohealth.2023.04.006. Epub 2023 Jun 15.
citation: Schuster RM, Cather C, Pachas GN, Nielsen L, Iroegbulem V, Dufour J, Potter K, Levy S, Gray KM, Evins AE. A randomized controlled trial of varenicline and brief behavioral counseling delivered by lay counselors for adolescent vaping cessation: Study protocol. Front Psychiatry. 2023 Mar 15;14:1083791. doi: 10.3389/fpsyt.2023.1083791. eCollection 2023.