Clinical trial NCT04941950: A Digital Intervention to Prevent the Initiation of Opioid Misuse in Adolescents in School-based Health Centers
Official title: A Digital Intervention to Prevent the Initiation of Opioid Misuse in Adolescents in School-based Health Centers (Randomized Controlled Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Misuse
Lead sponsor: Trustees of Dartmouth College
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2021-06-28
Enrollment: 533
Sex: ALL
Minimum age (years): 16
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary hypothesis of this study is that at 3 months, there will be a higher proportion of intervention participants vs. control participants who report greater risk of harm from misuse of prescription opioids AND heroin.

Detailed description: This study's specific aims are to:

Conduct a randomized controlled trial with 532 high-risk adolescents in 10 School Based Health Centers (SBHCs), to compare PlaySmart to attention/time control games, with assessments post- gameplay (6 weeks), and at 3, 6, and 12 months following enrollment to determine if PlaySmart: 1) increases proportion of participants who report a perception of great risk of harm from misuse of opioids at 3 months; and 2) decreases intentions to misuse opioids; 3) increases self-efficacy for refusing opioids; 4) prevents initiation of opioid misuse, at all time-points.

Eligibility criteria: Inclusion Criteria:

* Participants must:
* 1) preferably be enrolled in their high school's School-Based Health Center;
* 2) report NOT having engaged in any prior opioid misuse;
* 3) be at "high-risk" based on their report at baseline of past 30-day use of cigarettes, e-cigarettes, Juul, alcohol, marijuana (including synthetics), amphetamine, cocaine, benzodiazepines, ecstasy, bath salts, or any other misuse of non-opioid prescription drugs or use of non-opioid illicit drugs OR have a score of ≥1 on the PHQ-2 OR a score of ≥1 on the GAD-2 (both screening tools used by SBHA);
* 4) be willing to sit for 60 minutes/session to play the game;
* 5) be able to provide assent/parental/guardian consent (if under age 18).

Exclusion Criteria:

* Failure to meet any of the inclusion criteria.

Primary outcomes:
measure: Perception of Risk
timeFrame: 3 months
measure: Change in Perception of Risk
timeFrame: Baseline, 6 weeks, 3, 6, and 12 months
Secondary outcomes:
measure: Change in Intentions to Misuse Opioids (p2P Lab Questions)
timeFrame: Baseline, 6 weeks, 3, 6, and 12 months
measure: Change in Self Efficacy for Refusing Opioids (p2P Lab Questions)
timeFrame: Baseline, 6 weeks, 3, 6, and 12 months
measure: Change in Prevention of Initiation of Opioid Misuse (p2P Lab Questions)
timeFrame: Baseline, 6 weeks, 3, 6, and 12 months
measure: Change in Knowledge about opioid misuse and its risks and mental health (p2P Lab Questions)
timeFrame: Baseline, 6 weeks, 3, 6, and 12 months
measure: Change in Attitudes to Misuse Opioids (p2P Lab Questions)
timeFrame: Baseline, 6 weeks, 3, 6, and 12 months
measure: Change in Perceived Norms About Opioid Misuse (p2P Lab Questions)
timeFrame: Baseline, 6 weeks, 3, 6, and 12 months
measure: Decision-Making Skills (p2P Lab Questions)
timeFrame: Baseline, 6 weeks, 3, 6, and 12 months
measure: Self-Regulation (Across Time-TRAIT DERS) (p2P Lab Questions)
timeFrame: Baseline
measure: Self-Regulation (In a specific moment-STATE DERS) (p2P Lab Questions)
timeFrame: Baseline, 6 weeks, 3, 6, and 12 months
measure: Help-Seeking Behavior (Past) (p2P Lab Questions)
timeFrame: Baseline, 6 weeks, 3, 6, and 12 months
measure: Help Seeking Behavior (General) (p2P Lab Questions)
timeFrame: Baseline, 6 weeks, 3, 6, and 12 months
measure: Self-Stigma of Seeking Help Scale (p2P Lab Questions)
timeFrame: Baseline, 6 weeks, 3, 6, and 12 months
measure: Beliefs About Psychological Services (p2P Lab Questions)
timeFrame: Baseline, 6 weeks, 3, 6, and 12 months
measure: Gameplay Experience (p2P Lab Questions)
timeFrame: 6 weeks
measure: Gameplay Usability (p2P Lab Questions)
timeFrame: 6 weeks
measure: Gameplay Engagement (p2P Lab Questions)
timeFrame: 6 weeks
measure: Involvement with Legally Manufactured Opioids (Coordinating Center Questions)
timeFrame: Baseline, 6 weeks, 3, 6, and 12 months
measure: Involvement with Illegally Manufactured Opioids (Coordinating Center Questions)
timeFrame: Baseline, 6 weeks, 3, 6, and 12 months
measure: Involvement with Alcohol (Coordinating Center Questions)
timeFrame: Baseline, 6 weeks, 3, 6, and 12 months
measure: Involvement with Marijuana (Coordinating Center Questions)
timeFrame: Baseline, 6 weeks, 3, 6, and 12 months
measure: Self-Efficacy (Coordinating Center Questions)
timeFrame: Baseline, 6 weeks, 3, 6, and 12 months
measure: Mental Health (Depression - PHQ-8) (Coordinating Center Questions)
timeFrame: Baseline, 6 weeks, 3, 6, and 12 months
measure: Mental Health (Anxiety - GAD-7) (Coordinating Center Questions)
timeFrame: Baseline, 6 weeks, 3, 6, and 12 months
measure: Experience with Pain (Coordinating Center Questions)
timeFrame: Baseline, 6 weeks, 3, 6, and 12 months
measure: Social Exposure to Substance Misuse (Exposure to Drugs and Alcohol) (Coordinating Center Questions)
timeFrame: Baseline, 6 weeks, 3, 6, and 12 months
Other outcomes:
Locations:
city: Bridgeport
country: United States
facility: Harding High School
state: Connecticut
city: Durham
country: United States
facility: Coginchaug High School
state: Connecticut
city: East Hartford
country: United States
facility: CT River Academy
state: Connecticut
city: Fairfield
country: United States
facility: Fairfield College Preparatory School
state: Connecticut
city: Groton
country: United States
facility: Fitch High School
state: Connecticut
city: Hamden
country: United States
facility: Hamden High School
state: Connecticut
city: Hartford
country: United States
facility: Weaver High School
state: Connecticut
city: Meriden
country: United States
facility: Maloney High School
state: Connecticut
city: Meriden
country: United States
facility: Platt High School
state: Connecticut
city: New Haven
country: United States
facility: Hopkins High School
state: Connecticut
city: New London
country: United States
facility: New London High School
state: Connecticut
city: Stamford
country: United States
facility: Stamford High School
state: Connecticut
city: Stamford
country: United States
facility: Westhill High School
state: Connecticut
city: Stamford
country: United States
facility: Academy of Information, Technology, and Engineering
state: Connecticut
city: West Haven
country: United States
facility: West Haven High School
state: Connecticut
Study officials:
affiliation: Director, play2PREVENT Lab & Professor, BDS at Geisel School of Medicine at Dartmouth College
name: Lynn E Fiellin, MD
role: PRINCIPAL_INVESTIGATOR
References: