Theory-based Social Media Intervention for Non-medical Use of Prescription Opioids in Young Adults
NCT Number: NCT06469749
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Young Adults|Past-3-month Non-medical Use of Prescription Opioids|Without Substance Use Disorders|Social Media Users
Interventions: BEHAVIORAL: Theory-based and peer-led intervention on Instagram
Sponsor: University of South Carolina
Collaborators: National Institute on Drug Abuse (NIDA)
Sex: ALL
Age: ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-05-01
Completion Date: 2029-04-30
Locations: University of South Carolina, Columbia, South Carolina, 29208, United States

Summary:
Brief Summary

The purposes of this study are to develop and implement a peer-led intervention program on Instagram for promoting prescription opioid use management and fostering psychosocial skills among young adults who engage in non-medical use of prescription opioids in the United State. The specific aims of the study include:

1. To conduct formative interviews to identify psychosocial determinants/skills and relevant vivid examples associated with non-medical use of prescription opioids
2. To develop peer-led modules in accordance with Aim (1) and health behavior theories on Instagram
3. To implement and test the feasibility of the 12-week peer-led intervention modules on Instagram among young adults who are randomly assigned to either receive the intervention (intervention group) or not receive the intervention (control group)

In Aim (1), participants will be invited to online audio-recorded 60-minute individual interviews with the research team on topics regarding personal experiences in using prescription opioids and psychosocial skills or factors relevant to them.

In Aim (3), participants who are assigned to the intervention group will be paired with a peer leader and attend to peer-guided interactive modules on Instagram over 12 weeks. They will complete an online survey at 1st week and 12th week, as well as brief evening surveys every two days during the intervention. The control group will not take part in intervention activities but will complete an online survey at 1st week and 12th week.

Primary Outcome Measures: Engagement, Paradata (e.g., frequencies of shares, comments, likes, and posts) on particular intervention contents), Once in every two days for 12 weeks|Acceptability, Likert items that rate how helpful the particular intervention module is (1 = not at all to 5 = extremely). This will be measured in the ecological momentary assessment surveys., Once in every two days for 12 weeks|Feasibility of the intervention, Feasibility will be assessed via the post-intervention interviews in terms of the reactions to the contents, format, concepts, and visual presentation of modules., Immediately at 12-week post-intervention|Usability, Usability will be measured using the Usefulness, Satisfaction, and Ease of use-Lite (USE-Lite) questionnaire which assesses perceived usefulness and satisfaction for specific intervention modules. This will be measured in the ecological momentary assessment surveys. The scale comprises a total of 15 items, with 8 items for usefulness and 7 for satisfaction. Items are rated on a 7-point scale (1=strong disagree to 7=strong agree). The sum score for each component will be generated, with a higher score indicating a greater level of usefulness (ranging from 8 to 56) or satisfaction (ranging from 7 to 49)., Once in every two days for 12 weeks|Dose, Guided by dose operationalization for mHealth intervention, dose of intervention will be collected in three domains: (1)intervention actions (if viewing a post); (2) participant actions (if practicing a skill/completing an assignment); (3) behavioral target actions (if adopting skills outside of the intervention). This will be measured in the ecological momentary assessment surveys., Once in every two days for 12 weeks|Non-medical use of prescription opioids, Any behaviors to indicate (1) taking a prescription opioid without a prescription; (2) taking prescription opioids more doses than what a prescription allows; (3) using prescription opioids for reasons other than a medical purpose. The frequency of such behaviors in the past 30 days will be assessed using the Tobacco, Alcohol, Prescription medication, and other Substance use Tool (TAPS) tool., Immediately at pre-intervention and 12-week post-intervention
Secondary Outcome Measures: Outcome expectancies, Beliefs on positive or negative consequences of engaging in non-medical use of prescription opioids. This will be assessed using a scale adapted from the Behaviors, Expectancies, Attitudes and College Health Questionnaire (BEACH-Q). A total of 50 Items will be scored on a five-point Likert-type scale ranging from 0 (Not at all) to 4 (Very often or always) with higher sum scores standing for the greater level of expectancies. The sum scores range from 0 to 200. The scale consists of eight dimensions related to specific expectancies of opioids, including pain reduction, tension reduction, academic preference, emotion enhancement, social enhancement, guilt and dependence, cognitive impairment, and physical discomfort., immediately at pre-intervention and 12-week post-intervention|Risk perception, Perceived vulnerability and severity of engaging in non-medical use of prescription opioids. This will be assessed using the Perceived Risk Scale for Prescription Drug Abuse. This scale includes 5 items on a four-option scale (1="strongly disagree" to 4 = "strongly agree". The sum score will be generated (range = 5 to 20), with higher score indicating a greater level of perception risk for non-medical use of prescription opioids., immediately at pre-intervention and 12-week post-intervention|Action self-efficacy and coping self-efficacy, Perceived control on making actions to stop/reduce NMUPO or confidence on coping with barriers against the actions. This will be assessed using an adapted version of Self-Efficacy Scale. A total of six Items will be rated on a 5-point Likert scale (1 = strong disagree, 5 = strongly agree) and can be organized into 2 subscales (coping self-efficacy and action self-efficacy) with 3 items each. The maximum obtainable score for each subscale will be 15 points, and the minimum obtainable score is 3 points. The sum scores will be generated for each subscale, with higher scores indicating greater levels of self-efficacy., immediately at pre-intervention and 12-week post-intervention|Depression, Experiences of depressive symptoms in the past two weeks. This will be assessed using the Patient Health Questionnaire-9 (PHQ-9). Nine items will be rated on a 4-option scale (0 = not at all, 3 = nearly every day) with a minimum possible score of 0 and a maximum score of 27. The sum score will be generated, with a higher score indicating a higher level of depression., immediately at pre-intervention and 12-week post-intervention|Anxiety, Anxious symptom experiences in the past two weeks. This will be assessed using the General Anxiety Disorder-7 (GAD 7). Seven items will be rated on a 4-option scale (0 = not at all, 3 = nearly every day) with a minimum possible score of 0 and a maximum score of 21. The sum score will be generated, with a higher score indicating a higher level of anxiety., immediately at pre-intervention and 12-week post-intervention|Resilience, Personal capacities in response to stress such as tenacity, tolerance of negative affect, positive acceptance of change, and positive view of adversities. This will be assessed using the Connor-Davidson resilience scale (CD-RISD). The scale comprises of 25 items, with each rated on a 5-point scale (0 to 4). The sum score will be generated, with a higher score indicating a greater level of resilience. The possible sum score ranges from 0 to 100., immediately at pre-intervention and 12-week post-intervention|Other substance use, Engagement in the use of alcohol, illicit drugs, and cigarette in the past three months. This will be assessed using the NIDA-Modified Alcohol, Smoking and Substance Involvement Screening (NIDA-ASSIST). The scale includes 12 dichotomous items (0= No, 1 = Yes) asking if a participant has engaged in using or misusing any of 12 individual substances., immediately at pre-intervention and 12-week post-intervention|Non-medical use of prescription opioids knowledge, Information about non-medical use of prescription opioids and relevant topics, such as misconceptions, the role of fentanyl, naloxone, and Xyalazine. This scale will be developed according to the measure in POP4Teens and the formative study. This scale is proposed to include 15 statements related to opioids or non-medical use of prescription opioids. Participant will be asked to determine if a statement is true or not (0 = False, 1 = True). Responses will then be rated by the research team, with higher scores indicating better knowledge of non-medical use of prescription opioids., immediately at pre-intervention and 12-week post-intervention