Theory-based Social Media Intervention for Non-medical Use of Prescription Opioids in Young Adults
Theory-based Social Media Intervention for Non-medical Use of Prescription Opioids in Young Adults
Sponsors
Source
University of South Carolina
Oversight Info
Has Dmc
No
Is Fda Regulated Drug
No
Is Fda Regulated Device
No
Is Us Export
No
Brief 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.
Detailed Description
Non-medical use of prescription opioids (NMUPO) is a timely and significant public health
issue in the United States (US). Young adults are the key population vulnerable to NMUPO.
Existing literature indicates that NMUPO in young adults is influenced by a robust array
of psychosocial factors. Tailored interventions guided by a psychosocial theory, such as
the information-motivation-behavioral skills (IMB) model, are urgently needed for
addressing NMUPO in young adults. One innovative approach is to reach out to and deliver
psychosocial interventions to young adults via social media technology, yet limited
efforts have sought to develop such interventions for NMUPO among young adults. Thus the
scientific objective of this study is to gather data via IMB-guided formative study
regarding psychosocial influences on NMPUO and then to use these findings to inform the
development of a peer-led social media intervention designed to reduce NMUPO among young
adults. The objective of this study is to obtain intensive mentored training essential to
improving the theoretical and practical expertise needed to develop innovative and
implementable peer-led psychosocial interventions for NMUPO in high-risk populations.
This study includes three specific research aims. In Aim 1, formative research, guided by
the IMB model, will be conducted to explore psychosocial contents associated with NMUPO
in young adults. The findings from Aim 1 will be inform the development of a peer-led
social media intervention to reduce NMUPO among young adults (Aim 2). The intervention
will integrate promising psychotherapy principles and incorporate with peer leaders who
are well-trained for recovery coaching. In Aim 3, the feasibility, acceptability,
usability, and preliminary efficacy on NMUPO reduction and psychosocial changes of the
theory-based social media intervention will be evaluated through a 12-week pilot
randomized controlled trial among 70 NMUPO engaging young adults (35 for intervention and
35 for control) via pre-test, 12-week ecological momentary assessment (during the
intervention), and post-tests (12-month follow-ups). This project will contribute to
future largescale and fully-powered psychosocial interventions for NMUPO among young
adults or other high-risk populations using innovative technology that can address
challenges in traditional substance use interventions.
Overall Status
Recruiting
Start Date
2024-05-01
Completion Date
2029-04-30
Primary Completion Date
2028-04-30
Phase
N/A
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
Engagement |
Once in every two days for 12 weeks |
|
Acceptability |
Once in every two days for 12 weeks |
|
Feasibility of the intervention |
Immediately at 12-week post-intervention |
|
Usability |
Once in every two days for 12 weeks |
|
Dose |
Once in every two days for 12 weeks |
|
Non-medical use of prescription opioids |
Immediately at pre-intervention and 12-week post-intervention |
Secondary Outcome
Measure |
Time Frame |
|
Outcome expectancies |
immediately at pre-intervention and 12-week post-intervention |
|
Risk perception |
immediately at pre-intervention and 12-week post-intervention |
|
Action self-efficacy and coping self-efficacy |
immediately at pre-intervention and 12-week post-intervention |
|
Depression |
immediately at pre-intervention and 12-week post-intervention |
|
Anxiety |
immediately at pre-intervention and 12-week post-intervention |
|
Resilience |
immediately at pre-intervention and 12-week post-intervention |
|
Other substance use |
immediately at pre-intervention and 12-week post-intervention |
|
Non-medical use of prescription opioids knowledge |
immediately at pre-intervention and 12-week post-intervention |
Enrollment
100
Conditions
Intervention
Intervention Type
Behavioral
Intervention Name
Description
A pilot randomized controlled trial of the 12-weeks social media intervention for
non-medical use of prescription opioids (NMUPO) among young adults will be developed upon
the formative research (Aim 1) grounded in the information-motivation-behavioral-skills
(IMB) model. Intervention will be delivered by peer leaders, who are well-trained
recovery coaches, via private groups on Instagram. Intervention contents will be tailored
to psychosocial factors contributing to NMUPO.
Intervention components. Incorporating Instagram functions, the intervention is planned
to include four intervention modules: (1) NMUPO knowledge module, (2) self-care module,
(3) virtual goal setting/monitoring module, (4) peer support module. Intervention will be
delivered by peer leaders (assisted by clinical psychology trainees a) via private groups
operated by their Instagram accounts. The process will be overseen by certificated
experts in clinical psychology and addiction treatment.
Arm Group Label
12-week peer-led intervention group on Instagram
Other Name
Information-motivation-behavioral skills model guided intervention
peer-led intervention
social media intervention
psychosocial intervention
Eligibility
Criteria
Inclusion Criteria:
- aged 18-25 years
- from the U.S.
- can read and speak English
- engage in non-medical use of prescription opioids in the past three months: taking
prescription opioids without a doctor's prescription/taking more doses of
prescription opioids than what a prescription allows/using prescription opioid for
reasons other than a medical purpose
- use Instagram three times a week or more in the past three months
Exclusion Criteria:
- receiving substance use interventions in the past three months
- are diagnosed with substance use disorders
- are not proficient in English
Gender
All
Minimum Age
18 Years
Maximum Age
25 Years
Healthy Volunteers
Accepts Healthy Volunteers
Overall Contact
Last Name
Cheuk Chi Tam, Ph.D.
Phone
803-777-6883
ctam@mailbox.sc.edu
Location
Facility |
Status |
Contact |
Investigator |
|
University of South Carolina Columbia South Carolina 29208 United States |
Recruiting |
Last Name: Cheuk Chi Tam, Ph.D. Phone: 803-777-6883 Email: ctam@mailbox.sc.edu |
Last Name: Cheuk Chi Tam, Ph.D. Role: Principal Investigator |
Location Countries
Country
United States
Verification Date
2024-06-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Principal Investigator
Investigator Affiliation
University of South Carolina
Investigator Full Name
Cheuk Chi Tam
Investigator Title
Research Assistant Professor
Keywords
Has Expanded Access
No
Condition Browse
Secondary Id
1K01DA058768-01A1
Number Of Arms
2
Arm Group
Arm Group Label
12-week peer-led intervention group on Instagram
Arm Group Type
Experimental
Description
Participants in the intervention group will receive 12-week peer-led intervention
interactive modules on Instagram.
Arm Group Label
Control group
Arm Group Type
No Intervention
Description
Participants in the control group will not engage in any intervention activities.
Firstreceived Results Date
N/A
Overall Contact Backup
Last Name
Xiaoming Li
Phone
803-777-8874
Patient Data
Sharing Ipd
No
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
The intervention will be a pilot trial, conducted through a Randomized controlled trial
design.
Primary Purpose
Prevention
Masking
None (Open Label)
Study First Submitted
June 11, 2024
Study First Submitted Qc
June 17, 2024
Study First Posted
June 24, 2024
Last Update Submitted
June 21, 2024
Last Update Submitted Qc
June 21, 2024
Last Update Posted
June 25, 2024
ClinicalTrials.gov processed this data on June 25, 2024
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.