Pain, Postoperative, Substance Use
Conditions
Brief summary
This is a clinical trial that will evaluate the feasibility and acceptability of a virtual brief program for adolescents and young adults undergoing wisdom tooth extraction and their parents. The program aims to teach youth safe and effective ways to manage post-surgical pain as well as decrease risky health behaviors.
Interventions
BEHAVIORALiPAWS
The brief intervention (named iPAWS) will be an integration of evidence-based brief interventions for AYA SU (e.g. MET-CBT) and acute pain coping (CBT). The intervention is brief, readily accessible, developmentally tailored, applicable to single and poly-SU and scalable to other acutely painful procedures to meet the need for effective, accessible, and scalable SU interventions at key entry points of clinical care.
OTHEREducational Materials
Participants will be given a digital copy of a brochure from the American Dental Association on "Wisdom Teeth Management" (included in attachments). The investigator will also mail the participant a hard copy of the brochure, if requested.
Sponsors
Brown University
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
15 Years to 20 Years
Healthy volunteers
Yes
Inclusion criteria
* Ages 15 to 20 years * Undergoing wisdom tooth extraction for the first time * Able to read simple English * \*Endorse cannabis use at least two days per week on average in the past 28 days \*The investigator aims to recruit at least 50 participants who are using cannabis at least two days per week in the past 28 days on average and will recruit up to 100 additional participants who use other substances, use cannabis at a lesser intensity, or do not use any substances. * (Parent/Guardian only) - Have a child who is undergoing wisdom tooth surgery and is participating in the study
Exclusion criteria
\- N/A
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who complete the active treatment phase (feasibility) | End of active treatment phase (6 weeks) | The number of participants who complete the active treatment phase will determine feasibility. The treatment will be considered feasible if the number of participants who complete treatment is ≥ 70%. |
| Number of participants who rate their treatment experience in the "satisfactory" or "highly satisfactory" range on the Client Satisfaction Questionnaire (Acceptability) | End of active treatment phase (6 weeks) | The Client Satisfaction Questionnaire (CSQ-8) which ranges in scores from 8 to 32 will determine acceptability. Higher scores indicate higher satisfaction (i.e. better outcomes). Treatment will be considered acceptable if the number and percentage of participants who rate their experience either "satisfactory" or "highly satisfactory is ≥ 80%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of cannabis use days | Last 3 weeks of active treatment phase (weeks 4-6) | Number of days that participants consumed cannabis over the last 3 weeks (weeks 4-6 of treatment) will be measured by the Timeline Followback Interview. |
| Pain intensity | Last 3 weeks of active treatment phase (weeks 4-6) | Average pain intensity is assessed during daily Ecological Momentary Assessments using the Numerical Rating Scale (NRS) . This is assessed on a scale from 0 (no pain) to 10 (most pain possible). Minimum value= 0 and maximum value=10. Higher scores indicate higher levels of pain (i.e. worse outcome). Analysis will examine average pain levels after treatment (weeks 4-6). |
| Substance use craving | Last 3 weeks of active treatment phase (weeks 4-6) | Substance use craving is measured during daily Ecological Momentary Assessments using an item validated in past work: "How strong is your urge to use substances right now? This includes marijuana, alcohol, nicotine, and other drugs." This is assessed on scale from 0 (no urge) to 10 (strongest urge ever). Minimum value= 0 and maximum value=10 and higher scores indicate higher levels of craving (i.e. worse outcomes). Analysis will examine responses to this item after treatment (weeks 4-6). |
| Abstinent days | Last 3 weeks of active treatment phase (weeks 4-6) | Abstinent days (proportion of days on which no cannabis use is reported) during the last 3 weeks (treatment weeks 4-6). The analysis will control for baseline (defined as proportion of abstinent days in the two weeks preceding the treatment). |
| Pain intereference | Last 3 weeks of active treatment phase (weeks 4-6) | Pain interference is assessed during daily Ecological Momentary Assessments using 1 item: "How much is physical pain getting in the way of doing regular daily activities right now, including eating and drinking?" This is assessed on a scale from 0 (not at all ) to 10 (extremely). Minimum value= 0 and maximum value=10. Higher scores indicate higher levels of pain interference (i.e. worse outcome). Analysis will examine ratings of pain interference after treatment (weeks 4-6). |
| Pain coping strategies | Last 3 weeks of active treatment phase (weeks 4-6) | Utilization of non-pharmacological pain coping skills is assessed during daily Ecological Momentary Assessments using a checklist of psychosocial (n=10 items) and physical coping strategies (n=10 items). Responses are binary (yes or no). The minimum value for each type of skill is 0 and the maximum value is 10. Higher scores reflect higher utilization of these skills (i.e. better outcomes). Analysis will examine utilization of non-pharmacological pain coping skills after treatment (weeks 4-6) |
Countries
United States
Contacts
CONTACTMelissa Pielech, PhD
CONTACTKristin Rogers, MS
Outcome results
None listed