Alcohol Use, UnderageNCT04160754
Mindfulness for at Risk Youth: Understanding Substance Use and Important Mechanisms of Change
A study testing Mindfulness Based Relapse Prevention in people with Alcohol Use, Underage and Alcohol Problem Drinking, run by University of Southern California at 1 site in United States.
Trial summary
This study will be the first to explore mindfulness as a prevention intervention among transition age youth and those with previous involvement in the juvenile or criminal justice system with substance use problems and history of exposure to violence/trauma. Read more about this study
- Who is it for?
- Ages 18 to 26 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use, Underage, Alcohol Problem Drinking, Substance Use
- What is being tested?
- Mindfulness Based Relapse Prevention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2019to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 26 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 to 26 years old at baseline
- English speaking
- Be willing to provide follow-up information
- Report past-month use of alcohol or drugs
- Score 2 or higher on the PC-PTSD scale
- Not currently receiving substance abuse treatment elsewhere
- Not prisoners
Who cannot join
- Does not speak English
- Receiving treatment from some other facility for substance use.
- Active psychosis symptoms
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Southern California, School of Social Work
Los Angeles, California, 90089
About this study
This study will be the first to explore mindfulness as a prevention intervention among transition age youth and those with previous involvement in the juvenile or criminal justice system with substance use problems and history of exposure to violence/trauma. The study will focus on preventing escalation of substance use (e.g., alcohol and marijuana), trauma symptoms, and recidivism by using an intervention to target self-regulation and executive functioning.
Justice involved youth have higher rates of alcohol use and related consequences and higher rates of exposure to violence (Post Traumatic Stress Disorder) compared to their non-justice involved peers. Prior research has found aspects of self-regulation (emotion regulation, impulse control), stress, and craving to be important putative targets in reducing alcohol use. With high rates of recidivism and increased risk of long term problems associated with substance use, it is imperative to test interventions that can reach at risk youth and target both alcohol use and important psychological and neurocognitive self-regulation mechanisms.
Read more
This study tests whether the use of Mindfulness-Based Relapse Prevention (MBRP) for at risk young adults results in changes in important self-regulation mechanisms and improved alcohol use outcomes. Individuals assigned to the experimental group will receive interventions normally provided at a community clinic and eight 1.5-hour group sessions of MBRP. Sessions will occur once per week. Each session will target a specific theme such as being aware of personal triggers, maintaining present focus, allowing or letting things be, responding to emotional and physical experiences in skillful ways, and recognizing intrusive thoughts. Further, each session will incorporate a mindfulness meditation technique.
The central hypothesis will be tested through a focus on three specific aims: (1) Beta pilot testing and refining MBRP based on feedback from focus groups, (2) testing the efficacy of MBRP on substance use outcomes compared to an active control, and (3) assessing mechanisms of change for MBRP including self-regulation and neurocognitive facets such as working memory and inhibition.
Read the detailed description
The long-term goal of this proposal is to improve alcohol use outcomes by targeting emotion regulation (ER), impulsivity (IMP), and executive functioning (EF) constructs among racially and ethnically diverse (primarily Hispanic and Black) at risk young adults. With a similar population, the investigators pilot tested a novel Mindfulness-Based Intervention (MBI), Mindfulness-Based Substance Abuse Treatment for Adolescents (MBRP) with with marginalized young adults. Findings from adolescent samples have found support for the intervention's effect on problem behaviors, decision making, and self-esteem. However, extent research in this area has not assessed substance use or self-regulation. In a sample of marginalized young adults receiving treatment at a residential treatment facility, MBRP was found to significantly decrease stress and substance use outcomes. In addition, only one study has investigated the effect of a MBI on neurocognitive functioning with justice-involved youth. Unfortunately, this was not a clinical intervention and did not assess EF as a mechanism of change. The current study proposes to recruit 70-80 young adults (aged 18-26) referred to one clinic in Los Angeles, CA. The study site has a wide range of referral sources ranging from self-referral to referrals from the justice system.
Some young adults are referred to treatment by schools in lieu of engaging law enforcement or in lieu of expulsion, with many being self-referred.
Participants will be randomly assigned to receive MBRP or attention control (CTL). Participants will engage in both self-report and task-based ER, IMP, and EF measures pre- and post-intervention. Participants will be followed for 3 months post-intervention to assess effects on alcohol use and behavioral health outcomes, and putative mechanisms of change.
The central hypothesis is that MBRP, compared to CTL, will prompt change in ER, IMP, and EF. Further, it is hypothesized that these changes will be associated with better alcohol use outcomes 3 months post-intervention. The rationale for using a MBI with marginalized youth is that prior research has shown significantly worse self-regulation compared to community youth, and MBRP is specifically designed to aid in regulating emotions, decision making, and attention control. The unique strengths of this proposal are its use of an MBI; focus on a disadvantaged population of diverse racial and ethnic groups; focus on putative targets essential to behavioral health outcomes; and use of multiple neurocognitive tasks addressing important self-regulation components. The study objective is to test following three aims:
Specific Aim 1: Determine feasibility and acceptability of abbreviated MBRP. An adapted MBRP protocol will be beta-tested with 15 transition age youth/young adults. Focus groups will be conducted to evaluate the feasibility and acceptability of an intervention focused on enhancing self-regulation, refine content based on feedback, and addressing issues that might affect the successful completion of pilot testing in Aim 2.
Specific Aim 2: Pilot test MBRP intervention on putative targets by randomly assigning young adults who screen for past-month alcohol use/problems to MBRP or CTL. Determine the effect of the program on secondary outcomes of interest and putative targets for ER, IMP, and EF.
Specific Aim 3: Assess MBRP mechanisms by exploring whether effects of the intervention on our substance use outcomes can be partially explained by changes in target mechanisms: ER, IMP, and EF.
- Being tested
- Mindfulness Based Relapse Prevention, Control (CTL)
- Keywords
- Trauma, Delinquency, Substance Use, Emotion Regulation, Impulsivity, Executive Functioning
- Medical subject headings
- Underage Drinking, Alcoholism, Substance-Related Disorders, Wounds and Injuries, Emotional Regulation, Impulsive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Based Relapse PreventionBehavioural
Individuals assigned to the experimental group will receive interventions normally provided at the clinic and eight 1.5-hour group sessions of MBRP. Each sessions will occur once per week and will target a specific theme such as being aware of personal triggers, maintaining present focus, allowing or letting things be, responding to emotional and physical experiences in skillful ways, and recognizing intrusive thoughts. Each session will incorporate a mindfulness meditation technique (e.g.,SOBER breathing space and "urge surfing"). Participants will receive materials (e.g., recordings) with which to perform practices and meditation during the intervention phase.
Control (CTL)Behavioural
Individuals assigned to the CTL group will receive interventions provided at the clinic and up to eight CTL sessions. The CTL group will receive information (reading) and videos once per week on health behaviors (e.g., exercise, eating) and the neurobiology of addiction. This approach will reduce the possibility that intervention effects are solely due to the experimental group's receiving extra attention. In contrast to the active intervention, sessions will be educational in nature, with no motivational, cognitive, or behavioral components
| Study group | Role | What they receive |
|---|---|---|
| MBRP | Experimental | The experimental group will receive treatment as usual plus eight Mindfulness based relapse prevention (MBRP) therapy sessions. Receives: Behavioral: Mindfulness Based Relapse Prevention |
| Control (CTL) | Active comparator | The CTL group will receive treatment as usual plus information on the neurobiology of addiction and healthy behaviors. Receives: Behavioral: Control (CTL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Substance Use
Substance use will be measured using time line follow back approach for 15 different substances. We will ask about days of use and number of times used for each substance in the past month
Measured: Baseline, 1 month, 2 months, 3 months, 4 months, 5 months
Change in PTSD symptoms
Initial screening of PTSD symptoms will be assessed by the Primary Care PTSD Screen for DSM-5 (PC-PTSD-5). We will further assess PTSD symptoms using the PTSD Checklist for DSM-5 (PCL-5). The PCL-5 is a 20-item self-report measure that assesses the 20 Diagnostic and Statistical Manual of Mental Disorders (DSM-5) symptoms of PTSD.
Measured: Baseline, 1 month, 2 months, 3 months, 4 months, 5 months
Change in Depression
Depression will be measured with the Center for Epidemiologic Studies Depression Scale (CES-D). The CES-D includes 20 items instructing participants how often they have experienced a variety of symptoms in the past week, ranging from "rarely or none of the time" to "Most or all of the time." The scoring of positive items is reversed. Possible range of scores is zero to 60, with the higher scores indicating the presence of more symptomology.
Measured: Baseline, 1 month, 2 months, 3 months, 4 months, 5 months
Secondary outcomes (6)
Executive Functioning
Executive functioning will be assessed using the Sustained Attention to Response Task (SART). The SART is a computer-based go/no-go task that requires participants to withhold behavioral response to a single, infrequent target (often the digit 3) presented amongst a background of frequent non-targets (0-2, 4-9).
Measured: Baseline, 2 months post-baseline
Emotion Regulation
Emotion regulation will be assessed using the short-form Difficulties in Emotion Regulation Scale (DERS-18). The DERS-18 asks participants to indicate how often they respond to their emotions in a variety of ways. Response options range on a 5-point scale from 1 (almost never, 0-10%) to 5 (Almost always, 91-100%). To obtain a total score, three items are reverse-scored and responses are summed. Total scores range from 18 to 90. Higher scores indicate greater difficulty regulating emotions.
Measured: Baseline, 1 month, 2 months, 3 months, 4 months, 5 months
Impulsivity
The SUPPS-P measures five components: Lack of premeditation, lack of perseverance, negative urgency, positive urgency, sensation seeking.
Measured: Baseline, 1 month, 2 months, 3 months, 4 months, 5 months
Delinquency
Delinquency will be assessed by self-reported offending.
Measured: Baseline, 1 month, 2 months, 3 months, 4 months, 5 months
Stress
Stress will be assessed using the Perceived Stress Scale (PSS). The PSS is the most widely used psychological instrument for measuring the perception of stress. It is a measure of the degree to which situations in one's life are appraised as stressful. The PSS consists of 10 items assessing perceived stress related to a variety of circumstances, with response options for each item existing on a 5-point scale ranging from 0 (never) to 4 (very often). Total PSS scores are obtained by reversing responses to the four positively stated items (items 4, 5, 7, \& 8) and then summing across all scale items (range: 0 to 40). Higher PSS scores reflect higher levels of perceived stress.
Measured: Baseline, 1 month, 2 months, 3 months, 4 months, 5 months
Violence Perpetration
Violence perpetration will be assessed using the Illinois Bullying Scale. Point values are assigned to each response as follows: Never = 0, 1 or 2 times = 1, 3 or 4 times = 2, 5 or 6 times = 3, 7 or more times = 4. Summary scores for each subscale can be obtained by adding the responses for associated items:
- Bully subscale: Items 1, 2, 8, 9, 14, 15, 16, 17, and 18
- Victim subscale: Items 4, 5, 6, and 7
- Fighting subscale: Items 3, 10, 11, 12, and 13
The Bully subscale score ranges from 0-36; the Victim subscale score ranges from 0-16; and the Fighting subscale score ranges from 0-20). Higher scores reflect higher levels of bullying, victimization, or fighting.
Measured: Baseline, 1 month, 2 months, 3 months, 4 months, 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2019
- Study start5 Mar 2019
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use, UnderageStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jordan Davis, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04160754
- Sponsor's protocol ID
- up-18-00230
- Status last verified
- Sep 2021
- First submitted
- 3 Oct 2018
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bechara A, Damasio AR, Damasio H, Anderson SW. Insensitivity to future consequences following damage to human prefrontal cortex. Cognition. 1994 Apr-Jun;50(1-3):7-15. doi: 10.1016/0010-0277(94)90018-3.
PubMed 8039375Cyders MA, Littlefield AK, Coffey S, Karyadi KA. Examination of a short English version of the UPPS-P Impulsive Behavior Scale. Addict Behav. 2014 Sep;39(9):1372-6. doi: 10.1016/j.addbeh.2014.02.013. Epub 2014 Mar 3.
PubMed 24636739Davis JP, Berry D, Dumas TM, Ritter E, Smith DC, Menard C, Roberts BW. Substance use outcomes for mindfulness based relapse prevention are partially mediated by reductions in stress: Results from a randomized trial. J Subst Abuse Treat. 2018 Aug;91:37-48. doi: 10.1016/j.jsat.2018.05.002. Epub 2018 May 20.
PubMed 29910013Espelage, D. L., & Holt, M. K. (2001). Bullying and victimization during early adolescence: Peer influences and psychosocial correlates. Journal of Emotional Abuse, 2(2-3), 123-142. https://doi.org/10.1300/J135v02n02_08
Hallion LS, Steinman SA, Tolin DF, Diefenbach GJ. Psychometric Properties of the Difficulties in Emotion Regulation Scale (DERS) and Its Short Forms in Adults With Emotional Disorders. Front Psychol. 2018 Apr 19;9:539. doi: 10.3389/fpsyg.2018.00539. eCollection 2018.
PubMed 29725312Himelstein, S. (2011). Mindfulness-Based Substance Abuse Treatment for Incarcerated Youth: A Mixed Method Pilot Study. International Journal of Transpersonal Studies, 1-10.
Himelstein, Sam, Hastings, A., Shapiro, S., & Heery, M. (2012). Mindfulness training for self-regulation and stress with incarcerated youth. Probation Journal, 59(2), 151-165. https://doi.org/10.1177/0264550512438256
Himelstein S, Saul S, Garcia-Romeu A, Pinedo D. Mindfulness training as an intervention for substance user incarcerated adolescents: a pilot grounded theory study. Subst Use Misuse. 2014 Apr;49(5):560-70. doi: 10.3109/10826084.2013.852580.
PubMed 24611851Jackson JD, Balota DA. Mind-wandering in younger and older adults: converging evidence from the Sustained Attention to Response Task and reading for comprehension. Psychol Aging. 2012 Mar;27(1):106-119. doi: 10.1037/a0023933. Epub 2011 Jun 27.
PubMed 21707183Leonard NR, Jha AP, Casarjian B, Goolsarran M, Garcia C, Cleland CM, Gwadz MV, Massey Z. Mindfulness training improves attentional task performance in incarcerated youth: a group randomized controlled intervention trial. Front Psychol. 2013 Nov 8;4:792. doi: 10.3389/fpsyg.2013.00792. eCollection 2013.
PubMed 24265621Prins, A., Bovin, M. J., Kimerling, R., Kaloupek, D. G., Marx, B. P., Pless Kaiser, A., & Schnurr, P. P. (2015). The Primary Care PTSD Screen for DSM-5 (PC-PTSD-5) [Measurement Instrument]. Retrieved from https://www.ptsd.va.gov/professional/assessment/screens/pc-ptsd.asp
Selner-O'Hagan MB, Kindlon DJ, Buka SL, Raudenbush SW, Earls FJ. Assessing exposure to violence in urban youth. J Child Psychol Psychiatry. 1998 Feb;39(2):215-24.
PubMed 9669234Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
PubMed 6668417Weathers FW, Bovin MJ, Lee DJ, Sloan DM, Schnurr PP, Kaloupek DG, Keane TM, Marx BP. The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5): Development and initial psychometric evaluation in military veterans. Psychol Assess. 2018 Mar;30(3):383-395. doi: 10.1037/pas0000486. Epub 2017 May 11.
PubMed 28493729
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness for at Risk Youth: Understanding Substance Use and Important Mechanisms of Change
- ClinicalTrials.gov ID
- NCT04160754
- Acronym / sponsor ID
- up-18-00230
- Keywords
- Trauma, Delinquency, Substance Use, Emotion Regulation, Impulsivity, Executive Functioning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 5 Mar 2019 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 13 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will be the first to explore mindfulness as a prevention intervention among transition age youth and those with previous involvement in the juvenile or criminal justice system with substance use problems and history of exposure to violence/trauma. The study will focus on preventing escalation of substance use (e.g., alcohol and marijuana), trauma symptoms, and recidivism by using an intervention to target self-regulation and executive functioning.
Justice involved youth have higher rates of alcohol use and related consequences and higher rates of exposure to violence (Post Traumatic Stress Disorder) compared to their non-justice involved peers. Prior research has found aspects of self-regulation (emotion regulation, impulse control), stress, and craving to be important putative targets in reducing alcohol use. With high rates of recidivism and increased risk of long term problems associated with substance use, it is imperative to test interventions that can reach at risk youth and target both alcohol use and important psychological and neurocognitive self-regulation mechanisms.
This study tests whether the use of Mindfulness-Based Relapse Prevention (MBRP) for at risk young adults results in changes in important self-regulation mechanisms and improved alcohol use outcomes. Individuals assigned to the experimental group will receive interventions normally provided at a community clinic and eight 1.5-hour group sessions of MBRP. Sessions will occur once per week. Each session will target a specific theme such as being aware of personal triggers, maintaining present focus, allowing or letting things be, responding to emotional and physical experiences in skillful ways, and recognizing intrusive thoughts. Further, each session will incorporate a mindfulness meditation technique.
The central hypothesis will be tested through a focus on three specific aims: (1) Beta pilot testing and refining MBRP based on feedback from focus groups, (2) testing the efficacy of MBRP on substance use outcomes compared to an active control, and (3) assessing mechanisms of change for MBRP including self-regulation and neurocognitive facets such as working memory and inhibition.
Detailed description
The long-term goal of this proposal is to improve alcohol use outcomes by targeting emotion regulation (ER), impulsivity (IMP), and executive functioning (EF) constructs among racially and ethnically diverse (primarily Hispanic and Black) at risk young adults. With a similar population, the investigators pilot tested a novel Mindfulness-Based Intervention (MBI), Mindfulness-Based Substance Abuse Treatment for Adolescents (MBRP) with with marginalized young adults. Findings from adolescent samples have found support for the intervention's effect on problem behaviors, decision making, and self-esteem. However, extent research in this area has not assessed substance use or self-regulation. In a sample of marginalized young adults receiving treatment at a residential treatment facility, MBRP was found to significantly decrease stress and substance use outcomes. In addition, only one study has investigated the effect of a MBI on neurocognitive functioning with justice-involved youth. Unfortunately, this was not a clinical intervention and did not assess EF as a mechanism of change. The current study proposes to recruit 70-80 young adults (aged 18-26) referred to one clinic in Los Angeles, CA. The study site has a wide range of referral sources ranging from self-referral to referrals from the justice system.
Some young adults are referred to treatment by schools in lieu of engaging law enforcement or in lieu of expulsion, with many being self-referred.
Participants will be randomly assigned to receive MBRP or attention control (CTL). Participants will engage in both self-report and task-based ER, IMP, and EF measures pre- and post-intervention. Participants will be followed for 3 months post-intervention to assess effects on alcohol use and behavioral health outcomes, and putative mechanisms of change.
The central hypothesis is that MBRP, compared to CTL, will prompt change in ER, IMP, and EF. Further, it is hypothesized that these changes will be associated with better alcohol use outcomes 3 months post-intervention. The rationale for using a MBI with marginalized youth is that prior research has shown significantly worse self-regulation compared to community youth, and MBRP is specifically designed to aid in regulating emotions, decision making, and attention control. The unique strengths of this proposal are its use of an MBI; focus on a disadvantaged population of diverse racial and ethnic groups; focus on putative targets essential to behavioral health outcomes; and use of multiple neurocognitive tasks addressing important self-regulation components. The study objective is to test following three aims:
Specific Aim 1: Determine feasibility and acceptability of abbreviated MBRP. An adapted MBRP protocol will be beta-tested with 15 transition age youth/young adults. Focus groups will be conducted to evaluate the feasibility and acceptability of an intervention focused on enhancing self-regulation, refine content based on feedback, and addressing issues that might affect the successful completion of pilot testing in Aim 2.
Specific Aim 2: Pilot test MBRP intervention on putative targets by randomly assigning young adults who screen for past-month alcohol use/problems to MBRP or CTL. Determine the effect of the program on secondary outcomes of interest and putative targets for ER, IMP, and EF.
Specific Aim 3: Assess MBRP mechanisms by exploring whether effects of the intervention on our substance use outcomes can be partially explained by changes in target mechanisms: ER, IMP, and EF.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MBRP | Experimental | Behavioral: Mindfulness Based Relapse PreventionThe experimental group will receive treatment as usual plus eight Mindfulness based relapse prevention (MBRP) therapy sessions. |
| Control (CTL) | Active comparator | Behavioral: Control (CTL)The CTL group will receive treatment as usual plus information on the neurobiology of addiction and healthy behaviors. |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 18 to 26 years old at baseline
- English speaking
- Be willing to provide follow-up information
- Report past-month use of alcohol or drugs
- Score 2 or higher on the PC-PTSD scale
Key exclusion criteria (3 listed)
- Does not speak English
- Receiving treatment from some other facility for substance use.
- Active psychosis symptoms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness Based Relapse PreventionIndividuals assigned to the experimental group will receive interventions normally provided at the clinic and eight 1.5-hour group sessions of MBRP. Each sessions will occur once per week and will target a specific theme such as being aware of personal triggers, maintaining present focus, allowing or letting things be, responding to emotional and physical experiences in skillful ways, and recognizing intrusive thoughts. Each session will incorporate a mindfulness meditation technique (e.g.,SOBER breathing space and "urge surfing"). Participants will receive materials (e.g., recordings) with which to perform practices and meditation during the intervention phase. | Behavioural | MBRP |
| Control (CTL)Individuals assigned to the CTL group will receive interventions provided at the clinic and up to eight CTL sessions. The CTL group will receive information (reading) and videos once per week on health behaviors (e.g., exercise, eating) and the neurobiology of addiction. This approach will reduce the possibility that intervention effects are solely due to the experimental group's receiving extra attention. In contrast to the active intervention, sessions will be educational in nature, with no motivational, cognitive, or behavioral components | Behavioural | Control (CTL) |
Primary outcome
Change in Substance Use
Time frame: Baseline, 1 month, 2 months, 3 months, 4 months, 5 months
Substance use will be measured using time line follow back approach for 15 different substances. We will ask about days of use and number of times used for each substance in the past month
Change in PTSD symptoms
Time frame: Baseline, 1 month, 2 months, 3 months, 4 months, 5 months
Initial screening of PTSD symptoms will be assessed by the Primary Care PTSD Screen for DSM-5 (PC-PTSD-5). We will further assess PTSD symptoms using the PTSD Checklist for DSM-5 (PCL-5). The PCL-5 is a 20-item self-report measure that assesses the 20 Diagnostic and Statistical Manual of Mental Disorders (DSM-5) symptoms of PTSD.
Change in Depression
Time frame: Baseline, 1 month, 2 months, 3 months, 4 months, 5 months
Depression will be measured with the Center for Epidemiologic Studies Depression Scale (CES-D). The CES-D includes 20 items instructing participants how often they have experienced a variety of symptoms in the past week, ranging from "rarely or none of the time" to "Most or all of the time." The scoring of positive items is reversed. Possible range of scores is zero to 60, with the higher scores indicating the presence of more symptomology.
6 secondary outcomes
Executive Functioning
Time frame: Baseline, 2 months post-baseline
Emotion Regulation
Time frame: Baseline, 1 month, 2 months, 3 months, 4 months, 5 months
Impulsivity
Time frame: Baseline, 1 month, 2 months, 3 months, 4 months, 5 months
Delinquency
Time frame: Baseline, 1 month, 2 months, 3 months, 4 months, 5 months
Stress
Time frame: Baseline, 1 month, 2 months, 3 months, 4 months, 5 months
Violence Perpetration
Time frame: Baseline, 1 month, 2 months, 3 months, 4 months, 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
- Background: PubMed 8039375Bechara A, Damasio AR, Damasio H, Anderson SW. Insensitivity to future consequences following damage to human prefrontal cortex. Cognition. 1994 Apr-Jun;50(1-3):7-15. doi: 10.1016/0010-0277(94)90018-3.
- Background: PubMed 24636739Cyders MA, Littlefield AK, Coffey S, Karyadi KA. Examination of a short English version of the UPPS-P Impulsive Behavior Scale. Addict Behav. 2014 Sep;39(9):1372-6. doi: 10.1016/j.addbeh.2014.02.013. Epub 2014 Mar 3.
- Background: PubMed 29910013Davis JP, Berry D, Dumas TM, Ritter E, Smith DC, Menard C, Roberts BW. Substance use outcomes for mindfulness based relapse prevention are partially mediated by reductions in stress: Results from a randomized trial. J Subst Abuse Treat. 2018 Aug;91:37-48. doi: 10.1016/j.jsat.2018.05.002. Epub 2018 May 20.
- BackgroundEspelage, D. L., & Holt, M. K. (2001). Bullying and victimization during early adolescence: Peer influences and psychosocial correlates. Journal of Emotional Abuse, 2(2-3), 123-142. https://doi.org/10.1300/J135v02n02_08
- Background: PubMed 29725312Hallion LS, Steinman SA, Tolin DF, Diefenbach GJ. Psychometric Properties of the Difficulties in Emotion Regulation Scale (DERS) and Its Short Forms in Adults With Emotional Disorders. Front Psychol. 2018 Apr 19;9:539. doi: 10.3389/fpsyg.2018.00539. eCollection 2018.
- BackgroundHimelstein, S. (2011). Mindfulness-Based Substance Abuse Treatment for Incarcerated Youth: A Mixed Method Pilot Study. International Journal of Transpersonal Studies, 1-10.
- BackgroundHimelstein, Sam, Hastings, A., Shapiro, S., & Heery, M. (2012). Mindfulness training for self-regulation and stress with incarcerated youth. Probation Journal, 59(2), 151-165. https://doi.org/10.1177/0264550512438256
- Background: PubMed 24611851Himelstein S, Saul S, Garcia-Romeu A, Pinedo D. Mindfulness training as an intervention for substance user incarcerated adolescents: a pilot grounded theory study. Subst Use Misuse. 2014 Apr;49(5):560-70. doi: 10.3109/10826084.2013.852580.
- Background: PubMed 21707183Jackson JD, Balota DA. Mind-wandering in younger and older adults: converging evidence from the Sustained Attention to Response Task and reading for comprehension. Psychol Aging. 2012 Mar;27(1):106-119. doi: 10.1037/a0023933. Epub 2011 Jun 27.
- Background: PubMed 24265621Leonard NR, Jha AP, Casarjian B, Goolsarran M, Garcia C, Cleland CM, Gwadz MV, Massey Z. Mindfulness training improves attentional task performance in incarcerated youth: a group randomized controlled intervention trial. Front Psychol. 2013 Nov 8;4:792. doi: 10.3389/fpsyg.2013.00792. eCollection 2013.
- BackgroundPrins, A., Bovin, M. J., Kimerling, R., Kaloupek, D. G., Marx, B. P., Pless Kaiser, A., & Schnurr, P. P. (2015). The Primary Care PTSD Screen for DSM-5 (PC-PTSD-5) [Measurement Instrument]. Retrieved from https://www.ptsd.va.gov/professional/assessment/screens/pc-ptsd.asp
- Background: PubMed 9669234Selner-O'Hagan MB, Kindlon DJ, Buka SL, Raudenbush SW, Earls FJ. Assessing exposure to violence in urban youth. J Child Psychol Psychiatry. 1998 Feb;39(2):215-24.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Based Relapse Prevention in people with Alcohol Use, Underage and Alcohol Problem Drinking, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Substance Use (time frame: Baseline, 1 month, 2 months, 3 months, 4 months, 5 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04160754, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2021.