Project RAD: A Brief Intervention for Young Adult Alcohol or Marijuana Users

NCT03801096 | Unknown

• 1 other identifier: 00001218
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a pilot study of the feasibility, acceptability, and effectiveness of a brief, one-session intervention for a diverse sample of 44 young adults who report alcohol binge drinking or marijuana use in the past month. The proposed study will utilize a two-group randomized controlled trial (RCT) design. Participants will be randomized to one of two interventions conditions: 1) Narrative-based Therapeutic Assessment (NbTa) or 2) Health Education (HE) control condition. Participants will be assessed on their 7- and 30-day alcohol and marijuana use at baseline and at 6 month follow-up.

Conditions

Alcohol; Use, Problem; Marijuana Usage

Outcome Measures

Primary Outcomes (4)

• Weekly Alcohol Use Frequency at 6 month follow-up

  Self-reported days of alcohol use in the past 7 days captured and computed using the Timeline Follow Back (Sobel \& Sobel, 1992).

  6 months after baseline

• Monthly Alcohol Use Frequency at 6 month follow-up

  Self-reported days of alcohol use in the past 30 days captured and computed using the Timeline Follow Back (Sobel \& Sobel, 1992).

  6 months after baseline

• Weekly Marijuana Use Frequency at 6 month follow-up

  Self-reported days of marijuana use in the past 7 days captured and computed using the Timeline Follow Back (Sobel \& Sobel, 1992) and confirmed with Urine drug screening tests.

  6 months after baseline

• Monthly Marijuana Use Frequency at 6 month follow-up

  Self-reported days of marijuana use in the past 30 days captured and computed using the Timeline Follow Back (Sobel \& Sobel, 1992) and confirmed with Urine drug screening tests.

  6 months after baseline

Study Arms (2)

Narrative Based Therapuetic Assessment

EXPERIMENTAL

Behavioral: Narrative Based Therapuetic Assessment (NbTa)

Health Education (HE)

ACTIVE COMPARATOR

Behavioral: Health Education Control Condition (HE)

Interventions

Narrative Based Therapuetic Assessment (NbTa) BEHAVIORAL

The NbTa interventiom will guide participants through an exploration of their human experience through stories and narratives. The interventionist will facilitate a collaborative process by which participants will explore the unique themes and meanings of their personal narrative (Parry \& Doan, 1994) with respect to alcohol and drug use. In addition, participants will also be guided towards considering the re-authorship of personal narratives. The techniques utilized in NbTa aim to dislodge problem saturated narratives and derive more complete personal narratives and meanings (White \& Epston, 1990).

Narrative Based Therapuetic Assessment

Health Education Control Condition (HE) BEHAVIORAL

The Health Education session is a didactic 45-minute session that focusses on three health-related topics: 1) Sleep, 2) Physical Activity, and 3) Nutrition. The goal of the session is to present health-related information to participants through videos and dydadic presentation.

Health Education (HE)

Eligibility Criteria

• Age: 18 Years - 25 Years
• Gender Eligibility Details: All self-represented gender identities will be included.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Between the ages of 18 and 25.
• Able to speak and read the English language.
• Agree to participate in the study and be available for two study visits that will occur at baseline and approximately 6-month after the baseline visit.
• Report at least 1 alcohol binge drinking episode in the past month (binge drinking is defined as 4 or more drinks in a 2 hour period for women, 5 or more drinks in a 2 hour period for men (NIAAA, 2004) OR report the use of marijuana on at least 1 occasion in the past month.
• Have access to an email account or phone number to communicate with study personnel.
• Identify as a member of a minority group, disadvantaged group, or marginalized based on race, ethnicity, heritage, immigration status, gender, sexual orientation, religion, and disability status.

You may not qualify if:

• In the past month, consumed an average of 7 or more drinks per week for females or 14 or more drinks per week for males.
• Marijuana use on 4 or more days per week in the past month.
• A pattern of impaired functioning due to alcohol or marijuana use during the past month;
• In the past year, family members, close friends, or medical providers have expressed concerns about their alcohol or marijuana use and have advised them to quit.
• A history of a Substance Use Disorders (Alcohol; Amphetamines; Cannabis; Cocaine; Hallucinogens; Opioids; Phencyclidine; and Sedatives, Hypnotics and Anxiolytics).
• A history of a chronic and/or severe psychiatric disorder that would interfere with participation (i.e., Schizophrenia, Delusional Disorder, Schizoaffective Disorder, Bipolar Disorder, or a Mood Disorder with Psychotic Features).
• Unavailable for a 2.5 hour baseline visit and a follow-up visit 6 months post baseline.
• Unable to provide contact information to allow for study related communication.
• Pregnant or nursing.
• Identified as a UH student that the PI (Dr. Marcel de Dios) has had or will likely have direct access to or influence over through academic activities such as coursework, advising, or research mentoring.
• Identified by the study PI as unsuitable for participating in the study due to significant circumstances that would interfere with participation including threatening behavior or an inability/unwillingness to respond to basic study related questions and instructions.

Sponsors & Collaborators

• University of Houston: lead

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Central Study Contacts

Marcel de Dios

CONTACT

7137436687; madedios@central.uh.edu

Lycinda Rodriguez, MS

CONTACT

7137436686; lrodriguez1@loyola.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Research Assistant collecting data will be blinded to condition
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Two-group randomized controlled trial (RCT) design

Study Record Dates

• First Submitted: January 8, 2019
• First Posted: January 11, 2019
• Study Start: January 1, 2019
• Primary Completion: March 1, 2020
• Study Completion: October 1, 2020
• Last Updated: January 11, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share