NCT03401333

Brief Summary

This study tests the feasibility of an intervention to prevent risky alcohol or marijuana use that adds a 4-week course of tailored text messaging to a brief motivational intervention for 13-18-year-old adolescents.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 14, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 17, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2018

Completed
Last Updated

October 23, 2018

Status Verified

October 1, 2018

Enrollment Period

7 months

First QC Date

January 9, 2018

Last Update Submit

October 22, 2018

Conditions

Outcome Measures

Primary Outcomes (3)

  • Enrollment

    Number of participants per month that enroll in the study

    Baseline

  • Retention

    % of enrolled participants that complete the 4-week follow up assessments

    4 weeks

  • Satisfaction

    Participant's rating of how much they like the intervention (Likert scale)

    4 weeks

Study Arms (1)

Text messaging and brief intervention

EXPERIMENTAL

Brief motivational interview and 4-weeks of text messaging.

Behavioral: Text Messaging and Brief Negotiation Interview

Interventions

An in-person brief motivational intervention coupled with 4 weeks of motivational text messages

Text messaging and brief intervention

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • to 18 years old
  • Able to provide consent or assent and parental permission
  • have a functioning cell phone without pay-as-you-go text messaging

You may not qualify if:

  • currently enrolled in any substance abuse program;
  • have medical/psychiatric condition that precludes participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Alcohol DrinkingMarijuana Abuse

Condition Hierarchy (Ancestors)

Drinking BehaviorBehaviorSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: A brief motivational interview and four weeks of text messaging.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2018

First Posted

January 17, 2018

Study Start

November 14, 2017

Primary Completion

June 6, 2018

Study Completion

June 6, 2018

Last Updated

October 23, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

IPD will not be shared

Locations