NCT02803567

Brief Summary

The primary goal of this project is to develop a tailored screening, brief intervention and referral to treatment (SBIRT) model for youth with chronic medical conditions (YCMC) for delivery at point of care during a routine healthcare visit, through conducting a rigorous randomized control trial among adolescent patients with type 1 diabetes (TID) or rheumatologic conditions. The secondary goal is to assess the attitudes and knowledge of parents of these same adolescents, to explore links between parent beliefs and adolescent behavior around substance use.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
460

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2017

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2016

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 17, 2016

Completed
10 months until next milestone

Study Start

First participant enrolled

April 1, 2017

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 26, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 26, 2019

Completed
Last Updated

July 8, 2020

Status Verified

July 1, 2020

Enrollment Period

2.7 years

First QC Date

March 3, 2016

Last Update Submit

July 7, 2020

Conditions

Substance Use

Outcome Measures

Primary Outcomes (1)

  • Frequency and quantity of alcohol use in the past 12 months, measured using the Screen to Brief Intervention (S2BI) screening tool.

    We will compare changes in frequency and quantity of alcohol use over the past twelve months between the intervention and treatment as usual groups.

    12 months post intervention

Secondary Outcomes (3)

  • Frequency of marijuana use in the past 12 months, measured using the S2BI Screening Tool.

    12 months post intervention

  • Perceived risk of harm of substance use

    12 months post intervention

  • Medication Adherence measured by self-report

    12 months post intervention

Study Arms (2)

Intervention

EXPERIMENTAL

Those in the intervention arm will receive a computerized brief intervention composed of tailored feedback and psycho-education on substance use. Content in the intervention will focus on health promotion and will deliver positive messages about health.

Behavioral: Brief psycho-educational intervention

Control

NO INTERVENTION

Those in the control arm will receive treatment as usual.

Interventions

Brief psycho-educational interventionBEHAVIORAL

Participants in the intervention arm will receive a computerized brief intervention composed of tailored feedback and psycho-education specific to their chronic condition.

Intervention

Eligibility Criteria

Age14 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • year-old youth presenting for routine medical care in the Rheumatology clinic or Endocrinology clinic at Boston Children's Hospital (BCH)
  • A diagnosis of type 1 diabetes for at least a year or a diagnosis of a Rheumatologic condition for at least a year.
  • Able to read and understand English at a middle school level or greater
  • Consent to participation in the study and consent to the 6 month and 12 month follow up assessments.

You may not qualify if:

  • Patients who are medically or emotionally unstable or otherwise unable to provide assent at the time of their appointment as determined by their clinician or the research team
  • Unable to speak/read English at a middle school reading level
  • Unable to use a computer keyboard and/or complete an interviewer-assisted questionnaire
  • Do not consent to 6 month and 12 month re-assessment.
  • Patients who are pregnant at baseline

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

  • Weitzman ER, Minegishi M, Dedeoglu F, Fishman LN, Garvey KC, Wisk LE, Levy S. Disease-Tailored Brief Intervention for Alcohol Use Among Youths With Chronic Medical Conditions: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2024 Jul 1;7(7):e2419858. doi: 10.1001/jamanetworkopen.2024.19858.

    PMID: 38985475DERIVED

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Sharon Levy, MD, MPH

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR

  • Elissa Weitzman, ScD, MSc

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Pediatrics

Study Record Dates

First Submitted

March 3, 2016

First Posted

June 17, 2016

Study Start

April 1, 2017

Primary Completion

November 26, 2019

Study Completion

November 26, 2019

Last Updated

July 8, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be made available. We will provide our findings in aggregate.

Locations

US(1)