Trial of a Novel Brief Intervention on Health Behaviors for Youth With Chronic Medical Conditions
Primary Purpose
Substance Use
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brief psycho-educational intervention
Sponsored by
About this trial
This is an interventional prevention trial for Substance Use
Eligibility Criteria
Inclusion Criteria:
- 14-17 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.
Exclusion Criteria:
- 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
Sites / Locations
- Boston Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
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.
Those in the control arm will receive treatment as usual.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Frequency of marijuana use in the past 12 months, measured using the S2BI Screening Tool.
We will compare changes frequency of marijuana use in the past 12 months between the intervention and treatment as usual groups.
Perceived risk of harm of substance use
We will compare self-reported perceived risk of harm of substance use between intervention and TAU groups using Monitoring the Future questions.
Medication Adherence measured by self-report
Full Information
NCT ID
NCT02803567
First Posted
March 3, 2016
Last Updated
July 7, 2020
Sponsor
Boston Children's Hospital
Collaborators
Conrad N. Hilton Foundation
1. Study Identification
Unique Protocol Identification Number
NCT02803567
Brief Title
Trial of a Novel Brief Intervention on Health Behaviors for Youth With Chronic Medical Conditions
Official Title
Trial of a Novel Brief Intervention on Health Behaviors for Youth With Chronic Medical
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
November 26, 2019 (Actual)
Study Completion Date
November 26, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Children's Hospital
Collaborators
Conrad N. Hilton Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
The proposed project is a randomized control trial to assess the efficacy of an SBIRT model tailored to youth with chronic medical conditions. This trial is being built into a larger, longitudinal cohort study to assess whether a set of brief, substance specific questions can accurately predict adolescent substance use outcomes when compared to more lengthy, criterion standard assessment questions, in cross-sectional and prospective analysis. The first component of the project will consist of pre-testing an assessment battery and brief electronic intervention with a small sample of 14-17 year old youth. In the second component the investigators will randomize consented eligible participants into intervention or control arms of the study and administer the 1) Baseline Assessment Battery and the 2) Brief Intervention OR Treatment as Usual (TAU). In the third component the investigators will follow up with all participants at 6 and then 12 months after study entry to reassess rates of substance use through follow up assessment batteries.
At baseline, the investigators will also attempt to enroll parents of all participants who are present at the time of enrollment. The investigators will separately consent and administer a brief assessment battery to parents to assess their knowledge and attitudes around substance use, as well as opinions and attitudes regarding other health and risk behaviors.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
460 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Those in the control arm will receive treatment as usual.
Intervention Type
Behavioral
Intervention Name(s)
Brief psycho-educational intervention
Intervention Description
Participants in the intervention arm will receive a computerized brief intervention composed of tailored feedback and psycho-education specific to their chronic condition.
Primary Outcome Measure Information:
Title
Frequency and quantity of alcohol use in the past 12 months, measured using the Screen to Brief Intervention (S2BI) screening tool.
Description
We will compare changes in frequency and quantity of alcohol use over the past twelve months between the intervention and treatment as usual groups.
Time Frame
12 months post intervention
Secondary Outcome Measure Information:
Title
Frequency of marijuana use in the past 12 months, measured using the S2BI Screening Tool.
Description
We will compare changes frequency of marijuana use in the past 12 months between the intervention and treatment as usual groups.
Time Frame
12 months post intervention
Title
Perceived risk of harm of substance use
Description
We will compare self-reported perceived risk of harm of substance use between intervention and TAU groups using Monitoring the Future questions.
Time Frame
12 months post intervention
Title
Medication Adherence measured by self-report
Time Frame
12 months post intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
14-17 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.
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon Levy, MD, MPH
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elissa Weitzman, ScD, MSc
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will not be made available. We will provide our findings in aggregate.
Learn more about this trial
Trial of a Novel Brief Intervention on Health Behaviors for Youth With Chronic Medical Conditions
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