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Trial of a Novel Brief Intervention on Health Behaviors for Youth With Chronic Medical Conditions

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ClinicalTrials.gov Identifier: NCT02803567
Recruitment Status : Active, not recruiting
First Posted : June 17, 2016
Last Update Posted : January 30, 2019
Sponsor:
Collaborator:
Conrad N. Hilton Foundation
Information provided by (Responsible Party):
Sharon Levy, Boston Children’s Hospital

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.

Condition or disease Intervention/treatment Phase
Substance Use Behavioral: Brief psycho-educational intervention Not Applicable

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.


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Study Type : Interventional
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Trial of a Novel Brief Intervention on Health Behaviors for Youth With Chronic Medical
Actual Study Start Date : April 1, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

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

No Intervention: Control
Those in the control arm will receive treatment as usual.



Primary Outcome Measures :
  1. Frequency and quantity of alcohol use in the past 12 months, measured using the Screen to Brief Intervention (S2BI) screening tool. [ Time Frame: 12 months post intervention ]
    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 :
  1. Frequency of marijuana use in the past 12 months, measured using the S2BI Screening Tool. [ Time Frame: 12 months post intervention ]
    We will compare changes frequency of marijuana use in the past 12 months between the intervention and treatment as usual groups.

  2. Perceived risk of harm of substance use [ Time Frame: 12 months post intervention ]
    We will compare self-reported perceived risk of harm of substance use between intervention and TAU groups using Monitoring the Future questions.

  3. Medication Adherence measured by self-report [ Time Frame: 12 months post intervention ]


Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02803567


Locations
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United States, Massachusetts
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Boston Children’s Hospital
Conrad N. Hilton Foundation
Investigators
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Principal Investigator: Sharon Levy, MD, MPH Boston Children’s Hospital
Principal Investigator: Elissa Weitzman, ScD, MSc Boston Children’s Hospital

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Responsible Party: Sharon Levy, Associate Professor of Pediatrics, Boston Children’s Hospital
ClinicalTrials.gov Identifier: NCT02803567     History of Changes
Other Study ID Numbers: P00021649
First Posted: June 17, 2016    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data will not be made available. We will provide our findings in aggregate.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No