Clinical trial NCT02803567: 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
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: Conrad N. Hilton Foundation
First posted: 2016-06-17
Enrollment: 460
Sex: ALL
Minimum age (years): 14
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Frequency and quantity of alcohol use in the past 12 months, measured using the Screen to Brief Intervention (S2BI) screening tool.
timeFrame: 12 months post intervention
Secondary outcomes:
measure: Frequency of marijuana use in the past 12 months, measured using the S2BI Screening Tool.
timeFrame: 12 months post intervention
measure: Perceived risk of harm of substance use
timeFrame: 12 months post intervention
measure: Medication Adherence measured by self-report
timeFrame: 12 months post intervention
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Sharon Levy, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston Children's Hospital
name: Elissa Weitzman, ScD, MSc
role: PRINCIPAL_INVESTIGATOR
References: