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
|Condition or disease||Intervention/treatment||Phase|
|Substance Use||Behavioral: Brief psycho-educational intervention||Not Applicable|
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.
|Study Type :||Interventional|
|Estimated Enrollment :||450 participants|
|Intervention Model:||Parallel Assignment|
|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|
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.
- 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.
- 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.
- 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.
- Medication Adherence measured by self-report [ Time Frame: 12 months post intervention ]
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
|United States, Massachusetts|
|Boston Children's Hospital|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Sharon Levy, MD, MPH||Boston Children’s Hospital|
|Principal Investigator:||Elissa Weitzman, ScD, MSc||Boston Children’s Hospital|