- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02803567
Trial of a Novel Brief Intervention on Health Behaviors for Youth With Chronic Medical Conditions
Trial of a Novel Brief Intervention on Health Behaviors for Youth With Chronic Medical
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Massachusetts
-
Boston, Massachusetts, Förenta staterna, 02115
- Boston Children's Hospital
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
Participants in the intervention arm will receive a computerized brief intervention composed of tailored feedback and psycho-education specific to their chronic condition.
|
|
Inget ingripande: Control
Those in the control arm will receive treatment as usual.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Frequency and quantity of alcohol use in the past 12 months, measured using the Screen to Brief Intervention (S2BI) screening tool.
Tidsram: 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.
|
12 months post intervention
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Frequency of marijuana use in the past 12 months, measured using the S2BI Screening Tool.
Tidsram: 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.
|
12 months post intervention
|
|
Perceived risk of harm of substance use
Tidsram: 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.
|
12 months post intervention
|
|
Medication Adherence measured by self-report
Tidsram: 12 months post intervention
|
12 months post intervention
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Sharon Levy, MD, MPH, Boston Children's Hospital
- Huvudutredare: Elissa Weitzman, ScD, MSc, Boston Children's Hospital
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- P00021649
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Läkemedels- och apparatinformation, studiedokument
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