NCT01709201

Brief Summary

The investigators goal is to pilot a substance use-related brief intervention (BI) for youth with chronic medical conditions, obtaining preliminary evidence of feasibility, acceptability and impacts of the approach for reducing substance use among this group.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 15, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 18, 2012

Completed
9 months until next milestone

Study Start

First participant enrolled

July 1, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

June 21, 2017

Status Verified

June 1, 2017

Enrollment Period

1.4 years

First QC Date

October 15, 2012

Last Update Submit

June 19, 2017

Conditions

Alcohol AbuseDrug Abuse

Keywords

Alcohol abuseDrug abuseDiabetes MellitusPersistent AsthmaJuvenile ArthritisUlcerative Colitis

Outcome Measures

Primary Outcomes (1)

  • Percent days abstinent

    We will compare the percent days abstinent from substances between the Treatment as Usual and Intervention groups 30 days post baseline

    30 days post baseline

Secondary Outcomes (1)

  • Medical complications

    30 days post baseline

Other Outcomes (2)

  • Percent Days Abstinent 90 days post baseline

    90 days post baseline

  • Medical complications 90 days post baseline

    90 days post baseline

Study Arms (2)

Treatment as Usual

NO INTERVENTION

Those in the Treatment as Usual group will not receive the brief intervention for substance use but will receive a brief health education brochure.

Brief Intervention

EXPERIMENTAL

Those in the Brief Intervention group will receive a brief motivational intervention aimed at encouraging the participant to decrease their substance use.

Behavioral: Brief Intervention

Interventions

Brief InterventionBEHAVIORAL

Those in the intervention arm will undergo a 10-minute discussion with a trained interventionist aimed at encouraging decreased substance use.

Brief Intervention

Eligibility Criteria

Age14 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • years old
  • Currently being treated for diabetes, rheumatologic disorders, asthma, or ulcerative colitis (UC) at Boston Children's Hospital with a duration of chronic illness of at least one year
  • Previous participation in the screening validation study
  • Evidence of problems related to substance use

You may not qualify if:

  • Medically or emotionally unstable or otherwise unable to provide assent/consent
  • Unable to speak/read English
  • Unable to use a computer keyboard and/or complete an interviewer-assisted questionnaire

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

AlcoholismSubstance-Related DisordersDiabetes MellitusArthritis, JuvenileColitis, Ulcerative

Interventions

Crisis Intervention

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersChemically-Induced DisordersMental DisordersGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Sharon Levy, MD, MPH

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR

  • Elissa Weitzman, ScD, MSc

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Pediatrics, Harvard Medical School

Study Record Dates

First Submitted

October 15, 2012

First Posted

October 18, 2012

Study Start

July 1, 2013

Primary Completion

December 1, 2014

Study Completion

June 1, 2015

Last Updated

June 21, 2017

Record last verified: 2017-06

Locations

US(1)