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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01709201
Other study ID # FP01009751
Secondary ID
Status Withdrawn
Phase N/A
First received October 15, 2012
Last updated June 19, 2017
Start date July 2013
Est. completion date June 2015

Study information

Verified date June 2017
Source Boston Children’s Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date June 2015
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender All
Age group 14 Years to 18 Years
Eligibility Inclusion Criteria:

- 14-18 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

Exclusion Criteria:

- 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

Study Design


Intervention

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

Locations

Country Name City State
United States Boston Children's Hospital Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Boston Children’s Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Percent Days Abstinent 90 days post baseline We will compare the percent days abstinent from substances between the Treatment as Usual and Intervention groups 90 days post baseline 90 days post baseline
Other Medical complications 90 days post baseline We will evaluate the incidents of disease complications between the Treatment as Usual and Intervention groups 30 days post baseline 90 days post baseline
Primary 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 Medical complications We will evaluate the incidents of disease complications between the Treatment as Usual and Intervention groups 30 days post baseline 30 days post baseline
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