NCT02252471

Brief Summary

This pilot study will: 1) demonstrate the feasibility of delivering CHOICES-TEEN with master's level mental health professionals within a juvenile justice setting; 2) determine acceptance of CHOICES-TEEN as measured by client adherence, retention, and treatment satisfaction; and 3) assess client improvement at 3-month follow-up (e.g., reduction of risk of HIV, nicotine-exposed pregnancy, and alcohol-exposed pregnancy).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2012

Typical duration for not_applicable

Status
completed

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

Study Start

First participant enrolled

July 1, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 30, 2014

Completed
Last Updated

September 30, 2014

Status Verified

September 1, 2014

Enrollment Period

1.9 years

First QC Date

September 20, 2014

Last Update Submit

September 25, 2014

Conditions

Keywords

alcohol-exposed pregnancynicotine-exposed pregnancytobacco-exposed pregnancyalcoholcontraceptionsmokingpregnancyHIVprevention

Outcome Measures

Primary Outcomes (3)

  • Risk of alcohol-exposed pregnancy

    Timeline Followback Interview

    3 months

  • Risk of nicotine-exposed pregnancy

    Timeline Followback Interview

    3 months

  • HIV risk

    Timeline Followback Interview

    3 months

Secondary Outcomes (6)

  • Excessive alcohol consumption

    3 months

  • Psychological distress and symptoms

    3 months

  • Pros and cons of engaging in health risk behaviors (alcohol, smoking, HIV)

    3 months

  • Experiential and behavioral processes of change for health risk behaviors (alcohol, smoking, HIV)

    3 months

  • Temptation to engage in health risk behaviors (alcohol, smoking, HIV)

    3 months

  • +1 more secondary outcomes

Study Arms (1)

Choices-Teen Intervention

EXPERIMENTAL

A three session intervention with two counseling sessions with a master's level therapist and a counseling session with a physician. The counseling with the master's level therapist utilizes a motivational interviewing approach to encourage changes in alcohol use, contraceptive use, smoking and HIV risk behaviors. This part of the intervention (a) provides norms-based-but personalized-feedback; (b) encourages participating in the smoking cessation program; (c) increases motivation to change each of the target behaviors; (d) decreases temptation to engage in risk behaviors; (e) increases confidence to avoid risk behaviors; and (f) develops a personalized, tailored change plan. The physician session provides individualized contraception and HIV risk reduction counseling.

Behavioral: Choices-Teen

Interventions

Choices-TeenBEHAVIORAL

Choices-Teen participants in this condition will receive two brief motivational-interviewing-based counseling sessions, and one counseling session with a physician.

Choices-Teen Intervention

Eligibility Criteria

Age14 Years - 17 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Have had vaginal intercourse with a male in the last 90 days
  • Inconsistent/ineffective contraception use
  • Inconsistent/ineffective condom use
  • Drinking at risk levels
  • Smoking
  • Available for the follow-up period

You may not qualify if:

  • Pregnant
  • Infertile
  • Insufficient locator information
  • Language other than English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Alcohol DrinkingSmoking

Condition Hierarchy (Ancestors)

Drinking BehaviorBehavior

Study Officials

  • Danielle E Parrish, Ph.D.

    University of Houston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 20, 2014

First Posted

September 30, 2014

Study Start

July 1, 2012

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

September 30, 2014

Record last verified: 2014-09