Alcohol UseNCT02252471
Choices-Teen: A Bundled Risk Reduction Intervention for Juvenile Justice Females
A study testing Choices-Teen in people with Alcohol Use and Smoking, run by University of Houston.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 to 17 years, women only
- Conditions the study is for
- Alcohol Use, Smoking, Contraception
- What is being tested?
- Choices-Teen
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- Jul 2012to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 17 years
- Women only
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Pregnant
- Infertile
- Insufficient locator information
- Language other than English
About this study
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).
Read the detailed description
The overall objective of this study is to assess the feasibility and promise of an adapted CHOICES preconception intervention (CHOICES-TEEN) in reducing the risk of HIV, nicotine-exposed pregnancy (NEP), and alcohol-exposed pregnancy (AEP) in adolescent females on intensive community probation. The current study posits that a two-session CHOICES intervention adapted to target multiple bundled health risks-AEP, NEP, and HIV-will be feasible, acceptable, and promising in reducing these risks among females on community-based juvenile probation. This study will: Aim 1: Modify the efficacious CHOICES preconception intervention to target the prevention of HIV, AEP, and NEP. The result will be a two session individual intervention (CHOICES-TEEN) and accompanying therapy manual based on the Transtheoretical Model (TTM) and Motivational Interviewing. Aim 2: Conduct a one-arm feasibility trial with females in the juvenile justice system to assess the promise of CHOICES-TEEN. 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, NEP, and AEP). This study will inform subsequent Stage II/III behavioral intervention studies and contribute to a missing, fundamental element in the knowledge base - further understanding of the feasibility of targeting bundled health risks in high-risk adolescents, and the potential promise of a gender-specific intervention for this population.
- Conditions
- Alcohol Use, Smoking, Contraception, HIV
- Being tested
- Choices-Teen
- Keywords
- alcohol-exposed pregnancy, nicotine-exposed pregnancy, tobacco-exposed pregnancy, alcohol, contraception, smoking, pregnancy, HIV, prevention
- Medical subject headings
- Alcohol Drinking, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Choices-TeenBehavioural
Choices-Teen participants in this condition will receive two brief motivational-interviewing-based counseling sessions, and one counseling session with a physician.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Choices-Teen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk of alcohol-exposed pregnancy
Timeline Followback Interview
Measured: 3 months
Risk of nicotine-exposed pregnancy
Timeline Followback Interview
Measured: 3 months
HIV risk
Timeline Followback Interview
Measured: 3 months
Secondary outcomes (6)
Excessive alcohol consumption
AUDIT Scale
Measured: 3 months
Psychological distress and symptoms
Brief Symptom Inventory -18
Measured: 3 months
Pros and cons of engaging in health risk behaviors (alcohol, smoking, HIV)
Decisional Balance Scale
Measured: 3 months
Experiential and behavioral processes of change for health risk behaviors (alcohol, smoking, HIV)
Processes of Change Questionnaire
Measured: 3 months
Temptation to engage in health risk behaviors (alcohol, smoking, HIV)
Temptation Scale
Measured: 3 months
Confidence/self-efficacy to not engage in health risk behaviors (alcohol, smoking, HIV)
Confidence Scale
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2014 (estimated)
- Study startJul 2012
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Danielle Parrish, University of Houston
- Investigators
- Danielle E Parrish, Ph.D., Principal investigator, University of Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02252471
- Sponsor's protocol ID
- 1R03DA034099-01
- Status last verified
- Sep 2014
- First submitted
- 20 Sep 2014
- Last updated
- 30 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Choices-Teen: A Bundled Risk Reduction Intervention for Juvenile Justice Females
- ClinicalTrials.gov ID
- NCT02252471
- Acronym / sponsor ID
- 1R03DA034099-01
- Conditions
- Alcohol Use, Smoking, Contraception, HIV
- Keywords
- alcohol-exposed pregnancy, nicotine-exposed pregnancy, tobacco-exposed pregnancy, alcohol, contraception, smoking, pregnancy, HIV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of HoustonUniversity, hospital or other
- Collaborators
- The University of Texas Health Science Center, Houston
- Study start
- Jul 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 30 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
The overall objective of this study is to assess the feasibility and promise of an adapted CHOICES preconception intervention (CHOICES-TEEN) in reducing the risk of HIV, nicotine-exposed pregnancy (NEP), and alcohol-exposed pregnancy (AEP) in adolescent females on intensive community probation. The current study posits that a two-session CHOICES intervention adapted to target multiple bundled health risks-AEP, NEP, and HIV-will be feasible, acceptable, and promising in reducing these risks among females on community-based juvenile probation. This study will: Aim 1: Modify the efficacious CHOICES preconception intervention to target the prevention of HIV, AEP, and NEP. The result will be a two session individual intervention (CHOICES-TEEN) and accompanying therapy manual based on the Transtheoretical Model (TTM) and Motivational Interviewing. Aim 2: Conduct a one-arm feasibility trial with females in the juvenile justice system to assess the promise of CHOICES-TEEN. 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, NEP, and AEP). This study will inform subsequent Stage II/III behavioral intervention studies and contribute to a missing, fundamental element in the knowledge base - further understanding of the feasibility of targeting bundled health risks in high-risk adolescents, and the potential promise of a gender-specific intervention for this population.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Choices-Teen Intervention | Experimental | Behavioral: Choices-TeenA 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. |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- Pregnant
- Infertile
- Insufficient locator information
- Language other than English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Choices-TeenChoices-Teen participants in this condition will receive two brief motivational-interviewing-based counseling sessions, and one counseling session with a physician. | Behavioural | Choices-Teen Intervention |
Primary outcome
Risk of alcohol-exposed pregnancy
Time frame: 3 months
Timeline Followback Interview
Risk of nicotine-exposed pregnancy
Time frame: 3 months
Timeline Followback Interview
HIV risk
Time frame: 3 months
Timeline Followback Interview
6 secondary outcomes
Excessive alcohol consumption
Time frame: 3 months
Psychological distress and symptoms
Time frame: 3 months
Pros and cons of engaging in health risk behaviors (alcohol, smoking, HIV)
Time frame: 3 months
Experiential and behavioral processes of change for health risk behaviors (alcohol, smoking, HIV)
Time frame: 3 months
Temptation to engage in health risk behaviors (alcohol, smoking, HIV)
Time frame: 3 months
Confidence/self-efficacy to not engage in health risk behaviors (alcohol, smoking, HIV)
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danielle E Parrish, Ph.D. principal investigator
University of Houston
Questions about this trial
What is this clinical trial studying?
A study testing Choices-Teen in people with Alcohol Use and Smoking, run by University of Houston.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk of alcohol-exposed pregnancy (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2014.