Prenatal Alcohol ExposureC4HNCT03633149
Choices4Health: Intervention to Prevent Substance-exposed Pregnancy
A study testing Computer tablet-delivered C4H, Person-delivered C4H and Brief Advice in people with Prenatal Alcohol Exposure and Prenatal Tobacco Exposure, run by University of Texas at Austin at 1 site in United States.
Trial summary
This is a 4-year randomized, controlled study to test the efficacy of the CHOICES4Health-T (C4H-T) delivered by a computerized tablet, CHOICES4Health-C (C4H-C), delivered by a counselor, and brief advice (BA), on reducing preconception substance-exposed pregnancy risk (i.e. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Prenatal Alcohol Exposure, Prenatal Tobacco Exposure, Prenatal Marijuana Exposure
- What is being tested?
- Computer tablet-delivered C4H, Person-delivered C4H and Brief Advice
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 219 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jun 2018to 31 Dec 2020
- 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 18 to 44 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- are 18-44 years old;
- have no condition causing infertility (e.g., tubal ligation, hysterectomy, menopause);
- are not pregnant or planning to become pregnant in the next 12 months;
- are available for the follow-up period;
- had vaginal intercourse during the previous 30 days with a fertile man and did not use effective contraception every time AND are drinking at risk levels (more than 3 drinks/day or more than 7 drinks/week); OR are reporting marijuana use in the previous month, OR are currently smoking cigarettes (at least weekly use) during the 30-day baseline period.
Who cannot join
- have severe cognitive, and/or psychiatric impairment that precludes cooperation with study protocol, per judgment of the C4H interventionist or research staff;
- are unable to read, write, and speak English or Spanish;
- are unable or unwilling to meet study requirements, including followup assessments.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tablet-based Intervention to Prevent Substance-exposed Pregnancy in Primary Care
This is a 4-year randomized, controlled study to test the efficacy of the CHOICES4Health-T (C4H-T) delivered by a computerized tablet, CHOICES4Health-C (C4H-C), delivered by a counselor, and brief advice (BA), on reducing preconception substance-exposed pregnancy risk (i.e. drinking below risk levels; tobacco and marijuana cessation; effective contraception use) among women (aged 18-44) presenting to the 13 primary care clinics that serve adults within the Harris Health System. Given the natural fit between contraceptive and HIV prevention counseling the CHOICES4Health interventions will also target HIV sexual risk behaviors.
Read the detailed description
A randomized group design (N = 240) will be used to test the efficacy of the C4H-C and C4H-T interventions relative to Brief Advice (BA) to reduce the risk of substance-exposed pregnancy) SEP in preconception women of childbearing age. Follow-up assessments will be conducted at 3, 6, and 9 months.
Each of the substances targeted in this study (risk drinking, cigarette smoking, and marijuana use) is commonly used relative to other substances and is singly or jointly associated with risk for poor fetal outcomes. Thus, women who are not using effective contraception (i.e., use of effective birth-control methods during all vaginal intercourse) and have any one or more substance-risk behaviors in the 30 days before intake will be eligible for the study.
Urn randomization will be used to stratify women on all three substance-risk behaviors to ensure a balanced number of women presenting with alcohol-exposed pregnancy (AEP), tobacco-exposed pregnancy (TEP), and marijuana-exposed pregnancy (MEP) risks across the three study conditions. To address risk distribution for women who present with more than one risk behavior the urn randomization will also be programmed to balance single risk and multiple risk women across the study conditions. In sum, the urn randomization will include four assignment criteria: AEP, TEP, MEP, and multiple risks. Finally, different numbers of women will be needed for each type of substance-exposed pregnancy risk in order to provide sufficient power for the investigator's analytic tests. For example, approximately 25% more women at risk of AEP are required than for TEP to attain the same power. The investigators will include over sampling rules and stopping rules to ensure adequate recruitment for AEP, TEP, and MEP.
- Being tested
- Computer tablet-delivered C4H, Person-delivered C4H, Brief Advice
- Keywords
- prenatal alcohol exposure, marijuana, smoking cessation, computer-delivered intervention, contraception, behavioral intervention, motivational interviewing
- Medical subject headings
- Marijuana Abuse, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer tablet-delivered C4HBehavioural
Also called C4H-T
Two session CHOICES intervention targeting ineffective contraception and risky alcohol use and/or cigarette smoking and/or marijuana use to reduce the risk of a substance-exposed pregnancy delivered on a computer-tablet.
Person-delivered C4HBehavioural
Also called C4H-C
Two session CHOICES intervention targeting ineffective contraception and risky alcohol use and/or cigarette smoking and/or marijuana use to reduce the risk of a substance-exposed pregnancy delivered by a counselor.
Brief AdviceBehavioural
Also called BA
Brief advice delivered by a research associate about healthy behaviors for women including use of contraception and alcohol, tobacco, and marijuana use
| Study group | Role | What they receive |
|---|---|---|
| Computer tablet-delivered C4H | Experimental | Two session CHOICES4Health intervention delivered by a computer tablet to address no use or ineffective use of contraception, and risky alcohol use, or cigarette smoking, or marijuana use. Receives: Behavioral: Computer tablet-delivered C4H |
| Person-delivered C4H | Experimental | Two session CHOICES4Health intervention delivered by a counselor to address no use or ineffective use of contraception, and risky alcohol use, or cigarette smoking, or marijuana use. Receives: Behavioral: Person-delivered C4H |
| Brief Advice | Active comparator | Women will receive advice and educational material from a research assistant about risk drinking, smoking, marijuana, and contraception, depending on their specific risk behaviors, as well as information about women's health. In addition, the women will receive referrals to the Harris Health System's SBIRT clinic if needed. Receives: Behavioral: Brief Advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in risk of alcohol-exposed pregnancy (AEP) as measured by self-reported daily standard drinks, vaginal sex, and use of contraception on the Timeline Followback calendar.
Risk of AEP is defined as any risk drinking (>3 drinks/day or >7 drinks/week on average) and any occurrence of vaginal sex with no use or ineffective use of contraception in the assessment period. Self-reported daily alcohol use (in standard drinks), vaginal intercourse, and contraception (effective use) data from the Timeline Followback will be used to calculate risk of AEP for the previous 90 days. Change in Risk of AEP will be examined at 3-, 6-, and 9-months post-intake. A participant will be considered at risk of AEP at each of the 3-, 6-, and 9 month timepoints if the participant had any occurrence of vaginal sex without the use of effective contraception and had more than 3 standard drinks on any day or more than 7 standard drinks per week on average in any 30 day period in the previous 90 days. Risk of AEP will be a dichotomous outcome (at risk of AEP or at reduced risk of AEP).
Measured: 3, 6, and 9 months
Change in risk of tobacco-exposed pregnancy (TEP) as measured by self-reported daily number of cigarettes, vaginal sex, and use of contraception on the Timeline Followback calendar.
Risk of TEP is defined as currently smoking cigarettes (at least weekly use) and any occurrence of vaginal sex with no use or ineffective use of contraception in the assessment period. Self-reported data from the Timeline Followback will be used to calculate risk of TEP for the previous 90 days at 3-, 6 , and 9 months post-intake. A participant will be considered at risk of TEP at each of the 3-, 6-, and 9 month timepoints if the participant had any occurrence of vaginal sex without the use of effective contraception and she had at least weekly smoking in any 30 day period in the previous 90 days. Risk of TEP will be a dichotomous outcome (at risk of TEP or at reduced risk of TEP).
Measured: 3, 6, and 9 months
Change in risk of marijuana-exposed pregnancy (MEP) as measured by self-reported marijuana use, vaginal sex, and use of contraception on the Timeline Followback calendar.
Risk of MEP is defined as any day with marijuana use and any occurrence of vaginal sex with no use or ineffective use of contraception in the assessment period. Self-reported data from the Timeline Followback will be used to calculate risk of MEP for the previous 90 days at 3-, 6- , and 9 months post-intake. A participant will be considered at risk of MEP at each of the 3-, 6-, and 9 month timepoints if the participant had any occurrence of vaginal sex without the use of effective contraception and had any day with marijuana use in any 30 day period in the previous 90 days. Risk of MEP will be a dichotomous outcome (at risk of MEP or at reduced risk of MEP).
Measured: 3, 6, and 9 months
Change in risk drinking as measured by self-reported number of standard drinks on the Timeline Followback calendar.
Risk drinking is defined as drinking more than 3 standard drinks on any day or drinking more than 7 standard drinks in a week on average in the previous 90 days. Self-reported data from the Timeline Followback will be used to calculate risk drinking for the previous 90 days at 3-, 6-, and 9-months post-intake. Risk drinking will be a dichotomous outcome (yes or no).
Measured: 3, 6, and 9 months
Change in cigarette smoking as measured by self-reported number of cigarettes smoked each day on the Timeline Followback calendar.
Cigarette smoking is defined as at least weekly cigarette smoking in the previous 90 days on the Timeline Followback calendar at 3-, 6-, and 9-months post-intake. Cigarette smoking will be a dichotomous outcome (yes or no). In addition, smoking will be validated using biological test to assess cotinine levels.
Measured: 3, 6, and 9 months
Change in marijuana use as measured by self-reported use for each day on the Timeline Followback calendar.
Marijuana use is defined as any day with any marijuana use in the previous 90 days on the Timeline Followback calendar at 3-, 6-, and 9-months post-intake. Marijuana use will be a dichotomous outcome (yes or no). In addition, marijuana use will be validated using a biological test to assess Tetrahydrocannabinol (THC) levels.
Measured: 3, 6, and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2018
- Study start28 Jun 2018
- Primary completion18 Nov 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prenatal Alcohol ExposureStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Collaborators
- Baylor College of Medicine, The University of Texas Health Science Center, Houston, University of Houston
- Responsible party
- Sponsor
- Investigators
- Mary M Velasquez, Ph.D., Principal investigator, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03633149
- Sponsor's protocol ID
- R01AA022924
- Acronym
- C4H
- Status last verified
- May 2022
- First submitted
- 11 May 2016
- Last updated
- 2 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tablet-based Intervention to Prevent Substance-exposed Pregnancy in Primary Care
- ClinicalTrials.gov ID
- NCT03633149
- Acronym / sponsor ID
- C4H / R01AA022924
- Keywords
- prenatal alcohol exposure, marijuana, smoking cessation, computer-delivered intervention, contraception, behavioral intervention, motivational interviewing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 219 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Collaborators
- Baylor College of Medicine, The University of Texas Health Science Center, Houston, University of Houston
- Study start
- 28 Jun 2018 (actual)
- Primary completion
- 18 Nov 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 16 Aug 2018 (actual)
- 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 is a 4-year randomized, controlled study to test the efficacy of the CHOICES4Health-T (C4H-T) delivered by a computerized tablet, CHOICES4Health-C (C4H-C), delivered by a counselor, and brief advice (BA), on reducing preconception substance-exposed pregnancy risk (i.e. drinking below risk levels; tobacco and marijuana cessation; effective contraception use) among women (aged 18-44) presenting to the 13 primary care clinics that serve adults within the Harris Health System. Given the natural fit between contraceptive and HIV prevention counseling the CHOICES4Health interventions will also target HIV sexual risk behaviors.
Detailed description
A randomized group design (N = 240) will be used to test the efficacy of the C4H-C and C4H-T interventions relative to Brief Advice (BA) to reduce the risk of substance-exposed pregnancy) SEP in preconception women of childbearing age. Follow-up assessments will be conducted at 3, 6, and 9 months.
Each of the substances targeted in this study (risk drinking, cigarette smoking, and marijuana use) is commonly used relative to other substances and is singly or jointly associated with risk for poor fetal outcomes. Thus, women who are not using effective contraception (i.e., use of effective birth-control methods during all vaginal intercourse) and have any one or more substance-risk behaviors in the 30 days before intake will be eligible for the study.
Urn randomization will be used to stratify women on all three substance-risk behaviors to ensure a balanced number of women presenting with alcohol-exposed pregnancy (AEP), tobacco-exposed pregnancy (TEP), and marijuana-exposed pregnancy (MEP) risks across the three study conditions. To address risk distribution for women who present with more than one risk behavior the urn randomization will also be programmed to balance single risk and multiple risk women across the study conditions. In sum, the urn randomization will include four assignment criteria: AEP, TEP, MEP, and multiple risks. Finally, different numbers of women will be needed for each type of substance-exposed pregnancy risk in order to provide sufficient power for the investigator's analytic tests. For example, approximately 25% more women at risk of AEP are required than for TEP to attain the same power. The investigators will include over sampling rules and stopping rules to ensure adequate recruitment for AEP, TEP, and MEP.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Computer tablet-delivered C4H | Experimental | Behavioral: Computer tablet-delivered C4HTwo session CHOICES4Health intervention delivered by a computer tablet to address no use or ineffective use of contraception, and risky alcohol use, or cigarette smoking, or marijuana use. |
| Person-delivered C4H | Experimental | Behavioral: Person-delivered C4HTwo session CHOICES4Health intervention delivered by a counselor to address no use or ineffective use of contraception, and risky alcohol use, or cigarette smoking, or marijuana use. |
| Brief Advice | Active comparator | Behavioral: Brief AdviceWomen will receive advice and educational material from a research assistant about risk drinking, smoking, marijuana, and contraception, depending on their specific risk behaviors, as well as information about women's health. In addition, the women will receive referrals to the Harris Health System's SBIRT clinic if needed. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- are 18-44 years old;
- have no condition causing infertility (e.g., tubal ligation, hysterectomy, menopause);
- are not pregnant or planning to become pregnant in the next 12 months;
- are available for the follow-up period;
- had vaginal intercourse during the previous 30 days with a fertile man and did not use effective contraception every time AND are drinking at risk levels (more than 3 drinks/day or more than 7 drinks/week); OR are reporting marijuana use in the previous month, OR are currently smoking cigarettes (at least weekly use) during the 30-day baseline period.
Key exclusion criteria (3 listed)
- have severe cognitive, and/or psychiatric impairment that precludes cooperation with study protocol, per judgment of the C4H interventionist or research staff;
- are unable to read, write, and speak English or Spanish;
- are unable or unwilling to meet study requirements, including followup assessments.
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 |
|---|---|---|
| Computer tablet-delivered C4HAlso: C4H-TTwo session CHOICES intervention targeting ineffective contraception and risky alcohol use and/or cigarette smoking and/or marijuana use to reduce the risk of a substance-exposed pregnancy delivered on a computer-tablet. | Behavioural | Computer tablet-delivered C4H |
| Person-delivered C4HAlso: C4H-CTwo session CHOICES intervention targeting ineffective contraception and risky alcohol use and/or cigarette smoking and/or marijuana use to reduce the risk of a substance-exposed pregnancy delivered by a counselor. | Behavioural | Person-delivered C4H |
| Brief AdviceAlso: BABrief advice delivered by a research associate about healthy behaviors for women including use of contraception and alcohol, tobacco, and marijuana use | Behavioural | Brief Advice |
Primary outcome
Change in risk of alcohol-exposed pregnancy (AEP) as measured by self-reported daily standard drinks, vaginal sex, and use of contraception on the Timeline Followback calendar.
Time frame: 3, 6, and 9 months
Risk of AEP is defined as any risk drinking (>3 drinks/day or >7 drinks/week on average) and any occurrence of vaginal sex with no use or ineffective use of contraception in the assessment period. Self-reported daily alcohol use (in standard drinks), vaginal intercourse, and contraception (effective use) data from the Timeline Followback will be used to calculate risk of AEP for the previous 90 days. Change in Risk of AEP will be examined at 3-, 6-, and 9-months post-intake. A participant will be considered at risk of AEP at each of the 3-, 6-, and 9 month timepoints if the participant had any occurrence of vaginal sex without the use of effective contraception and had more than 3 standard drinks on any day or more than 7 standard drinks per week on average in any 30 day period in the previous 90 days. Risk of AEP will be a dichotomous outcome (at risk of AEP or at reduced risk of AEP).
Change in risk of tobacco-exposed pregnancy (TEP) as measured by self-reported daily number of cigarettes, vaginal sex, and use of contraception on the Timeline Followback calendar.
Time frame: 3, 6, and 9 months
Risk of TEP is defined as currently smoking cigarettes (at least weekly use) and any occurrence of vaginal sex with no use or ineffective use of contraception in the assessment period. Self-reported data from the Timeline Followback will be used to calculate risk of TEP for the previous 90 days at 3-, 6 , and 9 months post-intake. A participant will be considered at risk of TEP at each of the 3-, 6-, and 9 month timepoints if the participant had any occurrence of vaginal sex without the use of effective contraception and she had at least weekly smoking in any 30 day period in the previous 90 days. Risk of TEP will be a dichotomous outcome (at risk of TEP or at reduced risk of TEP).
Change in risk of marijuana-exposed pregnancy (MEP) as measured by self-reported marijuana use, vaginal sex, and use of contraception on the Timeline Followback calendar.
Time frame: 3, 6, and 9 months
Risk of MEP is defined as any day with marijuana use and any occurrence of vaginal sex with no use or ineffective use of contraception in the assessment period. Self-reported data from the Timeline Followback will be used to calculate risk of MEP for the previous 90 days at 3-, 6- , and 9 months post-intake. A participant will be considered at risk of MEP at each of the 3-, 6-, and 9 month timepoints if the participant had any occurrence of vaginal sex without the use of effective contraception and had any day with marijuana use in any 30 day period in the previous 90 days. Risk of MEP will be a dichotomous outcome (at risk of MEP or at reduced risk of MEP).
Change in risk drinking as measured by self-reported number of standard drinks on the Timeline Followback calendar.
Time frame: 3, 6, and 9 months
Risk drinking is defined as drinking more than 3 standard drinks on any day or drinking more than 7 standard drinks in a week on average in the previous 90 days. Self-reported data from the Timeline Followback will be used to calculate risk drinking for the previous 90 days at 3-, 6-, and 9-months post-intake. Risk drinking will be a dichotomous outcome (yes or no).
Change in cigarette smoking as measured by self-reported number of cigarettes smoked each day on the Timeline Followback calendar.
Time frame: 3, 6, and 9 months
Cigarette smoking is defined as at least weekly cigarette smoking in the previous 90 days on the Timeline Followback calendar at 3-, 6-, and 9-months post-intake. Cigarette smoking will be a dichotomous outcome (yes or no). In addition, smoking will be validated using biological test to assess cotinine levels.
Change in marijuana use as measured by self-reported use for each day on the Timeline Followback calendar.
Time frame: 3, 6, and 9 months
Marijuana use is defined as any day with any marijuana use in the previous 90 days on the Timeline Followback calendar at 3-, 6-, and 9-months post-intake. Marijuana use will be a dichotomous outcome (yes or no). In addition, marijuana use will be validated using a biological test to assess Tetrahydrocannabinol (THC) levels.
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 2 Jun 2022.
- Health Behavior Research and Training Institute, University of Texas at AustinLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Mary M Velasquez, Ph.D. principal investigator
University of Texas at Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer tablet-delivered C4H, Person-delivered C4H and Brief Advice in people with Prenatal Alcohol Exposure and Prenatal Tobacco Exposure, run by University of Texas at Austin at 1 site in United States.
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 5 inclusion and 3 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 2 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Change in risk of alcohol-exposed pregnancy (AEP) as measured by self-reported daily standard drinks, vaginal sex, and use of contraception on the Timeline Followback calendar. (time frame: 3, 6, and 9 months). The study lists 6 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 2 Jun 2022.