Substance Use DisordersNCT03165565
Facilitating Treatment Entry and Family Planning in Substance-using Neonatal Intensive Care Unit (NICU) Mothers
A study testing Motivational Interviewing (MI) and Acceptance and Commitment Therapy (ACT) and Conventional Care in people with Substance Use Disorders, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this pilot study is to assess whether the hospital-based, adaptive behavioral intervention strategy promotes treatment entry and reduces risk of additional substance-exposed pregnancies (SEPs), as well as HIV and Hepatitis C Virus (HCV) risks among substance-using NICU mothers. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Substance Use Disorders
- What is being tested?
- Motivational Interviewing (MI) and Acceptance and Commitment Therapy (ACT) and Conventional Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jul 2017to 3 Jan 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- have an infant in the NICU at Children's Memorial Hermann Hospital (CMHH)
- have a positive urine drug screen at delivery or have an infant with a positive urine or meconium drug screen or self-reported drug use to a healthcare provider or had a documented positive drug screen during pregnancy
- have access to a telephone.
Who cannot join
- currently attending substance abuse treatment
- severe cognitive, and/or psychiatric impairment, per judgment of NICU and research staff, that precludes cooperation with study protocol
- inability to read, write, speak English or Spanish
- inability or unwillingness to provide signed consent for participation; (5) inability or unwillingness to meet study requirements.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: Facilitating Treatment Entry and Family Planning in Substance-using NICU Mothers
The purpose of this pilot study is to assess whether the hospital-based, adaptive behavioral intervention strategy promotes treatment entry and reduces risk of additional substance-exposed pregnancies (SEPs), as well as HIV and Hepatitis C Virus (HCV) risks among substance-using NICU mothers. Additionally, to assess whether the intervention increases use of professional obstetrical/gynecological resources for contraception to reduce substance-exposed pregnancies (SEPs).
- Conditions
- Substance Use Disorders
- Being tested
- Motivational Interviewing (MI) and Acceptance and Commitment Therapy (ACT), Conventional Care
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational Interviewing (MI) and Acceptance and Commitment Therapy (ACT)Behavioural
Participants will receive Motivational Interviewing (MI) and Acceptance and Commitment Therapy (ACT).
Conventional CareBehavioural
Conventional care from the hospital for NICU mothers who test positive for drug use, which includes visits and resources from hospital social workers.
| Study group | Role | What they receive |
|---|---|---|
| MI and ACT | Experimental | Participants will receive behavioral therapy including Motivational Interviewing (MI) and Acceptance and Commitment Therapy (ACT). Receives: Behavioral: Motivational Interviewing (MI) and Acceptance and Commitment Therapy (ACT) |
| Conventional Care | Active comparator | Conventional care from the hospital for NICU mothers who test positive for drug use, which includes visits and resources from hospital social workers. Receives: Behavioral: Conventional Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Entry
Number of participants having at least one treatment session at a licensed substance use facility or with a licensed counselor
Measured: 8 weeks
Substance Exposed Pregnancy (SEP) risk as as assessed by a modified Time-Line Follow Back-SEP (TLFB-SEP)
Substance Exposed Pregnancy (SEP) risk as as assessed by a modified Time-Line Follow Back-SEP (TLFB-SEP)
Measured: 2 months
Substance Exposed Pregnancy (SEP) risk as as assessed by a modified Time-Line Follow Back-SEP (TLFB-SEP)
Substance Exposed Pregnancy (SEP) risk as as assessed by a modified Time-Line Follow Back-SEP (TLFB-SEP)
Measured: 6 months
HIV and HCV risk as assessed by Behavioral Risk Assessment for Infectious Disease (BRAID)
HIV and HCV risk as assessed by Behavioral Risk Assessment for Infectious Disease (BRAID)
Measured: 2 months
HIV and HCV risk as assessed by Behavioral Risk Assessment for Infectious Disease (BRAID)
HIV and HCV risk as assessed by Behavioral Risk Assessment for Infectious Disease (BRAID)
Measured: 6 months
Secondary outcomes (14)
Depression as assessed by the Center for Epidemiologic Studies Depression Scale (CES-D)
Depression as assessed by the Center for Epidemiologic Studies Depression Scale (CES-D)
Measured: 2 months
Depression as assessed by the Center for Epidemiologic Studies Depression Scale (CES-D)
Depression as assessed by the Center for Epidemiologic Studies Depression Scale (CES-D)
Measured: 6 months
Current position regarding motivation for change as assessed by the University of Rhode Island Change Assessment (URICA)
Current position regarding motivation for change as assessed by the University of Rhode Island Change Assessment (URICA)
Measured: 2 months
Current position regarding motivation for change as assessed by the University of Rhode Island Change Assessment (URICA)
Current position regarding motivation for change as assessed by the University of Rhode Island Change Assessment (URICA)
Measured: 6 months
Psychological flexibility as assessed by the Acceptance and Action Questionnaire-Substance Abuse (AAQ-SA)
This self-report measure of psychological flexibility will assess a participant's willingness to have undesirable thoughts and feelings related to drug use while still pursuing self-identified goals. This version of the AAQ was specifically developed for substance-abusing populations.
Measured: 2 months
Psychological flexibility as assessed by the Acceptance and Action Questionnaire-Substance Abuse (AAQ-SA)
This self-report measure of psychological flexibility will assess a participant's willingness to have undesirable thoughts and feelings related to drug use while still pursuing self-identified goals. This version of the AAQ was specifically developed for substance-abusing populations.
Measured: 6 months
Number of participants whose infant had routine follow-up pediatric appointments
Medical records will be used, with participant consent, to assess the number of participants whose infant had routine follow-up pediatric appointments.
Measured: 6 months
Number of participants whose infant had acute care visits
Medical records will be used, with participant consent, to assess the number of participants whose infant had acute care visits.
Measured: 6 months
Number of participants whose infant had emergency department visits
Medical records will be used, with participant consent, to assess the number of participants whose infant had emergency department visits.
Measured: 6 months
Number of participants whose infant was re-hospitalized
Medical records will be used, with participant consent, to assess the number of participants whose infant was re-hospitalized.
Measured: 6 months
Number of participants who lost custody of the infant
Medical records will be used, with participant consent, and additionally the research team will collaborate with the NICU social worker and the assigned child protective services (CPS) caseworker, with participant consent, to obtain information about the number of participants who lost custody of the infant.
Measured: 6 months
Number of participants for which any additional abuse or neglect complaints were filed after baseline
Medical records will be used, with participant consent, and additionally the research team will collaborate with the NICU social worker and the assigned child protective services (CPS) caseworker, with participant consent, to obtain information about the number of participants for which any additional abuse or neglect complaints were filed after baseline.
Measured: 6 months
Drug use
Number of participant who test positive for drug use as assessed by urine drug screen
Measured: 2 months
Drug use
Number of participant who test positive for drug use as assessed by urine drug screen
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2017
- Study start5 Jul 2017
- Primary completion3 Jan 2020
- Study completion3 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Angela L Stotts, The University of Texas Health Science Center, Houston
- Investigators
- Angela Stotts, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03165565
- Sponsor's protocol ID
- HSC-MS-15-0990
- Other IDs
- R34DA041465
- Status last verified
- Nov 2020
- First submitted
- 23 May 2017
- Last updated
- 19 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facilitating Treatment Entry and Family Planning in Substance-using NICU Mothers
- ClinicalTrials.gov ID
- NCT03165565
- Acronym / sponsor ID
- HSC-MS-15-0990
- Conditions
- Substance Use Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 5 Jul 2017 (actual)
- Primary completion
- 3 Jan 2020 (actual)
- Study completion
- 3 Jan 2020 (actual)
- First posted
- 24 May 2017 (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.
The purpose of this pilot study is to assess whether the hospital-based, adaptive behavioral intervention strategy promotes treatment entry and reduces risk of additional substance-exposed pregnancies (SEPs), as well as HIV and Hepatitis C Virus (HCV) risks among substance-using NICU mothers. Additionally, to assess whether the intervention increases use of professional obstetrical/gynecological resources for contraception to reduce substance-exposed pregnancies (SEPs).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MI and ACT | Experimental | Behavioral: Motivational Interviewing (MI) and Acceptance and Commitment Therapy (ACT)Participants will receive behavioral therapy including Motivational Interviewing (MI) and Acceptance and Commitment Therapy (ACT). |
| Conventional Care | Active comparator | Behavioral: Conventional CareConventional care from the hospital for NICU mothers who test positive for drug use, which includes visits and resources from hospital social workers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- have an infant in the NICU at Children's Memorial Hermann Hospital (CMHH)
- have a positive urine drug screen at delivery or have an infant with a positive urine or meconium drug screen or self-reported drug use to a healthcare provider or had a documented positive drug screen during pregnancy
- have access to a telephone.
Key exclusion criteria (4 listed)
- currently attending substance abuse treatment
- severe cognitive, and/or psychiatric impairment, per judgment of NICU and research staff, that precludes cooperation with study protocol
- inability to read, write, speak English or Spanish
- inability or unwillingness to provide signed consent for participation; (5) inability or unwillingness to meet study requirements.
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 |
|---|---|---|
| Motivational Interviewing (MI) and Acceptance and Commitment Therapy (ACT)Participants will receive Motivational Interviewing (MI) and Acceptance and Commitment Therapy (ACT). | Behavioural | MI and ACT |
| Conventional CareConventional care from the hospital for NICU mothers who test positive for drug use, which includes visits and resources from hospital social workers. | Behavioural | Conventional Care |
Primary outcome
Treatment Entry
Time frame: 8 weeks
Number of participants having at least one treatment session at a licensed substance use facility or with a licensed counselor
Substance Exposed Pregnancy (SEP) risk as as assessed by a modified Time-Line Follow Back-SEP (TLFB-SEP)
Time frame: 2 months
Substance Exposed Pregnancy (SEP) risk as as assessed by a modified Time-Line Follow Back-SEP (TLFB-SEP)
Substance Exposed Pregnancy (SEP) risk as as assessed by a modified Time-Line Follow Back-SEP (TLFB-SEP)
Time frame: 6 months
Substance Exposed Pregnancy (SEP) risk as as assessed by a modified Time-Line Follow Back-SEP (TLFB-SEP)
HIV and HCV risk as assessed by Behavioral Risk Assessment for Infectious Disease (BRAID)
Time frame: 2 months
HIV and HCV risk as assessed by Behavioral Risk Assessment for Infectious Disease (BRAID)
HIV and HCV risk as assessed by Behavioral Risk Assessment for Infectious Disease (BRAID)
Time frame: 6 months
HIV and HCV risk as assessed by Behavioral Risk Assessment for Infectious Disease (BRAID)
14 secondary outcomes
Depression as assessed by the Center for Epidemiologic Studies Depression Scale (CES-D)
Time frame: 2 months
Depression as assessed by the Center for Epidemiologic Studies Depression Scale (CES-D)
Time frame: 6 months
Current position regarding motivation for change as assessed by the University of Rhode Island Change Assessment (URICA)
Time frame: 2 months
Current position regarding motivation for change as assessed by the University of Rhode Island Change Assessment (URICA)
Time frame: 6 months
Psychological flexibility as assessed by the Acceptance and Action Questionnaire-Substance Abuse (AAQ-SA)
Time frame: 2 months
Psychological flexibility as assessed by the Acceptance and Action Questionnaire-Substance Abuse (AAQ-SA)
Time frame: 6 months
Number of participants whose infant had routine follow-up pediatric appointments
Time frame: 6 months
Number of participants whose infant had acute care visits
Time frame: 6 months
Number of participants whose infant had emergency department visits
Time frame: 6 months
Number of participants whose infant was re-hospitalized
Time frame: 6 months
Number of participants who lost custody of the infant
Time frame: 6 months
Number of participants for which any additional abuse or neglect complaints were filed after baseline
Time frame: 6 months
Drug use
Time frame: 2 months
Drug use
Time frame: 6 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 19 Nov 2020.
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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.
Angela Stotts, PhD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interviewing (MI) and Acceptance and Commitment Therapy (ACT) and Conventional Care in people with Substance Use Disorders, run by The University of Texas Health Science Center, Houston 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 3 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 19 Nov 2020. 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?
Treatment Entry (time frame: 8 weeks). The study lists 5 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 19 Nov 2020.