Drug AbusePhase 2NCT01650675
Indirect Assessment and Intervention for Perinatal Drug Use
A Phase 2 study testing WIDUS computer-delivered, indirect brief intervention in people with Drug Abuse, run by Wayne State University at 1 site in United States.
Trial summary
The purpose of this study is to assess the validity of an indirect computer-delivered screener for drug use and assess the efficacy of a computer-delivered brief intervention with urban post-partum women at-risk for substance abuse and HIV during the post-partum period. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Drug Abuse
- What is being tested?
- WIDUS computer-delivered, indirect brief intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to May 2015
- Phase
- Phase 2
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 18 years of age or older
- able to communicate in English
- recently gave birth to healthy infant
Who cannot join
- received narcotic pain medication in past 3 hours
- no sleep since giving birth
- infant deceased or in intensive care
- psychosis or other clear cognitive impairment
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to assess the validity of an indirect computer-delivered screener for drug use and assess the efficacy of a computer-delivered brief intervention with urban post-partum women at-risk for substance abuse and HIV during the post-partum period.
Read the detailed description
Two factors limit the potential of brief interventions for the reduction of substance abuse and HIV risk. First, the ability to conduct such interventions is dependent upon willingness to disclose drug use and risky sexual behaviors. This is a significant obstacle given evidence that as few as half of drug-positive individuals-particularly women in the perinatal period-report that use. Second, there are logistic and financial obstacles to implementing even brief intervention programs, particularly with regard to time, training and provider willingness. In response to these limitations, and with NIDA support (DA018975), the Parent Health Lab at the Wayne State University School of Medicine developed and validated a sensitive indirect screener that evaluates correlates of illicit drug use rather than drug use itself. The Lab also developed a brief computer-delivered intervention designed to build change motivation without presuming the presence of risks to accompany the screener. This intervention demonstrated excellent feasibility and acceptability in Phase I testing. Following NIDA's Stage Model of Behavioral Therapy Development, the proposed study will take the next step of validating the computer-delivered indirect screening and intervention process in a Phase II/Stage IIb trial with women determined to be at risk by the indirect drug use screener. In addition, given that 47.8% of the prior sample's participants had an STI at some point in their lives, the proposed study will also further expand the existing focus on HIV risk. Specifically, we plan to: (a) continue development and validation of the WIDUS screener via concomitant collection of WIDUS protocols and hair/urine samples, as well as by building its ability to indirectly predict HIV risk; (b) revise and upgrade the draft indirect intervention based on expert and participant informant feedback; (c) recruit 500 at-risk women from an urban obstetric hospital; and (d) randomly assign participants into intervention and control conditions, with blinded follow-up assessments at 3- and 6-months. If proven efficacious, this logistically feasible, replicable, and low-cost approach could allow a dramatic increase in the reach--and therefore the population impact--of brief interventions for drug use among at-risk post-partum women. Further, any impact on maternal drug use would be further multiplied by indirect effects on the at-risk child.
- Conditions
- Drug Abuse
- Being tested
- WIDUS computer-delivered, indirect brief intervention, Nutrition time control/placebo intervention
- Keywords
- pregnancy, screening, motivation
- 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.
WIDUS computer-delivered, indirect brief interventionBehavioural
A single 20-minute interactive computer-delivered intervention designed to promote motivation to change drug use and risky sexual behavior, if any, without presuming those risks to be specifically present.
Nutrition time control/placebo interventionBehavioural
This time-control intervention, designed in part to help promote RA blinding as to participant condition, focuses on proper infant nutrition using a computer-delivered, interactive format and videos.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Participants randomized into the control condition complete assessment and a time-matched interactive session on infant nutrition. Receives: Behavioral: Nutrition time control/placebo intervention |
| Indirect intervention | Experimental | Participants in this condition review a short series of parenting strengths that benefit infants, and are invited to consider their current status in each area. This list includes factors associated with drug use (e.g., safety, emotional health) as well as substance use itself. Receives: Behavioral: WIDUS computer-delivered, indirect brief intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of drug using days
Drug use over past 90 days will be measured at a 3 and 6-month follow-up by self-report, hair, and urine analysis.
Measured: since last research visit; up to 90 days prior to current evaluation
Change from Baseline HIV and other STI risk at 3 months
Self-report of risky sexual and/or injection drug use that could place participants at risk of HIV and other STIs
Measured: since last research visit; up to 90 days from baseline visit
Change from Baseline in HIV and Other STI Risk at 6 months
Self-report of risky sexual and/or injection drug use that could place participants at risk of HIV and other STIs
Measured: since last research visit; up to 180 days since baseline visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2012 (estimated)
- Study startJun 2012
- Primary completionNov 2014
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug AbuseStudies 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 2
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Steven J. Ondersma, Wayne State University
- Investigators
- Steven J Ondersma, Ph.D., Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01650675
- Sponsor's protocol ID
- R01DA029050
- Other IDs
- R01DA029050
- Status last verified
- Dec 2015
- First submitted
- 13 Jul 2012
- Last updated
- 8 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Indirect Assessment and Intervention for Perinatal Drug Use
- ClinicalTrials.gov ID
- NCT01650675
- Acronym / sponsor ID
- R01DA029050
- Conditions
- Drug Abuse
- Keywords
- pregnancy, screening, motivation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jun 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 26 Jul 2012 (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.
The purpose of this study is to assess the validity of an indirect computer-delivered screener for drug use and assess the efficacy of a computer-delivered brief intervention with urban post-partum women at-risk for substance abuse and HIV during the post-partum period.
Detailed description
Two factors limit the potential of brief interventions for the reduction of substance abuse and HIV risk. First, the ability to conduct such interventions is dependent upon willingness to disclose drug use and risky sexual behaviors. This is a significant obstacle given evidence that as few as half of drug-positive individuals-particularly women in the perinatal period-report that use. Second, there are logistic and financial obstacles to implementing even brief intervention programs, particularly with regard to time, training and provider willingness. In response to these limitations, and with NIDA support (DA018975), the Parent Health Lab at the Wayne State University School of Medicine developed and validated a sensitive indirect screener that evaluates correlates of illicit drug use rather than drug use itself. The Lab also developed a brief computer-delivered intervention designed to build change motivation without presuming the presence of risks to accompany the screener. This intervention demonstrated excellent feasibility and acceptability in Phase I testing. Following NIDA's Stage Model of Behavioral Therapy Development, the proposed study will take the next step of validating the computer-delivered indirect screening and intervention process in a Phase II/Stage IIb trial with women determined to be at risk by the indirect drug use screener. In addition, given that 47.8% of the prior sample's participants had an STI at some point in their lives, the proposed study will also further expand the existing focus on HIV risk. Specifically, we plan to: (a) continue development and validation of the WIDUS screener via concomitant collection of WIDUS protocols and hair/urine samples, as well as by building its ability to indirectly predict HIV risk; (b) revise and upgrade the draft indirect intervention based on expert and participant informant feedback; (c) recruit 500 at-risk women from an urban obstetric hospital; and (d) randomly assign participants into intervention and control conditions, with blinded follow-up assessments at 3- and 6-months. If proven efficacious, this logistically feasible, replicable, and low-cost approach could allow a dramatic increase in the reach--and therefore the population impact--of brief interventions for drug use among at-risk post-partum women. Further, any impact on maternal drug use would be further multiplied by indirect effects on the at-risk child.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Behavioral: Nutrition time control/placebo interventionParticipants randomized into the control condition complete assessment and a time-matched interactive session on infant nutrition. |
| Indirect intervention | Experimental | Behavioral: WIDUS computer-delivered, indirect brief interventionParticipants in this condition review a short series of parenting strengths that benefit infants, and are invited to consider their current status in each area. This list includes factors associated with drug use (e.g., safety, emotional health) as well as substance use itself. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18 years of age or older
- able to communicate in English
- recently gave birth to healthy infant
Key exclusion criteria (4 listed)
- received narcotic pain medication in past 3 hours
- no sleep since giving birth
- infant deceased or in intensive care
- psychosis or other clear cognitive impairment
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 |
|---|---|---|
| WIDUS computer-delivered, indirect brief interventionA single 20-minute interactive computer-delivered intervention designed to promote motivation to change drug use and risky sexual behavior, if any, without presuming those risks to be specifically present. | Behavioural | Indirect intervention |
| Nutrition time control/placebo interventionThis time-control intervention, designed in part to help promote RA blinding as to participant condition, focuses on proper infant nutrition using a computer-delivered, interactive format and videos. | Behavioural | Control |
Primary outcome
Number of drug using days
Time frame: since last research visit; up to 90 days prior to current evaluation
Drug use over past 90 days will be measured at a 3 and 6-month follow-up by self-report, hair, and urine analysis.
Change from Baseline HIV and other STI risk at 3 months
Time frame: since last research visit; up to 90 days from baseline visit
Self-report of risky sexual and/or injection drug use that could place participants at risk of HIV and other STIs
Change from Baseline in HIV and Other STI Risk at 6 months
Time frame: since last research visit; up to 180 days since baseline visit
Self-report of risky sexual and/or injection drug use that could place participants at risk of HIV and other STIs
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 8 Dec 2015.
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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.
Steven J Ondersma, Ph.D. principal investigator
Wayne State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing WIDUS computer-delivered, indirect brief intervention in people with Drug Abuse, run by Wayne State University 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 8 Dec 2015. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Number of drug using days (time frame: since last research visit; up to 90 days prior to current evaluation). 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 8 Dec 2015.