Substance UsePhase 1/2NCT00230009

Brief Intervention in At-Risk First-time Mothers

A Phase 1/2 study testing Brief motivational intervention in people with Substance Use, run by Wayne State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Preliminary controlled trial of a brief intervention designed to reduce child maltreatment risk among low-income pregnant mothers. Foci will include major risk factors for maltreatment, including substance abuse, social isolation, depression, violence exposure, and maladaptive child-rearing attitudes/beliefs. Read more about this study

Who is it for?: Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for: Substance Use
What is being tested?: Brief motivational intervention
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 1 siteUnited States
Study dates: Apr 2004to Mar 2007
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
Healthy volunteers accepted
Adult

Who may be able to join

Receipt of public assistance (e.g., Medicaid, Food Stamps), ability to communicate in English

Who cannot join

Frank psychosis or other cognitive impairment

Trial locations and contacts

1 site in 1 country.

United States1 site

Wayne State University
Detroit, Michigan, 48207

Other trials in United States

About this study

Conditions: Substance Use
Being tested: Brief motivational intervention
Keywords: child abuse, child neglect, substance use, violence exposure, brief intervention
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.

Brief motivational interventionBehavioural

Study groups in NCT00230009
Study group	Role	What they receive
Assessment only	No intervention	Not described
Brief intervention session	Experimental	Not described Receives: Behavioral: Brief motivational intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

Alcohol Use
Alcohol use was measured by looking at frequency of use in past 30 days with the Alcohol Use Disorders Identification Test (AUDIT), reported at the 3 month follow-up. The mean of each the control and intervention group was used. Frequency of use ranged from 0 to 5 for the follow-up sample. Higher scores mean more frequent use of the substance.
Measured: 3 month follow-up
Drug Use
Drug use was measured by looking at frequency of use in past 30 days with the Alcohol Use Disorders Identification Test (AUDIT), reported about marijuana use at the 3 month follow-up. The mean of each the assessment only and intervention group was used. Scores ranged from 0 to 13 for the follow-up sample. Higher scores mean more frequent use of the substance.
Measured: 3 month follow-up
Child Abuse Potential
Change score was calculated by taking the follow-up scores on the Brief Child Abuse Potential Inventory (BCAP) and subtracting the baseline score. The possible total score for the BCAP ranges from 0 to 24. Therefore, the possible range of scores for the change calculation (reported below) is -24 to +24. Higher scores indicate higher risk at the follow-up visit (worse outcome).
Measured: baseline and 3 month follow-up
Treatment Engagement
The number of participants who reported seeking outpatient substance abuse treatment since baseline (either at a treatment facility or through outpatient counseling).
Measured: at 3 month follow-up

Secondary outcomes (1)

Depression
Depression was measured by using the Center for Epidemiologic Studies Depression Scale (CES-D) at the 3 month follow-up. CES-D total scores can range from 0 to 60. Scores at 16 or higher indicate clinical significance. Higher scores represent higher risk for depression.
Measured: at 3 month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2004Mar 2007

First posted30 Sep 2005 (estimated)
Study startApr 2004
Primary completionMar 2007
Study completionMar 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Substance 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 1/2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00230009
Sponsor's protocol ID: NIDA-00516-3
Other IDs: K23DA000516
Status last verified: Aug 2013
First submitted: 29 Sep 2005
Last updated: 8 Aug 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Delaney-Black V, Covington C, Ondersma SJ, Nordstrom-Klee B, Templin T, Ager J, Janisse J, Sokol RJ. Violence exposure, trauma, and IQ and/or reading deficits among urban children. Arch Pediatr Adolesc Med. 2002 Mar;156(3):280-5. doi: 10.1001/archpedi.156.3.280.
PubMed 11876674
Ondersma SJ, Chaffin MJ, Mullins SM, LeBreton JM. A brief form of the child abuse potential inventory: development and validation. J Clin Child Adolesc Psychol. 2005 Jun;34(2):301-11. doi: 10.1207/s15374424jccp3402_9.
PubMed 15901230
Mullins SM, Bard DE, Ondersma SJ. Comprehensive services for mothers of drug-exposed infants: relations between program participation and subsequent child protective services reports. Child Maltreat. 2005 Feb;10(1):72-81. doi: 10.1177/1077559504272101.
PubMed 15611328
Mullins SM, Suarez M, Ondersma SJ, Page MC. The impact of motivational interviewing on substance abuse treatment retention: a randomized control trial of women involved with child welfare. J Subst Abuse Treat. 2004 Jul;27(1):51-8. doi: 10.1016/j.jsat.2004.03.010.
PubMed 15223094

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Substance Use trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Brief Intervention in At-Risk First-time Mothers
ClinicalTrials.gov ID: NCT00230009
Acronym / sponsor ID: NIDA-00516-3
Conditions: Substance Use
Keywords: child abuse, child neglect, substance use, violence exposure, brief intervention
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Wayne State UniversityUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: Apr 2004
Primary completion: Mar 2007 (actual)
Study completion: Mar 2007 (actual)
First posted: 30 Sep 2005 (estimated)
Results: Posted 8 Aug 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Assessment only	No intervention	–
Brief intervention session	Experimental	Behavioral: Brief motivational intervention

Who may qualify

Ages: 18 to 45 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

Receipt of public assistance (e.g., Medicaid, Food Stamps), ability to communicate in English

Key exclusion criteria (1 listed)

Frank psychosis or other 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
Brief motivational intervention	Behavioural	Brief intervention session

Primary outcome

Alcohol Use
Time frame: 3 month follow-up
Alcohol use was measured by looking at frequency of use in past 30 days with the Alcohol Use Disorders Identification Test (AUDIT), reported at the 3 month follow-up. The mean of each the control and intervention group was used. Frequency of use ranged from 0 to 5 for the follow-up sample. Higher scores mean more frequent use of the substance.
Drug Use
Time frame: 3 month follow-up
Drug use was measured by looking at frequency of use in past 30 days with the Alcohol Use Disorders Identification Test (AUDIT), reported about marijuana use at the 3 month follow-up. The mean of each the assessment only and intervention group was used. Scores ranged from 0 to 13 for the follow-up sample. Higher scores mean more frequent use of the substance.
Child Abuse Potential
Time frame: baseline and 3 month follow-up
Change score was calculated by taking the follow-up scores on the Brief Child Abuse Potential Inventory (BCAP) and subtracting the baseline score. The possible total score for the BCAP ranges from 0 to 24. Therefore, the possible range of scores for the change calculation (reported below) is -24 to +24. Higher scores indicate higher risk at the follow-up visit (worse outcome).
Treatment Engagement
Time frame: at 3 month follow-up
The number of participants who reported seeking outpatient substance abuse treatment since baseline (either at a treatment facility or through outpatient counseling).

1 secondary outcome

Depression
Time frame: at 3 month follow-up

Results and safety

Results posted to the registry on 8 Aug 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Assessment Only	50	50
Brief Intervention Session	50	50

Primary outcome: Alcohol Use

Time frame: 3 month follow-up. Mean (Standard Deviation). Unit: units on a scale

Measure	Assessment Only n = 19	Brief Intervention Session n = 24
Value	1.37 (1.57)	0.92 (1.35)

Population analysed: A total of 43 participants returned for follow-up and were the only participants analyzed on this outcome.

Primary outcome: Drug Use

Time frame: 3 month follow-up. Mean (Standard Deviation). Unit: units on a scale

Measure	Assessment Only n = 19	Brief Intervention Session n = 24
Value	1.89 (3.6)	0.63 (1.76)

Population analysed: A total of 43 participants returned for follow-up and were the only participants analyzed on this outcome.

Primary outcome: Child Abuse Potential

Time frame: baseline and 3 month follow-up. Mean (Standard Deviation). Unit: units on a scale

Measure	Assessment Only n = 19	Brief Intervention Session n = 24
Value	-1.8 (5.8)	-2.4 (5.7)

Primary outcome: Treatment Engagement

Time frame: at 3 month follow-up. Number. Unit: participants

Measure	Assessment Only n = 19	Brief Intervention Session n = 24
Value	0	1

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Assessment Only	0 of 50 (0%)	0 of 50 (0%)	Not reported
Brief Intervention Session	0 of 50 (0%)	0 of 50 (0%)	Not reported

Limitations and caveats (from the sponsor): This study is limited by the relatively small sample size and the restriction to low-income, urban women, thus limiting generalizability to other populations.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 11876674Delaney-Black V, Covington C, Ondersma SJ, Nordstrom-Klee B, Templin T, Ager J, Janisse J, Sokol RJ. Violence exposure, trauma, and IQ and/or reading deficits among urban children. Arch Pediatr Adolesc Med. 2002 Mar;156(3):280-5. doi: 10.1001/archpedi.156.3.280.
Background: PubMed 15901230Ondersma SJ, Chaffin MJ, Mullins SM, LeBreton JM. A brief form of the child abuse potential inventory: development and validation. J Clin Child Adolesc Psychol. 2005 Jun;34(2):301-11. doi: 10.1207/s15374424jccp3402_9.
Background: PubMed 15611328Mullins SM, Bard DE, Ondersma SJ. Comprehensive services for mothers of drug-exposed infants: relations between program participation and subsequent child protective services reports. Child Maltreat. 2005 Feb;10(1):72-81. doi: 10.1177/1077559504272101.
Background: PubMed 15223094Mullins SM, Suarez M, Ondersma SJ, Page MC. The impact of motivational interviewing on substance abuse treatment retention: a randomized control trial of women involved with child welfare. J Subst Abuse Treat. 2004 Jul;27(1):51-8. doi: 10.1016/j.jsat.2004.03.010.

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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 1/2 study testing Brief motivational intervention in people with Substance Use, 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 1 inclusion and 1 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 Aug 2013. 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.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Yes. Results are posted in the registry (first posted 8 Aug 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Alcohol Use (time frame: 3 month follow-up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00230009, which also lists 4 linked publications.

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 Aug 2013.