Trial Outcomes & Findings for Brief Intervention in At-Risk First-time Mothers (NCT NCT00230009)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

100 participants

Primary outcome timeframe

3 month follow-up

Results posted on

2013-08-08

Participant Flow

Participants for this phase were recruited from a large prenatal care clinic affiliated with Wayne State University. Participants were either (a) approached while in the waiting area, or (b) identified via a participant database as being willing to be contacted regarding research studies.

Participant milestones

Participant milestones
Measure	Assessment Only Brief assessment using Audio Computer Assisted Self Interview (A-CASI) technology to obtain the data only.	Brief Intervention Session Brief assessment using Audio Computer Assisted Self Interview (A-CASI) technology to obtain the data. Plus brief therapist-delivered motivational intervention, which was tied to the results of the A-CASI assessment (results from which were viewable immediately by the therapist).
Single Session Intervention/Control STARTED	50	50
Single Session Intervention/Control COMPLETED	50	50
Single Session Intervention/Control NOT COMPLETED	0	0
Follow-up STARTED	50	50
Follow-up COMPLETED	19	24
Follow-up NOT COMPLETED	31	26

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Brief Intervention in At-Risk First-time Mothers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Assessment Only n=50 Participants	Brief Intervention Session n=50 Participants	Total n=100 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	50 Participants n=5 Participants	50 Participants n=7 Participants	100 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	22.6 years STANDARD_DEVIATION 4.4 • n=5 Participants	23.6 years STANDARD_DEVIATION 4.5 • n=7 Participants	23.1 years STANDARD_DEVIATION 4.4 • n=5 Participants
Sex: Female, Male Female	50 Participants n=5 Participants	50 Participants n=7 Participants	100 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	50 participants n=5 Participants	50 participants n=7 Participants	100 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 month follow-up

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

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.

Outcome measures

Outcome measures
Measure	Assessment Only n=19 Participants	Brief Intervention Session n=24 Participants
Alcohol Use	1.37 units on a scale Standard Deviation 1.57	0.92 units on a scale Standard Deviation 1.35

PRIMARY outcome

Timeframe: 3 month follow-up

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

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.

Outcome measures

Outcome measures
Measure	Assessment Only n=19 Participants	Brief Intervention Session n=24 Participants
Drug Use	1.89 units on a scale Standard Deviation 3.6	0.63 units on a scale Standard Deviation 1.76

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Assessment Only n=19 Participants	Brief Intervention Session n=24 Participants
Child Abuse Potential	-1.8 units on a scale Standard Deviation 5.8	-2.4 units on a scale Standard Deviation 5.7

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Assessment Only n=19 Participants	Brief Intervention Session n=24 Participants
Treatment Engagement	0 participants	1 participants

SECONDARY outcome

Timeframe: at 3 month follow-up

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.

Outcome measures

Outcome measures
Measure	Assessment Only n=19 Participants	Brief Intervention Session n=24 Participants
Depression	19.74 units on a scale Standard Deviation 6.2	20.33 units on a scale Standard Deviation 6.5

Adverse Events

Assessment Only

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Brief Intervention Session

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Steven J. Ondersma, ,PI

Wayne State University

Phone: 313-577-6680

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place