Substance Use
Conditions
Keywords
child abuse, child neglect, substance use, violence exposure, brief intervention
Brief 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.
Interventions
BEHAVIORALBrief motivational intervention
Sponsors
National Institute on Drug Abuse (NIDA)
Wayne State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
Pregnant, expecting first child Inclusion Criteria: Receipt of public assistance (e.g., Medicaid, Food Stamps), ability to communicate in English
Exclusion criteria
Frank psychosis or other cognitive impairment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Alcohol Use | 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 | 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 | 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 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depression | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Assessment Only | 50 |
| Brief Intervention Session | 50 |
| Total | 100 |
Baseline characteristics
| Characteristic | Brief Intervention Session | Assessment Only | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 50 Participants | 50 Participants | 100 Participants |
| Age Continuous | 23.6 years STANDARD_DEVIATION 4.5 | 22.6 years STANDARD_DEVIATION 4.4 | 23.1 years STANDARD_DEVIATION 4.4 |
| Region of Enrollment United States | 50 participants | 50 participants | 100 participants |
| Sex: Female, Male Female | 50 Participants | 50 Participants | 100 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 50 | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
Primary
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.
Time frame: 3 month follow-up
Population: A total of 43 participants returned for follow-up and were the only participants analyzed on this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Assessment Only | Alcohol Use | 1.37 units on a scale | Standard Deviation 1.57 |
| Brief Intervention Session | Alcohol Use | 0.92 units on a scale | Standard Deviation 1.35 |
Primary
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).
Time frame: baseline and 3 month follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Assessment Only | Child Abuse Potential | -1.8 units on a scale | Standard Deviation 5.8 |
| Brief Intervention Session | Child Abuse Potential | -2.4 units on a scale | Standard Deviation 5.7 |
Primary
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.
Time frame: 3 month follow-up
Population: A total of 43 participants returned for follow-up and were the only participants analyzed on this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Assessment Only | Drug Use | 1.89 units on a scale | Standard Deviation 3.6 |
| Brief Intervention Session | Drug Use | 0.63 units on a scale | Standard Deviation 1.76 |
Primary
Treatment Engagement
The number of participants who reported seeking outpatient substance abuse treatment since baseline (either at a treatment facility or through outpatient counseling).
Time frame: at 3 month follow-up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Assessment Only | Treatment Engagement | 0 participants |
| Brief Intervention Session | Treatment Engagement | 1 participants |
Secondary
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.
Time frame: at 3 month follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Assessment Only | Depression | 19.74 units on a scale | Standard Deviation 6.2 |
| Brief Intervention Session | Depression | 20.33 units on a scale | Standard Deviation 6.5 |