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| ID | Type | Description | Link |
|---|---|---|---|
| K23DA000516 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Assessment only | No Intervention | ||
| Brief intervention session | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brief motivational intervention | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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). | 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). | at 3 month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at 3 month follow-up |
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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
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| Name | Affiliation | Role |
|---|---|---|
| Steven J Ondersma, Ph.D. | Wayne State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wayne State University | Detroit | Michigan | 48207 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11876674 | Background | 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. | |
| 15901230 | Background | 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. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Assessment Only | Brief assessment using Audio Computer Assisted Self Interview (A-CASI) technology to obtain the data only. |
| FG001 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Single Session Intervention/Control |
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| Follow-up |
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| ID | Title | Description |
|---|---|---|
| BG000 | Assessment Only | |
| BG001 | Brief Intervention Session | |
| BG002 | Total |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | A total of 43 participants returned for follow-up and were the only participants analyzed on this outcome. | Posted | Mean | Standard Deviation | units on a scale | 3 month follow-up |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Assessment Only |
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This study is limited by the relatively small sample size and the restriction to low-income, urban women, thus limiting generalizability to other populations.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steven J. Ondersma, ,PI | Wayne State University | 313-577-6680 | s.ondersma@wayne.edu |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| 15611328 | Background | 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. |
| 15223094 | Background | 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. |
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|
Total of all reporting groups
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
|
|
| 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. | A total of 43 participants returned for follow-up and were the only participants analyzed on this outcome. | Posted | Mean | Standard Deviation | units on a scale | 3 month follow-up |
|
|
|
| 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). | Posted | Mean | Standard Deviation | units on a scale | baseline and 3 month follow-up |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | at 3 month follow-up |
|
|
|
| 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). | Posted | Number | participants | at 3 month follow-up |
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | Brief Intervention Session | 0 | 50 | 0 | 50 |
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