# Presentation: 309944

## Motivational Behavioral Interventions to Reduce the Riskof Alcohol-Exposed Pregnancies Results from a Feasibility Study and Discussion of an Ongoing Randomized Clinical TrialMary Marden Velasquez, Ph.D.Department of Family Practice and Community MedicineThe University of Texas Health Science Center at HoustonSchool of Medicine

##           PROJECT CHOICES 

**          ****PROJECT CHOICES **

**A PRECONCEPTIONAL APPROACH **

## EPIDEMIOLOGIC SURVEY

**(****Project CHOICES Research Group, AJPM, 2002; 23 (3)**
*Writing Team, Mary Nettleman (chair), Joseph Carbonai, R.Louise Floyd, *
*Patricia Dolan Mullen, Jasjeet Sidhu*
*Analytic Team, J. Carbonari (chair), K. vonSternberg, J. Baio, J. Sidhu*

## Centers for Disease Control and Prevention
R. Louise Floyd, DSN

University of Texas Health Science Center
Mary Marden Velasquez, PhD
Patricia Dolan Mullen, DrPH

Virginia Commonwealth University
Mary Nettleman, MD
Karen Ingersoll, PhD

NOVA Southeastern-Florida
Mark Sobell, PhD
Linda Sobell, PhD

- R. Louise Floyd, DSN
*University of Texas Health Science Center*
- Mary Marden Velasquez, PhD
- Patricia Dolan Mullen, DrPH
*Virginia Commonwealth University*
- Mary Nettleman, MD
- Karen Ingersoll, PhD
*NOVA Southeastern-Florida*
- Mark Sobell, PhD
- Linda Sobell, PhD

## EPIDEMIOLOGIC SURVEY

- Characterize the population including level of risk for AEP
- Identify variables correlated with risk
- Identify independent predictors of risk

## SETTINGS

**Jail**
**Treatment Center**
- 	**University of Texas Health Science Center**
**	****Inner City Primary Care**
**Inner City GYN**
- 	Virginia Commonwealth University
**Primary Care Clinics in an HMO**
**Media Recruits**
- 	NOVA Southeastern-Florida

## OVERVIEW

**Women, aged 18-44 years**
**Survey designed by Study Team**
**Administered by trained interviewer on site with each survey taking about 30 minutes**
**Over 18 months**

## DEFINITION OF “AT RISK”

_**LAST 90 DAYS**_
**FERTILE **
**UNPROTECTED SEX**
**8 OR MORE DRINKS PER WEEK **_**OR**_
_**>**_** 5 DRINKS IN ONE DAY MORE THAN ONCE IN LAST 6 MONTHS**

## 2672 RESPONDENTS

- 62%     African American
- 21%     White
-    8%     Hispanic
-   6%      Native American
-    3%     Other

## Community-based Settings with High Proportion Of  Women at-Risk  for an Alcohol Exposed Pregnancy

**Notes:**
Risk for alcohol-exposed pregnancy was defined by:
Fertile and had unprotected intercourse in past 6 months
Risk-level alcohol consumption (average 8 or more drinks per week or binged twice or more n past 6 months)
Risk was higher in settings where women were expected to engage in higher risk-taking behavior
All settings showed higher proportion of risk than we estimated from national population estimates
Jail & recovery sites categorized as higher risk, health clinic and media samples categorized as lower risk

## DEMOGRAPHICS

- 17 % were legally married
- 51% were employed
- 68% were high school grads or equivalent

## DEMOGRAPHICS: AGE

## INCOME

## FERTILITY

- 32% infertile, 9% abstain
- 13% pregnant or trying
- 25% contracepting correctly
- 12% not contracepting correctly
- 8% not using contraception

## ALCOHOL USE

- 71% of respondents drank
- 31% were binge drinkers
- (5 or more drinks on a day)
- 25% were frequent drinkers
- (8 or more drinks per week)

## AT RISK FOR AEP

- 333 Respondents (12.5%)
- National estimates for the general population suggest a 1% to 2% risk
- Respondents were 6.9 times more likely to be at risk for AEP (95% CL 5.2-9.3, p=0.0001) than general population
- All sites were at increased risk (p<0.05)

## % AT RISK FOR AEP

## Comparison group was women who were not at risk but who were sexually active and fertile
Univariate and Multivariate Analysis

- Univariate and Multivariate Analysis

- AT-RISK WOMEN: FACTORS ASSOCIATED WITH RISK

## At-Risk Women vs Not At Risk

|  | Odds Ratio | C.I. |
| --- | --- | --- |
| Ever used drugs | 8.3 | 5.1-13.6 |
| Current drug use | 7.2 | 5.3-9.8 |
| Hx of Tx for Et/drugs | 5.1 | 3.9-6.6 |
| Ever smoked | 5.1 | 3.5-7.6 |
| Ever homeless | 3.9 | 3.0-5.1 |
| Hx of Mental Tx | 3.1 | 2.3-4.3 |

- Univariate

## Other significant univariate correlates (p<0.001) included:

- At-Risk Women vs Not At Risk

**Age > 30****	**
**White race**
**Less Education**
**Started Drinking         <age 16**
**Hx of Inpt Tx for Drug/Et/Mental**

**Hx of Physical Abuse**
**Unemployed**
**Current Smoker**
**No Health Ins**
**Perceived Poor Health**

## MULTIVARIATE ANALYSIS CURRENT BEHAVIORS (p<0.0001)

|  | Odds Ratio |  C.I. |
| --- | --- | --- |
| Current Drug Use | 5.1 | 3.6-7.1 |
| Current Smoker | 2.3 | 1.7-3.1 |

## MULTIVARIATE ANALYSISHISTORICAL VARIABLES (p<0.0001)

- MULTIVARIATE ANALYSISHISTORICAL VARIABLES (p<0.0001)

|  | Odds Ratio |     C.I. |
| --- | --- | --- |
| Ever Used Drugs | 3.1 | 1.8-5.4 |
| Inpt Tx for Drug/Et | 2.3 | 1.8-3.1 |
| Physical Abuse | 1.9 | 1.4-2.5 |
| Ever smoke 100 cigs | 1.9 | 1.3-2.7 |
| Inpt Tx for Mental Health | 1.6 | 1.1-2.3 |

## SUMMARY

**12.5% of women were at risk for an alcohol-exposed pregnancy**
**Risk for AEP was associated with a history of multiple problems, many of which persisted into the present**

## CONCLUSIONS TO DATE

**ALL Project CHOICES SETTINGS HAVE HIGHER PROPORTIONS OF WOMEN AT RISK FOR AN AEP THAN THE ESTIMATED RATE FOR WOMEN AGED 18-45 YRS. OVERALL (<2%)**
**SETTINGS  REPRESENT IDEAL LOCALES FOR DESIGNING AND TESTING INTERVENTIONS TO REDUCE THE RATE OF AEP**

## Project CHOICES Feasibility StudyReducing the Risk of Alcohol-Exposed Pregnancies:  A Study of a Motivational Intervention in Community Settings

*Project CHOICES Intervention Research Group, Pediatrics, 2003;111*
*Writing Team, M. Velasquez (chair), K. Ingersoll, L. Floyd, M. Sobell*
*Analytic Team, J. Carbonari (chair), K. vonSternberg, J. Baio, J. Sidhu*

## Slide 26

## Objective: Prevent Alcohol-Exposed Pregnancies

-  **Reduce Drinking**
**or**
** ****Contracept Effectively**
**or**
** ****Both**

## Definition of “Not at Risk”

- Drinks ≤ 7 drinks/week & no days ≥ 5 drinks
- or
- Contracepts Effectively
- or
- Both

## Recruitment

- 2,384 women screened
- 230 eligible
- 190 consented and enrolled

## Project CHOICES Intervention

**Counseling Session 1**

**Counseling Session 2**

**Gyn/ family**
** ****planning **
**visit**

**Counseling Session 3**

**Counseling Session 4**

**3 month follow up**

**6 month follow up**

**Notes:**
Now I’ll review the flow of the Project CHOICES intervention.

## What Happened?

## Completion Rates

**Counseling Session 1****	****100.0%**
**Counseling Session 2****	****92.0%**
**Counseling Session 3****	****67.2%**
**Counseling Session 4****	****58.7%**
**Ob/Gyn Session****	****62.2%**
**3-Month Follow-Up****	****74.6%**
**6-Month Follow-Up****	****75.3%**

## Pre-Intervention100% At Risk

**6 Months Post-Intervention**
** ****68.2% Not At Risk**
** ****31.8% At Risk**

## Routes to “Not At Risk”

**18.4% Reduced Drinking**
**34.0% Contracepted****	****	****	****	**** Effectively**
**47.6% Did Both**

## Completion And Success

**Mean (SD) No. Sessions Completed**
** ****Not At Risk****	****4.33 (1.17)**
** ****Still At Risk****	****3.96 (1.37)**
**	****	****n.s.**

## “Not At Risk” X Setting

**	****Setting****	****% Not At Risk**
**Jail****	****	****66.7%**
**Treatment Center****	****57.1%**
**Inner City Primary Care****	****57.1%**
**Inner City Gyn****	****66.7%**
**Media Recruits****	****79.5%**
**Broward Co. Prim. Care****	****60.0%**

## Predictors of “Not At Risk”

**Mean (SD) AUDIT Score**
**	****Not At Risk****	****14.97 (9.95)**
**	****Still At Risk****	****19.60 (19.98)**
***P***** = .009**

## Predictors of “Not At Risk”

**Binged in Past 30 Days at Baseline**
- 	 **Not At Risk****	****80.0%**
**	**** ****Still At Risk****	****93.6%**
***P***** = .034**

## Non-Predictors of Outcome

-  **Age**
** ****Marital Status**
** ****Income**
** ****Ethnicity**
** ****Sites & Settings**
** ****Sexually Active at 6-Month Follow-Up**
** ****At Baseline: Mean Drinks/Week; Most Drinks Past 30 Days; Binged in Past 6 Months**

## Conclusions

**Findings suggest the intervention is promising**
**More women chose to contracept than to reduce drinking**
**Problem severity may predict outcome**
**Shows enough promise to move on to a randomized control trial (Efficacy Study)**

## Project CHOICES Efficacy Study A CDC funded multi-site collaborative RCT to evaluate the efficacy of a motivational intervention for reducing alcohol-exposed pregnancies in high-risk women. Women are recruited from six special community-based settings found to have high concentrations of women at high-risk of having an alcohol-exposed pregnancy. 

## Project CHOICES Demographics

- Mean age of 31.4 years (SD=7.59).
-  49.1% Black, 38.5% White, and 12.4% Hispanic

## TimeLine Follow-Back

| Sunday | Monday | Tuesday | Wednesday | Thursday | Friday |  | Saturday |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 1 | 2 | 3 | 4 | 5 | 6 |  | 7 |
| A:
VI:     Y   N
BC:    Y   N
T: | A:
VI:     Y   N
BC:    Y   N
T: | A:
VI:     Y   N
BC:    Y   N
T: | A:
VI:     Y   N
BC:    Y   N
T: | A:
VI:     Y   N
BC:    Y   N
T: | A:
VI:     Y   N
BC:    Y   N
T: |  | A:
VI:     Y   N
BC:    Y   N
T: |
| 8 | 9 | 10 | 11 | 12 | 13 |  | 14 |
| A:
VI:     Y   N
BC:    Y   N
T: | A:
VI:     Y   N
BC:    Y   N
T: | A:
VI:     Y   N
BC:    Y   N
T: | A:
VI:     Y   N
BC:    Y   N
T: | A:
VI:     Y   N
BC:    Y   N
T: | A:
VI:     Y   N
BC:    Y   N
T: |  | A:
VI:     Y   N
BC:    Y   N
T: |
| CODES: |  |  |  |  |  |  |  |
| 	A:     Alcohol Use
	VI:   Vaginal Intercourse
	BC:  Birth Control
	T:     Type of birth control |  |  |  | C:  Condom
P:   Birth Control Pill
D:  Diaphragm
I:    IUD |  | S:   Spermicide
N:  Norplant
E:  Depo-Provera
Other:  (write in) |  |