# Presentation: 656631

## 		                     Project Success

**	****	****                     ****Project Success**
-               testing the efficacy of a dual focus
-                transtheoretical model-based
-  motivational enhancement intervention **+**
- jail-to-community transition assistance
- to prevent alcohol-exposed pregnancy
- after a jail term

- National Institute on Drug Abuse Conference: Children of Parents in the Criminal Justice System:  Children at Risk.  Bethesda, Nov. 6, 2006

## Acknowledgements

- Mary Marden Velasquez, Co-PI
- Joseph P. Carbonari, Co-I, Statistician
- Kirk von Sternberg, Co-I, Data Manager
- Gaye Cummins, Project Director
- Charles Green, Data Analyst
**University of Texas Health Science Center at Houston**** **
- Harris County, Plane State, Brazoria County,
- Ft. Bend County, and Montgomery County jails

**Funded by NIAAA** (RO1 AA 12514-03S1)

## Background

- Half of U.S. pregnancies are unplanned (49%);  women with an unplanned pregnancy report more binge drinking *(Naimi**et al** 03)*
- Women who stop drinking when they notice they are pregnant may still have exposure of _>_6 wks or more *(Floyd**et al** 99)*; 50% of pregnant woman reported drinking in the 3 mos before recognizing the pregnancy *(Floyd & Sidhu, 04)*
*“*Preconception planning”  was introduced by the Expert Panel on the Content of Prenatal Care *(89)* and adopted by FAS-prevention scientists at CDC 9 yrs ago when they initiated Project                a cooperative research project focused on non-pregnant women *at risk* of an alcohol-exposed pregnancy (AEP)

- CHOICES

## Project  

**Epidemiology study** in 6 settings:  highest prevalence of AEP—20% among jail inmates (and alcohol and drug treatment center residents) in Houston
- 5x higher than low income primary care clinics (Virginia & Florida); 11x higher than U.S. females aged 18-44
**Feasibility study** in the jail:  100% consent among at risk inmates
- High participation for in jail sessions; lower for free world (with incentives) – see table
- 6 months after release, 33% reported less  drinking + increased birth control; 13% reduced drinking only; 23% increased birth control only

| Treatment
Time before/after
release from jail | 
$ | 
%  |
| --- | --- | --- |
| Session 1
2 wks before  | $10 | 100 |
| Session 2 
1 wk before | $10 | 100 |
| Session 3
<3 wks after | $20 |   41 |
| Session 4
<6 wks after | $30 |   35 |
| Planned
Parenthood 
1-4 wks after | 
$20 |   
41 |

- CHOICES

## Objective 

- To reduce the risk of an alcohol-exposed pregnancy—AEP—after a jail term among previously at risk jail inmates
- The criterion variable is ....

## Risk of Alcohol Exposed Pregnancy

| 
At Risk | 
Not at Risk |
| --- | --- |
| 
Not at Risk | 
Not at Risk |

- Yes

- Yes

- No

- No

**Risk Drinking**

**Unsafe Sex**

- Yes =** **≥1 occurrence of vaginal sex without effective birth control

- Yes = ≥1 occurrence of _>_ 5 drinks in a day or _>_7 drinks in a week

## TimeLine Follow-Back

| Sunday | Monday | Tuesday | Wednesday | Thursday | Friday | Saturday |
| --- | --- | --- | --- | --- | --- | --- |
| 1 | 2 | 3 | 4 | 5 | 6 | 7 |
| ETOH_____ M#___BC__ O#___BC__
 | ETOH_____ M#___BC__ O#___BC__
 | ETOH_____ M#___BC__ O#___BC__
 | ETOH_____ M#___BC__ O#___BC__
 | ETOH_____ M#___BC__ O#___BC__
 | ETOH_____ M#___BC__ O#___BC__
 | ETOH_____ M#___BC__ O#___BC__
 |
| 8 | 9 | 10 | 11 | 12 | 13 | 14 |
| ETOH_____ M#___BC__ O#___BC__
 | ETOH_____ M#___BC__ O#___BC__
 | ETOH_____ M#___BC__ O#___BC__
 | ETOH_____ M#___BC__ O#___BC__
 | ETOH_____ M#___BC__ O#___BC__
 | ETOH_____ M#___BC__ O#___BC__
 | ETOH_____ M#___BC__ O#___BC__
 |
| If not in the community, circle the date and code as follows:   I: Incarcerated,  H: Hospital,  R: Residential Tx, or  DT: Detox; Drinking  (ETOH)  Write beverage, quantity
(Vaginal) sex - M: Main Partner  O: Other partners  BC: Birth Control – Fill in as follows:   
C: Condoms   P: Pills   D: Diaphragm  I:  IUD   S: Spermicide  N: Norplant  DP: Depo-Provera     0: None  EC: Emergency contraception   Other:  (write in method) |  |  |  |  |  |  |

## Method

- Study Design:  RCT with all consenting, eligible women from 5 Houston area jails
- Follow-up:  Personal interviews 3- and 6-months after release from jail
- Data collectors blinded to study assignment
- Cash reimbursement for time and expenses:
-  free world intervention sessions ($30 each)
-  follow-up interviews ($35 and $50)

## Project SUCCESS Intervention

**Counseling**
**Session #1: **10-14 days before release

**Community **
**Resources**
**Session:**  2-10 days
- before  release

**Counseling **
**Session #3:  **2 wks
- after release

**Counseling **
**Session #4:  **4 wks
- after release

**Counseling**
**Session #2:  **2-7
- days before release

**Birth Control **
**Education & **
**Services Session:**
- _<2_ wks after release

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

## Motivational Interviewing Principles 

- Motivational Enhancement
- Counseling Sessions

**Express empathy**
**Develop discrepancy**
**Avoid argumentation**
**Roll with resistance**
**Support self-efficacy**

##  Counseling Sessions
Session 1:

Introduced ME approach and rationale
Administered Readiness, Importance and Confidence rulers for alcohol, birth control to elicit “change talk”
Discussed release - encouraged thinking about any changes she might want to make in her life, including alcohol and birth control practices 
Discussed alcohol use prior to jail; explored how drinking affected her work, family, social relationships, etc.

- Session 1:
- Introduced ME approach and rationale
- Administered Readiness, Importance and Confidence rulers for alcohol, birth control to elicit “change talk”
- Discussed release - encouraged thinking about any changes she might want to make in her life, including alcohol and birth control practices
- Discussed alcohol use prior to jail; explored how drinking affected her work, family, social relationships, etc.

## Session 1...

Explored her thoughts and feelings about future pregnancies using Seriousness and Susceptibility rulers
Discussed the idea of a “promise to self “ to postpone pregnancy for ≥ 6 months or until she is in a position to make a longer-term decision about a baby 

- Explored her thoughts and feelings about future pregnancies using Seriousness and Susceptibility rulers
- Discussed the idea of a “promise to self “ to postpone pregnancy for ≥ 6 months or until she is in a position to make a longer-term decision about a baby

## 

Session 2:

Presented  “Daily Journal” and taught to self-monitoring of drinking, sex, and birth control use 
Presented and discussed her personalized feedback report -alcohol use, pregnancy risk, health risks before coming to jail
Discussed contraceptive methods currently available and provided printed materials on each method
Discussed the family planning visit and problem-solved any barriers to attendance
Reviewed scaling rulers completed in Session 1

- Session 2:
- Presented  “Daily Journal” and taught to self-monitoring of drinking, sex, and birth control use
- Presented and discussed her personalized feedback report -alcohol use, pregnancy risk, health risks before coming to jail
- Discussed contraceptive methods currently available and provided printed materials on each method
- Discussed the family planning visit and problem-solved any barriers to attendance
- Reviewed scaling rulers completed in Session 1

## Jail-to-Community Transition Assistance

- “One Woman’s Release Story”
- Counseling session #2 emphasized planning for release, taxi voucher
- Release folder:  taxi voucher, copies of materials, reminder cards for free world sessions
-  +
- (all study participants)
-      bus tokens, coins for ‘phone, condoms, information on domestic violence and emergency contraception, condoms, appt cards for follow-up interviews, the study toll free number, and donated personal items

## Written with inmates
Describes temptations, ease of slipping into the “old life”
Emphasizes the importance of making a plan 

- Written with inmates
- Describes temptations, ease of slipping into the “old life”
- Emphasizes the importance of making a plan

## Pre-release Community Resources Group Session with an MSW

- Recommendations individualized - based on requests and needs, e.g.
*ID  *
*GED*
*job training *
*housing *
*CHIPS, “Goldcard”*
*Dental*
*Clothing*

- Multiple basic needs referred to “case management”

- Velasquez, Maurer, Crouch, DiClemente, 2001 “Group Treatment for Substance Abuse: a Stages of Change Manual”

**Notes:**
The MSW was intimately familiar with Harris County resources.  She works with homeless and other populations with multi-needs.
Velasquez, Maurer, Crouch, DiClemente, 2001 “Group Treatment for Substance Abuse: a Stages of Change Manual” ISBN 1-57230-625-4

## Release Folder 

- Release Folder

## Session 3:

- Session 3:
** **
**  **Elicited woman’s feelings about her progress now that she
-      has been released
-   Checked in family planning visit  (Did she attend?  What  was
-      the outcome of the visit?  Birth control choice?  If she did not
-      attend, what are the barriers?  Explored possible ways to
-      overcome any barriers)

## Session 3...

Reviewed Daily Journal for both behaviors.  Discussed attempts to change and any barriers encountered since the last session. Explored and debriefed risky situations (i.e., did she have unprotected sex?  Had she been drinking heavily?)
Focused primarily on the target behavior that was not discussed as thoroughly in Session 2.   (Here, in particular, used ME skills to increase motivation as appropriate)
Revisited and revised scaling rulers, goal statements and change plans based on the woman's experiences since the in-jail sessions

- Reviewed Daily Journal for both behaviors.  Discussed attempts to change and any barriers encountered since the last session. Explored and debriefed risky situations (i.e., did she have unprotected sex?  Had she been drinking heavily?)
- Focused primarily on the target behavior that was not discussed as thoroughly in Session 2.   (Here, in particular, used ME skills to increase motivation as appropriate)
- Revisited and revised scaling rulers, goal statements and change plans based on the woman's experiences since the in-jail sessions

## Birth Control Education 

- Appointment _________________

-                         Planned Parenthood
-                                           3601 Fannin
-                             Gloria
-                                        713-831-6564

- Birth Control Education
- & Services Session

- Individualized birth control education
- Well-woman exam (Pap smear, clinical breast exam)
- STD testing
- HIV testing
- Birth control services for 6 months

## Session 4:
Reviewed and summarized the previous sessions
Reviewed goals and change plans
Problem solved, reinforced goals, revisited temptation and confidence graphs, worked toward strengthening commitment to change
Discussed plans for the future

- Reviewed and summarized the previous sessions
- Reviewed goals and change plans
- Problem solved, reinforced goals, revisited temptation and confidence graphs, worked toward strengthening commitment to change
- Discussed plans for the future

## Inclusion Criteria 

- Intervention-related:
- Release to the community in _>_2 weeks, _<_6 weeks
- Staying around Houston (intervention period)
- Not in protective custody or the jail mental health unit
- Risk-related
- Age <44 years (>18)
- Fertile
- _<_3 months before jail
- vaginal sex without birth control
- drank alcohol _>_5 drinks per day or _>_7 drinks per week
- Not pregnant or planning a pregnancy <6 months after release
- Research-related
- Staying around Houston (follow-up period)
- Could provide _>_2 locators

- No risk last 3 mos in free world:

**No alcohol**
**n=1217**

- Protected now:
- Depo n=127
- IUD, Norplant n=69

- Enrollment (Eligibility and Recruitment)

- Post-re-lease plan:
- Holds, etc. n=329

- No English n=188

- Pregnancy:
**Pregnant  now n=137**

- Infertile:
- Doctor told her she isn’t fertile   n=246
- Hysterectomy n=239
- Menopause n=158
- No ovaries n=94

- Group screening n=3276

- Not interested n=270

- Assessed for eligibility after prescreening for release date, age 18-44 n=3546

- Eligible for individual screening n=441

- Tubal
- ligation
- n=984

**Moving**
**n=697**

**No sex n=548**

**Planning a**
** ****baby  ****≤6 **
** ****mos, n=398**

## Follow-up

- Control group n=83

- Intervention group n=133

- 3-mo. follow-up:
- Completed core interview n=59
- Missed interview n=24

- 3-mo. follow-up:
- Completed core interview n=87
- Missed interview n=45
- Located, not available for inter-
-  view per jail n=1

- 6-mo. follow-up:
- Completed core interview n=48
- Missed interview n=33
- <2 periods of  ≥ 30 continuous free world days n=2

- 6-mo. follow-up:
- Completed Core interview n=69
- Missed interview n=57
- <2 periods of  ≥ 30 continuous
-   free world days n=7

**TLFB data for 2 periods of ≥ 30 continuous free world days n= 148**:
-  **Control group: n = 74%**
**Intervention group: n = 70%**

## Participant Socio-demographic Profile (n=216)

- Average age 31 years (SD=7)
- 47% <12th grade, no GED
- 42% Black, 12% Hispanic, 47% White
- 51% married, living with a partner
- 43% <$20,000 annual income

## Participant Risk Profile 

- Lifetime
- Physically abused = 60%
- Median number of months incarcerated = 9 mo.
- Inpatient drug treatment = 50%
- Inpatient mental health treatment = 15%
- Year before jail
- Homeless _>_2 days = 34%
- Met drug dependence criteria = 80%
- Treated for a sexually transmitted infection = 26%

## Intervention Exposure

|  |  |
| --- | --- |
| Jail                |  |
| Session 1   | 99 %  |
| Session 2  | 92 %  |
| Release Folder  | 94 %  |
| Taxi Voucher  | 36 %  |
| Community Resources Session  | 79 %  |
| Free world  |  |
| Session 3  | 39 %  |
| Birth Control Education 
& Services Session | 40 %  |
| Session 4  | 31 %  |

## Proportions in 4 Outcome Categories 

- Proportions in 4 Outcome Categories
- by Condition and Time from Release

## Logistic Regression - Generalized Estimating Equation Approach

**Logistic Regression - Generalized Estimating Equation Approach**

- 1

- 2

- 4

- 3

- 5

- 6

## 2

- 1

- 3

- 5

- 4

- 6

## 2

- 5

- 4

- 6

- 3

- 1

## Risk Drinking<4 drinks in a day and <7 drinks in any one week

| Wald Statistics For Type 3 GEE Analysis |  |  |  |
| --- | --- | --- | --- |
| Source | DF | Chi-Square | Pr > ChiSq |
| CONDITION | 1 | 7.31 | 0.0069 |
| TIME | 5 | 9.99 | 0.0754 |
| CONDITION*TIME | 5 | 2.08 | 0.8386 |

| Contrast Estimate Results |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Label | Estimate | Standard Error | α | Confidence Limits |  | Chi
Square | Pr > ChiSq |
| Condition | 0.8381 | 0.3100 | 0.05 | 0.2306 | 1.4457 | 7.31 | 0.0069 |
| Exp(Con-dition) | 2.3121 | 0.7167 | 0.05 | 1.2594 | 4.2447 |  |  |

## Some Conclusions

- There is need for intervention programs–
- drugs *and* alcohol
- STI/HIV prevention *and* contraception
- 10% planning to get pregnant
- Jail release conditions may almost assure failure
- Women receptive to release planning; ME style welcome
- Overconfidence important challenge for treatment under restrained conditions; groups are natural next step
- Need to reach more women–upcoming release too restrictive in the chaos of jail
- Mandated tx programs-better conditions for intervention/eval-  uation; but, some groups, eg, Af American women excluded

## Risk of Alcohol-Exposed Pregnancy

| Wald Statistics For Type 3 GEE Analysis |  |  |  |
| --- | --- | --- | --- |
| Source | DF | Chi-Square |  Pr > ChiSq |
| CONDITION | 1 | 2.56 | 0.1099 |
| TIME | 5 | 5.01 | 0.4143 |
| CONDITION*TIME | 5 | 5.09 | 0.4045 |

| Contrast Estimate Results |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Label | Estimate | Std Error |    α | Confidence
Limits |  | Chi Square | Pr > ChiSq |
| Condition | 0.4957 | 0.3101 | 0.05 | -0.1121 | 1.1036 | 2.56 | 0.1099 |
| Exp
(Condition) | 1.6417 | 0.5091 | 0.05 | 0.8940 | 3.0149 |  |  |

## Unsafe Sex >1 occurrences of vaginal sex without birth control

| Wald Statistics For Type 3 GEE Analysis |  |  |  |
| --- | --- | --- | --- |
| Source | DF | Chi-Square | Pr > ChiSq |
| CONDITION | 1 | 1.92 | 0.1654 |
| TIME | 5 | 3.18 | 0.6719 |
| CONDITION*TIME | 5 | 7.48 | 0.1872 |

| Contrast Estimate Results |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Label | Estimate | Standard Error | α | Confidence Limits |  | Chi-Square | Pr > ChiSq |
| Condition | -0.3984 | 0.2872 | 0.05 | -0.9614 | 0.1645 | 1.92 | 0.1654 |
| Exp
(Condition) | 0.6714 | 0.1928 | 0.05 | 0.3824 | 1.1788 |  |  |

## Written with inmates
Describes temptations, ease of slipping into the “old life”
Emphasizes the import-ance of making a plan 

**Preventing an Alcohol-exposed Pregnancy after a Jail Term**

- Written with inmates
- Describes temptations, ease of slipping into the “old life”
- Emphasizes the import-ance of making a plan

## Jail-to-Community Transition Assistance

- “One Woman’s Release Story”
- Pre-release community resources group session with an MSW + resources list
- Counseling session 2 emphasized planning for release, taxi voucher
- Release folder: # taxi voucher, copies of materials, reminder cards for post-release sessions
-     +
-      (all) bus tokens, coins for phone,  info on domestic violence & emergency contra-ception; appt cards for interviews; study toll free number, donated personal items

## Transition Planning & Assistance

## Background

- Over half of U.S. pregnancies are unplanned;  among women who drink alcohol at risky levels the rate is higher--???
- Women who stop drinking when they recognize the pregnancy, exposure is still xx-xx weeks; if they wait until they start prenatal care, exposure is xx-xx
*Preconception planning*, emphasized by the Expert Panel on the Content of Prenatal Care, was adopted by CDC FAS prevention scientists x years ago when they planned Project CHOICES, a feasibility study of intervention for women *at risk of* an alcohol-exposed pregnancy

##    Session 2... Discussed Temptation and Confidence profiles for both behaviors

**0**

**1**

**2**

**3**

**4**

**5**

- Using alcohol or

- drugs

- Partner gets upset

- or angry

- Experience side

- effects

- Too much trouble

- With someone other

- than main partner

- Confidence

- Temptation