An Adaptive Reinforcement-Based Treatment (RBT) Intervention …€¦ · · 2016-02-22An Adaptive Reinforcement-Based Treatment (RBT) Intervention for Pregnant Substance Dependent

An Adaptive Reinforcement-Based Treatment (RBT) Intervention for Pregnant

Substance Dependent Women

Michelle Tuten, Ph.D.

Assistant Professor Department of Psychiatry and Behavioral Sciences and

Johns Hopkins University School of Medicine

HIV Methods and Intervention Science Meeting September 12-13th 2013

2

Acknowledgements

National Institute on Drug Abuse

R01DA14979

Participants

Staff at the Center for Addiction and Pregnancy

Hendree Jones (original study PI: slides

adapted from 2011 CPDD workshop)

Collaborators Susan Murphy, Pierre

Alexander, Margaret Chisolm (current PI)

3

Outline

1. Complexities of the Problem

2. Clinical Setting

3. Role of Behavioral Treatment

4. HOME II Study

1. Complexities of the Problem

Alcohol and tobacco substances are the most commonly abused during pregnancy

Minority but significant number of pregnant women (also use) illicit drugs during pregnancy

Drug addiction begins before pregnancy and is the result of complex past and current factors

National Survey on Drug Use

and Health 2008/9

Past Month Use

4

5

1. Complexities of the problem

Pregnancy is a window of opportunity for behavior change

TREATMENT

6

1. Complexities of the problem

Issues Facing Pregnant Drug Users

• Exposure to violence, trauma

• Generational drug use

• Lack of formal education

• Lack of work history or skills

• Legal involvement

• Multiple drug exposure • Limited parenting skills • History of abuse/neglect • Psychiatric issues • Unstable housing • Lack of social support • Medical issues • Nutrition deficits

• Address Barriers to Care

• Improve maternal and infant outcomes

• Conduct clinical research

7

2. Clinical setting

Center for Addiction and Pregnancy mission statement:

Comprehensive Care

• Interdisciplinary approach – Substance abuse

counseling – Psychiatry – Obstetrics – Pediatrics – Nursing

• Multiple modalities

– Medically-assisted withdrawal

– Methadone stabilization

8

2. Clinical setting

No

CAP Treatment (n=100) (n=46)

Clinical measure:

Prenatal visits 8 4

EGA (mean week) 39 35

% positive at delivery 37 63

Infant birth weight (grams) 2934 2539

Apgar scores (1 minute) 8 7

% NICU use 10 26

Length of hospital stay (days) 7 39

All group comparisons are significant: p ≤ .05 (Data adapted from Svikis et al., 1997) 9

2. Clinical setting

Outcome research: cost effectiveness

Investing in CAP drug treatment services resulted in net savings of $4,644 in NICU costs.

Although CAP is cost-

effective, many women continue to drop out of treatment prematurely and/or do not respond to treatment

Guiding Principles

• Drug addiction occurs in absence

of alternative positive reinforcers

• Drug use “makes sense” in that it

meets certain behavioral functions

for the individual

• Drug use behavior can be modified

using operant reinforcement

– Goal of treatment is for non-

drug using behaviors become

more reinforcing than drug

use

10

3. Role of behavioral treatment

Vocational

Assistance/

Job Club

Peer

Support/

Social Club

Functional

Drug Use

Assessment

Behavior

Graphing

Intensive

Outreach

Patient

Personalized

Feedback

Recreational

Activities

Functional assessment (FA)

Personalized feedback (MI adaptation)

Social reinforcement (in the form of weekly Social Club)

Behavior graphing

Vocational assistance/job club

Recreational activities

Intensive outreach

Tangible reinforcers


11

Treatment Elements

Treatment Elements

12

Functional

Assessment (FA) of

drug use

Behavior

Graphing

FA: when, where and

why of drug use

Constellation of

behaviors that compete

with drug use

Graph these target

behaviors


12

Treatment Objectives

Treatment Elements

Treatment

attendance

Recreational

Activities

Vocational

Activities

Medication

compliance

13

Example of Close Behavioral Observation: DRUG FREE DAYS

0

12

3

4

56

7

8

910

11

12

1314

15

1 3 5 7 9 11 13 15

Days

Ab

sti

nen

ce (

yes/n

o)


Allow for connections between

behaviors (if you do this, drug use

occurs, if you do this, drug abstinence

occurs)

Larger goals are broken into

smaller goals

Positive reinforcement given

for successes

Good

Job!

Good

Job!

Nu

mb

er

of

Ap

pli

cati

on

s

14

0

2

4

6

8

10

12

14

16

wee

k 1

wee

k 2

wee

k 3

wee

k 4

Number of Job

Applications

Example Of Behavior Tracking

_______________

Employment

obtained

Goal= 9

applications/week


15 15

Examples: Participant Treatment Progress

D

ays D

rug F

ree


0

20

40

60

80

100

RBT Control

Opioid and Cocaine Negative

0

20

40

60

80

100

1-month 3-month 1-month 3-month%

Po

siti

ve U

rin

e S

amp

les

RBT (n=72)

Control (n=128)

16 16

*

Opioids Cocaine


(Gruber et al., 2000; Jones et al., 2005; Jones 2011; Tuten et al., 2012 * All treatment condition comparisons

are significant at p ≤ .05

3 randomized trials showing

RBT’s efficacy in nonpregnant

patients (1 month, 6 months, 12

months follow-up)

1RBT adaptation and test in

pregnant patients

As with any intervention, not all

RBT-treated participants

attended treatment or reduced

drug use, suggesting room to

improve patient response

0

20

40

60

80

100

RBT Control

Opioid and Cocaine Negative

0

20

40

60

80

100

RBT UC

Me

an D

ays

Delivery

*

*

*

*

* *

17


We identified two important questions regarding RBT

for pregnant women:

Would variants of RBT in terms of their intensity and

scope be effective?

Would patients who differed in terms of their treatment

compliance be differentially responsive to these variants

of RBT?

18

4. A SMART trial at HOME

Inclusion Criteria:

Evidence of cocaine and/or opiate use

Treatment entry at or before 32 weeks EGA with singleton fetus

Completion of the eight-day residential detoxification stay Exclusion Criteria:

Age 17 or younger

Geographical Constraints

Severe medical or psychiatric concomitant condition interfering with treatment or needing hospitalization

HOME II Eligibility Criteria

19

• Birth weight

• Head Circumference

• Length of Hospital/NICU Stay

• Urine Toxicology at Delivery

• Physical Birth Parameters

• Neonatal Complications

Primary Outcomes- Maternal: Treatment Completion (Delivery)

Heroin Use

Cocaine Use

Secondary Outcomes- Neonatal :


Decisions for Designing the Trial:

How to choose a design structure to answer

questions of interest:

Initial randomization conditions?

Second randomization to what?

Which treatment response characteristics:

Was strongly related to outcome?

Would allow reasonable tailoring?

Length of time to allow for assessment of the

tailoring variable

Pregnancy time-limited window

Solutions:

Initial Randomization: Compare

TAU RBT to a potentially more cost

effective form of RBT intervention

Treatment Compliance as the

tailoring variable: Failure to comply

with treatment soon after treatment

entry the biggest reason for failure to

complete treatment

Assess compliance during the first

two weeks following treatment

entry

20


21

• HOME II intervention adjusts in intensity or scope following patients’ initial treatment compliance or non-compliance.

• It is expected that RBT in an adaptive intervention format will optimize maternal treatment outcomes for both early compliant and early non-compliant participants by matching treatment to patient needs.

Planned Sample Size 4. A SMART trial at HOME

22

tRBT: Treatment-as-usual RBT

• All elements of treatment-as-usual RBT

rRBT: reduced RBT

– Key RBT elements are provided at a reduced scope to examine a version of RBT that might be more in line with community practice limitations

All

non-methadone

CAP Patients

tRBT

rRBT

Random

Assignment

5X/week: Individual sessions

3X/week: Recreation

3X/week: Job Club

3X/week: Individual sessions

1X/week: Recreation

1X/week: Job Club


23

Tailored Treatment Randomization

Two-week window for treatment response

• Early compliant participants

randomized to either the same intensity of treatment or a decreased intensity or scope of RBT treatment

• Early non-compliant participants randomized to receive either the same treatment or a greater intensity or scope of RBT

Early treatment non-compliance:

(a) a missed unexcused treatment day,

(b) a positive opioid or cocaine urine specimen,

(c) or self-report of use of either drug.


24

Increased intensity

eRBT: Enhanced RBT

All tRBT elements, plus:

Home visits to re-engage participant/deliver

therapy

Immediate re-admission to the residential

unit or community recovery housing as “time

out” from drug use

Decreased intensity

aRBT: Abbreviated RBT

Most reduced version of RBT:

Graphing drug abstinence

Outreach limited to follow-up call

Individual sessions once a week

Recreation and social club once a month


25

Primary Aim:

Relative efficacy of providing

continued treatment-as-usual RBT in comparison to continued reduced RBT to both early-compilers and early non-

compliers throughout the trial.

►Addresses the question of whether it is necessary to provide treatment-as-usual RBT, or if it is possible to

successfully treat patients with reduced RBT, regardless of the

patient’s level of compliance.


26

Secondary Aims:

Early non-compliers: Relative efficacy

of transitioning to a more intensive level of treatment for the TAU RBT and the reduced RBT conditions.

►Answers questions regarding the

relative importance of the initial level of care in determining the efficacy of transitioning to a higher level of care

for early-non compliers.


27

Secondary Aims (cont.):

Early-compliers: relative efficacy of

transitioning to a less intense level of treatment for within the initial TAU RBT and reduced RBT treatment

conditions.

►Answers questions about the importance of the initial level of RBT treatment in determining success in

subsequently reducing the level of RBT treatment in early-compliers.


28

Secondary Aims (cont.):

Relative efficacy for early-complier and

early-non-compliers who begin and continue in treatment-as-usual RBT or who begin and continue in reduced

RBT, respectively.

►Answers the question about the relative decrement in treatment success that occurs as a result of an

early failure to comply with the initial demands of treatment.


Decrease

Intensity Decrease

Scope

All non-methadone CAP Patients

N= 230

tRBT n =114

rRBT

n =116

Early

Compliant n=48

Early

Non- Compliant

n=61

tRBT

n=30

Early

Non- Compliant

n=53

Early

Compliant n=56

rRBT

n=28

aRBT

n=28

rRBT

n=24

tRBT

n=24

tRBT

n=26

rRBT n=27

eRBT

n=31

Tailoring Variable Randomization:

Treatment Compliance

Random Assignment

Increase

Intensity

Increase

Scope

29

Current Enrollment


30

Challenges in Conducting the Trial

• Recruitment

• Participant adherence to assessment protocol • Maintenance of distinct treatment conditions

• Adherence of the clinical staff to the protocol

• Changing clinical programming

New Insights Resulting from the Trial

• Patient acceptance of the tailoring treatment randomization

• Better-than-expected distribution of patients into tailoring treatment randomization


31 31

What we’ve learned from process:

• Feasible and desirable

• Well-defined tailoring/response definitions

• Distinct and theoretically sound conditions

• Procedures to maintain conditions (and documented deviations)

4. A SMART trial at HOME: SUMMARY

An Adaptive Reinforcement-Based Treatment (RBT) Intervention …€¦ · · 2016-02-22An Adaptive Reinforcement-Based Treatment (RBT) Intervention for Pregnant Substance Dependent

Documents