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Screening to Augment Referral to Treatment- Project START (ProjectSTART)

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ClinicalTrials.gov Identifier: NCT01539525
Recruitment Status : Completed
First Posted : February 27, 2012
Results First Posted : April 14, 2017
Last Update Posted : April 14, 2017
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Kimberly Yonkers, Yale University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Alcohol Abuse
Tobacco Use Disorder
Marijuana Abuse
Substance-Related Disorders
Interventions Behavioral: Motivational Interview
Other: Treatment as Usual
Enrollment 439
Recruitment Details Participants were women (non-pregnant and pregnant) presenting for outpatient reproductive healthcare in an urban academic hospital-based clinic. Data collection occurred between April 20, 2011 and January 28, 2015.
Pre-assignment Details  
Arm/Group Title Motivational Interview-Nurse Motivational Interview-Computer Treatment as Usual
Hide Arm/Group Description

Motivational interview provided by a clinical research nurse or physician.

Motivational Interview: Motivational Interview provided by either a Nurse or Computer

Motivational Interview provided by an interactive computer program.

Motivational Interview: Motivational Interview provided by either a Nurse or Computer

No intervention- resource list provided.

Resource brochure: Subjects given a brochure listing relevant recovery resources in the local area.

Period Title: Overall Study
Started 145 143 151
Completed 125 127 134
Not Completed 20 16 17
Reason Not Completed
Lost to Follow-up             19             12             11
Withdrawal by Subject             0             3             2
Protocol Violation             1             1             4
Arm/Group Title Motivational Interview Motivational Interview-Electronic Treatment as Usual Total
Hide Arm/Group Description

Motivational interview provided by a clinical research nurse or physician.

Motivational Interview: Motivational Interview provided by either a Nurse or Computer

Motivational Interview provided by an interactive computer program.

Motivational Interview: Motivational Interview provided by either a Nurse or Computer

No intervention- resource list provided.

Resource brochure: Subjects given a brochure listing relevant recovery resources in the local area.

Total of all reporting groups
Overall Number of Baseline Participants 145 143 151 439
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 145 participants 143 participants 151 participants 439 participants
33.6  (109) 34.6  (10.3) 34.4  (12.0) 34.2  (11.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 145 participants 143 participants 151 participants 439 participants
Female
145
 100.0%
143
 100.0%
151
 100.0%
439
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 145 participants 143 participants 151 participants 439 participants
Afican-American, non-Hispanic 102 93 98 293
Caucasian-American, non-Hispanic 19 16 23 58
Hispanic 19 22 24 65
Other race/ethnicity 5 12 6 23
Marital Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 145 participants 143 participants 151 participants 439 participants
Married/living with partner 70 54 73 197
Other living situation 75 89 78 242
Pregnant  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 145 participants 143 participants 151 participants 439 participants
Pregnant 27 24 29 80
Not pregnant 118 119 122 359
Education  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 145 participants 143 participants 151 participants 439 participants
Some high school or less 46 48 52 146
High school graduate 64 60 57 181
Beyond high school 35 33 42 110
missing 0 2 0 2
Employment status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 145 participants 143 participants 151 participants 439 participants
Full-time 18 28 20 66
Part-time 24 26 32 82
Not working 103 89 99 291
Primary Substance  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 145 participants 143 participants 151 participants 439 participants
Nicotine 81 80 90 251
Alcohol 15 23 13 51
Cannabis 32 27 31 90
Other illicit drug 17 13 17 47
Primary substance use  
Mean (Standard Deviation)
Unit of measure:  Days per month
Number Analyzed 145 participants 143 participants 151 participants 439 participants
23.2  (8.3) 23.7  (7.7) 24.2  (7.7) 23.7  (7.9)
Any substance use  
Mean (Standard Deviation)
Unit of measure:  Days per month
Number Analyzed 145 participants 143 participants 151 participants 439 participants
26.0  (5.5) 25.4  (6.2) 25.7  (6.1) 25.7  (5.9)
Substance Use Disorders  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 145 participants 143 participants 151 participants 439 participants
Nicotine 81 80 90 251
Alcohol 15 23 13 51
Cannabis 32 27 31 90
Other illicit drug 17 13 17 47
Alcohol, Smoking, and Substance Involvement Screening Test Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 145 participants 143 participants 151 participants 439 participants
22.5  (8.1) 22.8  (8.5) 22.2  (8.1) 22.5  (7.9)
[1]
Measure Description: Scores range from 0 to 39, with higher scores indicating greater need for more intensive intervention. Scores are for primary substance.
Fagerstrom Test for Nicotine Dependence Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 145 participants 143 participants 151 participants 439 participants
3.8  (2.7) 3.6  (2.8) 3.9  (2.7) 3.9  (2.6)
[1]
Measure Description: Scores range from 0 to 10, with higher scores indicating higher levels of nicotine dependence.
1.Primary Outcome
Title Days Per Month of Primary Substance Use
Hide Description Participants completed a timeline followback at each assessment, reporting days of primary substance use. Outcomes reported are raw means and standard deviations.
Time Frame 7 non-overlapping monthly intervals from baseline to month 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Motivational Interview-Nurse Motivational Interview-Computer Treatment as Usual
Hide Arm/Group Description:

Motivational interview provided by a clinical research nurse or physician.

Motivational Interview: Motivational Interview provided by either a Nurse or Computer

Motivational Interview provided by an interactive computer program.

Motivational Interview: Motivational Interview provided by either a Nurse or Computer

No intervention- resource list provided.

Resource brochure: Subjects given a brochure listing relevant recovery resources in the local area.

Overall Number of Participants Analyzed 145 143 151
Mean (Standard Deviation)
Unit of Measure: days per month
baseline 23.2  (8.3) 23.7  (7.7) 24.2  (7.7)
Month 1 19.3  (11.2) 19.7  (11.2) 22.8  (8.9)
Month 2 18.7  (11.8) 17.9  (12.1) 22.2  (10.1)
Month 3 18.0  (12.0) 17.8  (11.9) 21.4  (10.6)
Month 4 18.0  (12.2) 16.8  (12.3) 20.0  (11.4)
Month 5 17.6  (12.5) 16.3  (12.6) 19.7  (11.4)
Month 6 17.0  (12.3) 16.2  (12.5) 19.1  (11.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Motivational Interview-Nurse, Motivational Interview-Computer, Treatment as Usual
Comments Differences in days/month of primary substance use over time between treatment groups were examined using generalized estimating equations (GEE). We specified a negative binomial distribution to account for overdispersion in days/month of primary substance use, a log link function, and a first-order autoregressive working correlation structure. β coefficients were estimated using quasi-likelihood estimation methods and sandwich/empirical standard errors were calculated.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Generalized Estimating Equation
Comments adjusted for stratifying variables- primary substance and pregnancy status
Method of Estimation Estimation Parameter Slope
Estimated Value -0.078
Confidence Interval (2-Sided) 95%
-0.118 to -0.038
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.020
Estimation Comments Parameter estimated is the linear effect of time (in months)
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Motivational Interview-Nurse, Motivational Interview-Computer, Treatment as Usual
Comments Differences in days/month of primary substance use over time between treatment groups were examined using generalized estimating equations (GEE). We specified a negative binomial distribution to account for overdispersion in days/month of primary substance use, a log link function, and a first-order autoregressive working correlation structure. β coefficients were estimated using quasi-likelihood estimation methods and sandwich/empirical standard errors were calculated.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.066
Comments [Not Specified]
Method Generalized Estimating Equation
Comments adjusted for stratifying variables- primary substance and pregnancy status
Method of Estimation Estimation Parameter Slope
Estimated Value 0.005
Confidence Interval (2-Sided) 95%
-0.0004 to 0.011
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.003
Estimation Comments Parameter estimated is the quadratic effect of time (in months)
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Motivational Interview-Nurse, Motivational Interview-Computer, Treatment as Usual
Comments Differences in days/month of primary substance use over time between treatment groups were examined using generalized estimating equations (GEE). We specified a negative binomial distribution to account for overdispersion in days/month of primary substance use, a log link function, and a first-order autoregressive working correlation structure. β coefficients were estimated using quasi-likelihood estimation methods and sandwich/empirical standard errors were calculated.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.038
Comments P-value adjusted for multiple comparisons using Holm’s step-down multiple testing procedure. The a priori threshold for statistical significance was p < 0.05.
Method Generalized Estimating Equation
Comments adjusted for stratifying variables- primary substance and pregnancy status
Method of Estimation Estimation Parameter Slope
Estimated Value -0.078
Confidence Interval (2-Sided) 95%
-0.151 to -0.004
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.034
Estimation Comments Estimated parameter is treatment x linear time interaction term coefficient- Motivational Interview- Nurse vs. Treatment as Usual
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Motivational Interview-Nurse, Motivational Interview-Computer, Treatment as Usual
Comments Differences in days/month of primary substance use over time between treatment groups were examined using generalized estimating equations (GEE). We specified a negative binomial distribution to account for overdispersion in days/month of primary substance use, a log link function, and a first-order autoregressive working correlation structure. β coefficients were estimated using quasi-likelihood estimation methods and sandwich/empirical standard errors were calculated.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments P-value adjusted for multiple comparisons using Holm’s step-down multiple testing procedure. The a priori threshold for statistical significance was p < 0.025
Method Generalized Estimating Equation
Comments adjusted for stratifying variables- primary substance and pregnancy status
Method of Estimation Estimation Parameter Slope
Estimated Value -0.090
Confidence Interval (2-Sided) 95%
-0.157 to -0.023
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.034
Estimation Comments Estimated parameter is treatment x linear time interaction term coefficient- Motivational Interview- Computer vs. Treatment as Usual
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Motivational Interview-Nurse, Motivational Interview-Computer, Treatment as Usual
Comments Differences in days/month of primary substance use over time between treatment groups were examined using generalized estimating equations (GEE). We specified a negative binomial distribution to account for overdispersion in days/month of primary substance use, a log link function, and a first-order autoregressive working correlation structure. β coefficients were estimated using quasi-likelihood estimation methods and sandwich/empirical standard errors were calculated.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.031
Comments P-value adjusted for multiple comparisons using Holm’s step-down multiple testing procedure. The a priori threshold for statistical significance was p < 0.05.
Method Generalized Estimating Equation
Comments adjusted for stratifying variables- primary substance and pregnancy status
Method of Estimation Estimation Parameter Slope
Estimated Value 0.011
Confidence Interval (2-Sided) 95%
0.001 to 0.022
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.005
Estimation Comments Estimated parameter is treatment x quadratic time interaction term coefficient- Motivational Interview- Nurse vs. Treatment as Usual
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Motivational Interview-Nurse, Motivational Interview-Computer, Treatment as Usual
Comments Differences in days/month of primary substance use over time between treatment groups were examined using generalized estimating equations (GEE). We specified a negative binomial distribution to account for overdispersion in days/month of primary substance use, a log link function, and a first-order autoregressive working correlation structure. β coefficients were estimated using quasi-likelihood estimation methods and sandwich/empirical standard errors were calculated.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.010
Comments P-value adjusted for multiple comparisons using Holm’s step-down multiple testing procedure. The a priori threshold for statistical significance was p < 0.025.
Method Generalized Estimating Equation
Comments adjusted for stratifying variables- primary substance and pregnancy status
Method of Estimation Estimation Parameter Slope
Estimated Value 0.012
Confidence Interval (2-Sided) 95%
0.002 to 0.021
Parameter Dispersion
Type: Standard Error of the Mean
Value: .0005
Estimation Comments Estimated parameter is treatment x quadratic time interaction term coefficient- Motivational Interview- Computer vs. Treatment as Usual
2.Primary Outcome
Title Treatment Utilization
Hide Description Treatment utilization assessed via participant self-report at each follow-up interview, and with the exception of self-help groups, verified with providers. We also reviewed the medical record for use of medication indicative of treatment (e.g., nicotine replacement therapy).
Time Frame baseline to 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Motivational Interview-Nurse Motivational Interview-Computer Treatment as Usual
Hide Arm/Group Description:

Motivational interview provided by a clinical research nurse or physician.

Motivational Interview: Motivational Interview provided by either a Nurse or Computer

Motivational Interview provided by an interactive computer program.

Motivational Interview: Motivational Interview provided by either a Nurse or Computer

No intervention- resource list provided.

Resource brochure: Subjects given a brochure listing relevant recovery resources in the local area.

Overall Number of Participants Analyzed 145 143 151
Measure Type: Number
Unit of Measure: participants
utilized treatment 39 39 43
no tretment 106 104 108
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Motivational Interview-Nurse, Motivational Interview-Computer, Treatment as Usual
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.810
Comments [Not Specified]
Method Regression, Logistic
Comments adjusted for stratifying variables- primary substance and pregnancy status
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.931
Confidence Interval (2-Sided) 95%
0.559 to 1.551
Estimation Comments Estimated odds ratio is for Motivational Interview- Nurse vs. Treatment as Usual
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Motivational Interview-Nurse, Motivational Interview-Computer, Treatment as Usual
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.990
Comments [Not Specified]
Method Regression, Logistic
Comments adjusted for stratifying variables- primary substance and pregnancy status
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.968
Confidence Interval (2-Sided) 95%
0.579 to 1.617
Estimation Comments Estimated odds ratio is for Motivational Interview- Computer vs. Treatment as Usual
3.Secondary Outcome
Title Rates of STDs
Hide Description rates of incident std's per patient's medical records
Time Frame baseline to 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Motivational Interview-Nurse Motivational Interview-Computer Treatment as Usual
Hide Arm/Group Description:

Motivational interview provided by a clinical research nurse or physician.

Motivational Interview: Motivational Interview provided by either a Nurse or Computer

Motivational Interview provided by an interactive computer program.

Motivational Interview: Motivational Interview provided by either a Nurse or Computer

No intervention- resource list provided.

Resource brochure: Subjects given a brochure listing relevant recovery resources in the local area.

Overall Number of Participants Analyzed 145 143 151
Measure Type: Number
Unit of Measure: participants
Incident case 8 4 6
Non-incident case 135 138 152
Missing 2 1 3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Motivational Interview-Nurse, Motivational Interview-Computer, Treatment as Usual
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.465
Comments [Not Specified]
Method Regression, Logistic
Comments adjusted for stratifying variables- primary drug and pregnancy status
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.258
Confidence Interval (2-Sided) 95%
0.409 to 3.871
Estimation Comments odds ratio estimate is for Motivational Interview- Nurse vs. Treatment as Usual
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Motivational Interview-Nurse, Motivational Interview-Computer, Treatment as Usual
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.490
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.749
Confidence Interval (2-Sided) 95%
0.205 to 2.732
Estimation Comments Odds ratio estimate is for Motivational Interview- Computer vs. Treatment as Usual
4.Secondary Outcome
Title Mean Cost for Each Intervention
Hide Description The data table includes the mean cost for implementation of each intervention from the societal perspective. The costs do not include the research costs
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This outcome was restricted to participants who had a time stamp for their intervention (n=11 were missing) and had all 6 months of follow-up data.
Arm/Group Title Motivational Interview Motivational Interview-Electronic Treatment as Usual
Hide Arm/Group Description:

Motivational interview provided by a clinical research nurse or physician.

Motivational Interview: Motivational Interview provided by either a Nurse or Computer

Motivational Interview provided by an interactive computer program.

Motivational Interview: Motivational Interview provided by either a Nurse or Computer

No intervention- resource list provided.

Treatment as Usual: Subjects given a brochure listing relevant recovery resources in the local area.

Overall Number of Participants Analyzed 115 123 133
Mean (Standard Deviation)
Unit of Measure: dollars
57.56  (16.12) 21.07  (4.43) 21.21  (7.3)
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Motivational Interview Motivational Interview-Electronic Treatment as Usual
Hide Arm/Group Description

Motivational interview provided by a clinical research nurse or physician.

Motivational Interview: Motivational Interview provided by either a Nurse or Computer

Motivational Interview provided by an interactive computer program.

Motivational Interview: Motivational Interview provided by either a Nurse or Computer

No intervention- resource list provided.

Resource brochure: Subjects given a brochure listing relevant recovery resources in the local area.

All-Cause Mortality
Motivational Interview Motivational Interview-Electronic Treatment as Usual
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Motivational Interview Motivational Interview-Electronic Treatment as Usual
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/145 (0.00%)   0/143 (0.00%)   0/151 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Motivational Interview Motivational Interview-Electronic Treatment as Usual
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/145 (0.00%)   0/143 (0.00%)   0/151 (0.00%) 

Results may not be generalizable to populations differing from population from which sample was drawn.

Outcomes relied upon self-report, although we did try to verify through lab results for substance use and medical records/ provider for treatment.

Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Kimberly A Yonkers
Organization: Yale University School of Medicine
Phone: 203-764-6621
Responsible Party: Kimberly Yonkers, Yale University
ClinicalTrials.gov Identifier: NCT01539525     History of Changes
Other Study ID Numbers: 1005006785
R01DA027194 ( U.S. NIH Grant/Contract )
First Submitted: August 3, 2011
First Posted: February 27, 2012
Results First Submitted: September 29, 2016
Results First Posted: April 14, 2017
Last Update Posted: April 14, 2017