Trial Outcomes & Findings for Mobile Continuing Care Approach for Youth (NCT NCT01632735)
NCT ID: NCT01632735
Last Updated: 2015-08-21
Results Overview
Primary substance use relapse was measured by urine tests (0 = negative, 1 = positive).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
80 participants
Primary outcome timeframe
Baseline, discahrge, 3 month follow-up, 6 month follow-up, 9 month follow-up
Results posted on
2015-08-21
Participant Flow
Participant milestones
| Measure |
Mobile Continuing Care
Behavioral: 12-week Structured Texting intervention focused on recovery monitoring, feedback for self-management, social support and education
Mobile Continuing Care: Behavioral: Mobile Texting 12-week intervention. Delivers daily recovering monitoring, self-management feedback, and education/social support
|
Standard Continuing Care as Usual
Continuing care as usual (12-step facilitation) group
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
COMPLETED
|
36
|
37
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mobile Continuing Care Approach for Youth
Baseline characteristics by cohort
| Measure |
Mobile Continuing Care
n=40 Participants
Behavioral: 12-week Structured Texting intervention focused on recovery monitoring, feedback for self-management, social support and education
Mobile Continuing Care: Behavioral: Mobile Texting 12-week intervention. Delivers daily recovering monitoring, self-management feedback, and education/social support
|
Standard Continuing Care as Usual
n=40 Participants
Continuing care as usual (12-step facilitation) group
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
22.1 years
STANDARD_DEVIATION 3.1 • n=5 Participants
|
19.0 years
STANDARD_DEVIATION 3.1 • n=7 Participants
|
20.4 years
STANDARD_DEVIATION 3.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
10 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=5 Participants
|
40 participants
n=7 Participants
|
80 participants
n=5 Participants
|
|
education
|
14.0 years
STANDARD_DEVIATION 2.3 • n=5 Participants
|
12.0 years
STANDARD_DEVIATION 2.0 • n=7 Participants
|
12.9 years
STANDARD_DEVIATION 2.9 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, discahrge, 3 month follow-up, 6 month follow-up, 9 month follow-upPopulation: An intent to treat model was used. The primary outcome measure is primary substance use measured by urine drug test at baseline, discharge as well as at 3-, 6-, and 9-month follow-ups. Study retention at discharge was 95%, 92.5% at 3 months, 86.2% at 6 months, and 82.5% at 9 months.
Primary substance use relapse was measured by urine tests (0 = negative, 1 = positive).
Outcome measures
| Measure |
Mobile Continuing Care
n=40 Participants
Behavioral: 12-week Structured Texting intervention focused on recovery monitoring, feedback for self-management, social support and education
Mobile Continuing Care: Behavioral: Mobile Texting 12-week intervention. Delivers daily recovering monitoring, self-management feedback, and education/social support
|
Standard Continuing Care as Usual
n=40 Participants
Continuing care as usual (12-step facilitation) group
|
|---|---|---|
|
Primary Substance Use (Defined as Substance Received Treatment for)
baseline substance use
|
47.5 percentage of positive urines
|
41.5 percentage of positive urines
|
|
Primary Substance Use (Defined as Substance Received Treatment for)
discharge substace use
|
14.7 percentage of positive urines
|
62.9 percentage of positive urines
|
|
Primary Substance Use (Defined as Substance Received Treatment for)
3-month follow-up substace use
|
21.4 percentage of positive urines
|
59.3 percentage of positive urines
|
|
Primary Substance Use (Defined as Substance Received Treatment for)
6-month follow-up substace use
|
16.7 percentage of positive urines
|
50.0 percentage of positive urines
|
|
Primary Substance Use (Defined as Substance Received Treatment for)
9-month follow-up substace use
|
11.1 percentage of positive urines
|
14.3 percentage of positive urines
|
SECONDARY outcome
Timeframe: baseline, discharge, 3-, 6- and 9-month follow-upsPopulation: Intent to treatment model was used. Mixed modeling used to examine differences in recovery behaviors (measured by mean days doing extracurricular/recovery-goal directed activities) over time between study conditions.
Recovery behaviors defined as mean number of days doing extracurricular/recovery-goal directed activities using repeated measures over time.
Outcome measures
| Measure |
Mobile Continuing Care
n=40 Participants
Behavioral: 12-week Structured Texting intervention focused on recovery monitoring, feedback for self-management, social support and education
Mobile Continuing Care: Behavioral: Mobile Texting 12-week intervention. Delivers daily recovering monitoring, self-management feedback, and education/social support
|
Standard Continuing Care as Usual
n=40 Participants
Continuing care as usual (12-step facilitation) group
|
|---|---|---|
|
Participation in Recovery Behaviors Over Time
baseline recovery behaviors
|
12.1 days per month
Standard Deviation 9.7
|
14.5 days per month
Standard Deviation 11.7
|
|
Participation in Recovery Behaviors Over Time
discharge recovery behaviors
|
17.3 days per month
Standard Deviation 8.5
|
10.3 days per month
Standard Deviation 11.4
|
|
Participation in Recovery Behaviors Over Time
3-month recovery behaviors
|
14.5 days per month
Standard Deviation 9.5
|
11.97 days per month
Standard Deviation 11.96
|
|
Participation in Recovery Behaviors Over Time
6-month recovery behaviors
|
17.5 days per month
Standard Deviation 10.6
|
13.8 days per month
Standard Deviation 12.9
|
|
Participation in Recovery Behaviors Over Time
9-month recovery behaviors
|
18.4 days per month
Standard Deviation 10.6
|
12.4 days per month
Standard Deviation 16.6
|
SECONDARY outcome
Timeframe: baseline, discharge, 3-, 6-, and 9-month follow-upsPopulation: Used an intent to treat design. Examined the effects of the intervention (mobile continuing care) compared to aftercare as usual on change in recovery self-confidence over time.
Change/improvements in mean recovery confidence score over time (measured by question "How confident are you in your ability to be completely abstinent (clean) from alcohol and drugs in the next 30 days?" (units on scale included 0=not at all, 1=slightly, 2=moderately, 3=considerably, 4-extremely).
Outcome measures
| Measure |
Mobile Continuing Care
n=40 Participants
Behavioral: 12-week Structured Texting intervention focused on recovery monitoring, feedback for self-management, social support and education
Mobile Continuing Care: Behavioral: Mobile Texting 12-week intervention. Delivers daily recovering monitoring, self-management feedback, and education/social support
|
Standard Continuing Care as Usual
n=40 Participants
Continuing care as usual (12-step facilitation) group
|
|---|---|---|
|
Recovery Confidence (Self-efficacy) Over Time
baseline confidence rating
|
2.40 units on a scale
Standard Deviation 1.3
|
2.53 units on a scale
Standard Deviation 1.2
|
|
Recovery Confidence (Self-efficacy) Over Time
discharge confidence rating
|
2.73 units on a scale
Standard Deviation 1.03
|
2.57 units on a scale
Standard Deviation 1.5
|
|
Recovery Confidence (Self-efficacy) Over Time
3-month follow-up confidence rating
|
2.67 units on a scale
Standard Deviation 1.3
|
2.43 units on a scale
Standard Deviation 1.4
|
|
Recovery Confidence (Self-efficacy) Over Time
6-month follow-up confidence rating
|
3.20 units on a scale
Standard Deviation 1.02
|
2.51 units on a scale
Standard Deviation 1.50
|
|
Recovery Confidence (Self-efficacy) Over Time
9-month follow-up confidence rating
|
2.85 units on a scale
Standard Deviation 1.3
|
2.73 units on a scale
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: Baseline, discahrge, 3 month follow-up, 6 month follow-up, 9 month follow-upPopulation: Intent to treat model was used to assess the effects of the intervention (mobile continuing care) compared to aftercare as usual in terms of improvements in social support service utilization over time (baseline, discharge and follow-ups: 3-, 6- and 9-months post-discharge).
Self-help utilization was measured by the question: "In the past 30 days, how many days did you attend self-help meetings like AA or NA to support your recovery?"
Outcome measures
| Measure |
Mobile Continuing Care
n=40 Participants
Behavioral: 12-week Structured Texting intervention focused on recovery monitoring, feedback for self-management, social support and education
Mobile Continuing Care: Behavioral: Mobile Texting 12-week intervention. Delivers daily recovering monitoring, self-management feedback, and education/social support
|
Standard Continuing Care as Usual
n=40 Participants
Continuing care as usual (12-step facilitation) group
|
|---|---|---|
|
Social Support Utilization
9-month upport utilization
|
4.9 days per month
Standard Deviation 7.7
|
2.8 days per month
Standard Deviation 7.2
|
|
Social Support Utilization
baseline social support utilization
|
12.8 days per month
Standard Deviation 10.3
|
9.8 days per month
Standard Deviation 8.1
|
|
Social Support Utilization
discharge social support utilization
|
8.6 days per month
Standard Deviation 10.1
|
2.8 days per month
Standard Deviation 6.6
|
|
Social Support Utilization
3-month follow-up social support utilization
|
7.4 days per month
Standard Deviation 9.5
|
2.4 days per month
Standard Deviation 6.0
|
|
Social Support Utilization
6-month upport utilization
|
6.1 days per month
Standard Deviation 8.5
|
2.8 days per month
Standard Deviation 7.3
|
Adverse Events
Mobile Continuing Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Continuing Care as Usual
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place