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Adolescents With Substance Use Disorders Transitioníng From Residential Treatment to the Community

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ClinicalTrials.gov Identifier: NCT03592186
Recruitment Status : Completed
First Posted : July 19, 2018
Results First Posted : December 11, 2020
Last Update Posted : January 21, 2022
Sponsor:
Collaborators:
Rhode Island Hospital
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Brown University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions Substance Use
Adolescent Behavior
Interventions Behavioral: Parenting Wisely+
Behavioral: Treatment as Usual
Enrollment 122
Recruitment Details

74 participants (37 dyads) were recruited from a short-term residential facility and 48 participants (24 dyads) were recruited from a long-term facility.

The long-term facility was added in Year 3 of the trial to improve recruitment and inform design of a fully powered trial (consistent with recruitment plan outlined in the grant proposal).

Pre-assignment Details Following informed consent, participants had to complete a baseline assessment and confirm discharge to parental custody (study inclusion criteria) before randomization. 10 participants (5 dyads) that consented were not randomized and not included in the final intent-to-treat sample because of these inclusion criteria.
Arm/Group Title Parenting Wisely+ Treatment as Usual
Hide Arm/Group Description

Parenting Wisely+ consists of access to the Parenting Wisely computer program (www.parentingwisely.com), paired with engagement strategies: up to four in-person coaching sessions, daily text messages, and access to an online networking forum.

Parenting Wisely+: Parenting Wisely+ consists of access to the Parenting Wisely computer program, paired with engagement strategies: up to four parent coaching sessions, daily text messages, and access to an online networking forum

Treatment as Usual: The active comparator is residential treatment as usual

The active comparator is defined as residential treatment services as usual.

Treatment as Usual: The active comparator is residential treatment as usual

Period Title: Overall Study
Number of participants Number of units (Dyads (adolescent + parent)) Number of participants Number of units (Dyads (adolescent + parent))
Started 60 30 62 31
6-week Follow-up [1] 49 25 56 29
12-week Follow-up [2] 47 27 51 27
Completed [3] 43 24 51 27
Not Completed 17 6 11 4
Reason Not Completed
Withdrawal by Subject             1                         0            
Lost to Follow-up             16                         11            
[1]
At 6-week follow-up, 25 PW+ dyads (25 parents, 24 teens) and 29 TAU dyads (29 parents, 27 teens)
[2]
At 12-week follow-up, 27 PW+ dyads (25 parents, 22 teens) and 27 TAU dyads (26 parents, 25 teens)
[3]
At 24-week (final), 24 PW+ dyads (23 parents, 20 teens) and 27 TAU dyads (25 parents, 26 teens).
Arm/Group Title Parenting Wisely+ Treatment as Usual Total
Hide Arm/Group Description

Parenting Wisely+ consists of access to the Parenting Wisely computer program (www.parentingwisely.com), paired with engagement strategies: up to four in-person coaching sessions, daily text messages, and access to an online networking forum.

Parenting Wisely+: Parenting Wisely+ consists of access to the Parenting Wisely computer program, paired with engagement strategies: up to four parent coaching sessions, daily text messages, and access to an online networking forum

Treatment as Usual: The active comparator is residential treatment as usual

The active comparator is defined as residential treatment services as usual.

Treatment as Usual: The active comparator is residential treatment as usual

Total of all reporting groups
Overall Number of Baseline Participants 60 62 122
Hide Baseline Analysis Population Description
Total number of participants was 122. Analyses were conducted using 61 adolescent-parent dyads, since adolescent and parent data were not independent
Age, Customized   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Parent age Number Analyzed 30 participants 31 participants 61 participants
43.93  (6.52) 41.23  (6.75) 42.56  (6.72)
Teen age Number Analyzed 30 participants 31 participants 61 participants
15.80  (0.93) 15.61  (1.12) 15.7  (1.02)
[1]
Measure Analysis Population Description: Row population differs from Overall, because age was separately calculated for parents and teens.
Sex/Gender, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Teen Female Number Analyzed 60 participants 62 participants 122 participants
15
  25.0%
17
  27.4%
32
  26.2%
Teen Male Number Analyzed 60 participants 62 participants 122 participants
13
  21.7%
14
  22.6%
27
  22.1%
Teen Other / Prefer not to answer Number Analyzed 60 participants 62 participants 122 participants
2
   3.3%
0
   0.0%
2
   1.6%
Parent Female Number Analyzed 60 participants 62 participants 122 participants
26
  43.3%
24
  38.7%
50
  41.0%
Parent Male Number Analyzed 60 participants 62 participants 122 participants
4
   6.7%
7
  11.3%
11
   9.0%
Parent Other / Prefer not to answer Number Analyzed 60 participants 62 participants 122 participants
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Teen Ethnicity Number Analyzed 30 participants 31 participants 61 participants
Hispanic or Latino
10
  33.3%
6
  19.4%
16
  26.2%
Not Hispanic or Latino
20
  66.7%
25
  80.6%
45
  73.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Parent Ethnicity Number Analyzed 30 participants 31 participants 61 participants
Hispanic or Latino
8
  26.7%
2
   6.5%
10
  16.4%
Not Hispanic or Latino
22
  73.3%
29
  93.5%
51
  83.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Analysis Population Description: Each row separately reports on ethnicity for parents and teens.
Race (NIH/OMB)   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Teen Race Number Analyzed 30 participants 31 participants 61 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   3.2%
1
   1.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
  10.0%
4
  12.9%
7
  11.5%
White
21
  70.0%
14
  45.2%
35
  57.4%
More than one race
1
   3.3%
8
  25.8%
9
  14.8%
Unknown or Not Reported
5
  16.7%
4
  12.9%
9
  14.8%
Parent Race Number Analyzed 30 participants 31 participants 61 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
  10.0%
5
  16.1%
8
  13.1%
White
26
  86.7%
24
  77.4%
50
  82.0%
More than one race
0
   0.0%
2
   6.5%
2
   3.3%
Unknown or Not Reported
1
   3.3%
0
   0.0%
1
   1.6%
[1]
Measure Description: Data reported for the adolescents in each dyad
[2]
Measure Analysis Population Description: Each row separately presents racial breakdown for parents and teens. Total number of parents and teens adds up to the total sample
Adolescent percent days abstinent over past 90 days (adjusted for days in a controlled environment)   [1] 
Mean (Standard Deviation)
Unit of measure:  Percent
Number Analyzed 30 participants 31 participants 61 participants
58.04  (40.43) 63.93  (40.49) 61.03  (40.49)
[1]
Measure Analysis Population Description: This analysis was only done with adolescent data. Parents did not report on days of substance use.
1.Primary Outcome
Title Change in Proportion of Days Used Outside of Controlled Environment
Hide Description Global Appraisal of Individual Needs - Quick Version (GAIN-Q3) is a well-validated substance use screening tool used to assess adolescent substance use in a range of settings. Substance consumption information is collected using a calendar format with temporal cues (e.g., holidays) to assist in recall of days when alcohol and other drugs were used. Possible number of days range from 0 to 90. Values are adjusted to reflect the proportion of days used outside of controlled environment, with final values ranging from 0 to 1.0; a higher number indicates a higher proportion of days used.
Time Frame Change from baseline to 24-week post-discharge
Hide Outcome Measure Data
Hide Analysis Population Description
This table reports mean values at 12-weeks and 24-weeks with listwise deletion. The pre-specified analytic plan uses mixed models with full maximum likelihood estimation (intent-to-treat) and data from all 30 PW and all 31 TAU adolescents.
Arm/Group Title Parenting Wisely+ Treatment as Usual
Hide Arm/Group Description:

Parenting Wisely+ consists of access to the Parenting Wisely computer program (www.parentingwisely.com), paired with engagement strategies: up to four in-person coaching sessions, daily text messages, and access to an online networking forum.

Parenting Wisely+: Parenting Wisely+ consists of access to the Parenting Wisely computer program, paired with engagement strategies: up to four parent coaching sessions, daily text messages, and access to an online networking forum

Treatment as Usual: The active comparator is residential treatment as usual

The active comparator is defined as residential treatment services as usual.

Treatment as Usual: The active comparator is residential treatment as usual

Overall Number of Participants Analyzed 30 31
Mean (Standard Deviation)
Unit of Measure: proportion of days used
12 Weeks Post Discharge Number Analyzed 22 participants 25 participants
.27  (.36) .35  (.41)
24 Weeks Post Discharge Number Analyzed 20 participants 26 participants
.35  (.36) .32  (36)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Parenting Wisely+, Treatment as Usual
Comments Mixed models with zero-inflated distributions evaluated whether there was a Time*Condition interaction, using data from the baseline, 12-week, and 24-week assessments. Full maximum likelihood estimation was used. We tested the primary outcome (percent of days of use over the past 90 days, adjusted for time in a controlled environment) for overall number of days of use.
Type of Statistical Test Superiority
Comments In zero-inflated distributions, two outcomes can be specified: 1) probability of being an excess zero (falling outside expected negative binomial distribution), and 2) count value, if not an excess zero. Our focal effect of interest was Time*Condition in the count distribution, i.e. effect of condition over time on predicting the percent of days used greater than zero.
Statistical Test of Hypothesis P-Value .12
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.15
Confidence Interval (2-Sided) 95%
.97 to 1.36
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.57
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change in Global Appraisal of Individual Needs - Quick Version (GAIN-Q3) Substance-Related Problems Scale
Hide Description The GAIN-Q3 is a well-validated substance use screening tool used to assess adolescent substance use in a range of settings. The Substance-Related Problems Scale provides a count of substance-related problems experienced over the past 90 days. Possible values range from 0 to 11, with higher scores indicating a greater number of substance-related problems.
Time Frame Change in substance-related problems from baseline to the 24-week post-discharge assessment
Hide Outcome Measure Data
Hide Analysis Population Description
The pre-specified analysis plan uses mixed models with all adolescents randomized to condition.
Arm/Group Title Parenting Wisely+ Treatment as Usual
Hide Arm/Group Description:

Parenting Wisely+ consists of access to the Parenting Wisely computer program (www.parentingwisely.com), paired with engagement strategies: up to four in-person coaching sessions, daily text messages, and access to an online networking forum.

Parenting Wisely+: Parenting Wisely+ consists of access to the Parenting Wisely computer program, paired with engagement strategies: up to four parent coaching sessions, daily text messages, and access to an online networking forum

Treatment as Usual: The active comparator is residential treatment as usual

The active comparator is defined as residential treatment services as usual.

Treatment as Usual: The active comparator is residential treatment as usual

Overall Number of Participants Analyzed 30 31
Mean (Standard Deviation)
Unit of Measure: score on a scale
12 Weeks Post Discharge Number Analyzed 22 participants 25 participants
1.86  (1.89) 1.36  (1.52)
24 Weeks Post Discharge Number Analyzed 20 participants 26 participants
1.40  (1.70) 1.85  (1.83)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Parenting Wisely+, Treatment as Usual
Comments Mixed models using a linear distribution evaluated whether change in substance-related problems differed by condition. The focal effect was a Time*Condition interaction, using data from the baseline, 12-week, and 24-week assessments. Full maximum likelihood estimation was used.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .19
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value -.10
Confidence Interval (2-Sided) 95%
-.34 to .07
Parameter Dispersion
Type: Standard Error of the Mean
Value: .34
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Count of Adolescents Testing Negative on Urine Screens
Hide Description 8 panel urine drug screens testing for marijuana, ecstasy/molly, cocaine, amphetamines, methamphetamines, opiates, oxycodone, and benzodiazepines. Urine screen results will be coded as positive or negative for any substance, and a count of adolescents obtaining a negative urine screen in each condition will be obtained.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Adolescents who completed a urine screen at 12 weeks.
Arm/Group Title Parenting Wisely+ Treatment as Usual
Hide Arm/Group Description:

Parenting Wisely+ consists of access to the Parenting Wisely computer program (www.parentingwisely.com), paired with engagement strategies: up to four in-person coaching sessions, daily text messages, and access to an online networking forum.

Parenting Wisely+: Parenting Wisely+ consists of access to the Parenting Wisely computer program, paired with engagement strategies: up to four parent coaching sessions, daily text messages, and access to an online networking forum

Treatment as Usual: The active comparator is residential treatment as usual

The active comparator is defined as residential treatment services as usual.

Treatment as Usual: The active comparator is residential treatment as usual

Overall Number of Participants Analyzed 15 20
Measure Type: Count of Participants
Unit of Measure: Participants
5
  33.3%
7
  35.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Parenting Wisely+, Treatment as Usual
Comments Comparison of the count of positive urine screens by condition at 12 weeks
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .92
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Chi-square value
Estimated Value .01
Estimation Comments [Not Specified]
Time Frame Approximately 25-30 weeks (baseline assessment done upon admission to residential treatment; follow-ups done over 24 weeks post-discharge. Duration of treatment varied from 6 days to 45 days across the sample)
Adverse Event Reporting Description

Used standard National Institutes of Health definition of study-related adverse and serious adverse events.

Adverse events and serious adverse events were assessed systematically as part of the comprehensive follow-up assessments. Adverse events included instances of juvenile justice involvement (i.e., arrest or incarceration of the adolescent) that were not directly associated with the research, but were temporally associated with the research.

 
Arm/Group Title Parenting Wisely+ Treatment as Usual
Hide Arm/Group Description

Parenting Wisely+ consists of access to the Parenting Wisely computer program (www.parentingwisely.com), paired with engagement strategies: up to four in-person coaching sessions, daily text messages, and access to an online networking forum.

Parenting Wisely+: Parenting Wisely+ consists of access to the Parenting Wisely computer program, paired with engagement strategies: up to four parent coaching sessions, daily text messages, and access to an online networking forum

Treatment as Usual: The active comparator is residential treatment as usual

The active comparator is defined as residential treatment services as usual.

Treatment as Usual: The active comparator is residential treatment as usual

All-Cause Mortality
Parenting Wisely+ Treatment as Usual
Affected / at Risk (%) Affected / at Risk (%)
Total   0/60 (0.00%)      0/62 (0.00%)    
Hide Serious Adverse Events
Parenting Wisely+ Treatment as Usual
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/60 (0.00%)      0/62 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Parenting Wisely+ Treatment as Usual
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/60 (5.00%)      3/62 (4.84%)    
Investigations     
Juvenile justice involvement   3/60 (5.00%)  3 3/62 (4.84%)  3
Indicates events were collected by systematic assessment
Small pilot trial designed to inform the design of a fully powered trial. The pre-specified analytical plan used mixed models: hence, the outcome values reported here (means, standard deviations) will not align with the primary outcome analysis.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Sara Becker, Ph.D, Principal Investigator
Organization: Brown University School of Public Health
Phone: 4018636604
EMail: sara_becker@brown.edu
Layout table for additonal information
Responsible Party: Brown University
ClinicalTrials.gov Identifier: NCT03592186    
Other Study ID Numbers: 1802001981
R34DA039289 ( U.S. NIH Grant/Contract )
First Submitted: April 25, 2018
First Posted: July 19, 2018
Results First Submitted: July 9, 2020
Results First Posted: December 11, 2020
Last Update Posted: January 21, 2022