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

• 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: Brown University
• 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

Participant Flow

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
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).

Baseline Characteristics

Arm/Group Title		Parenting Wisely+	Treatment as Usual	Total
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
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.

Outcome Measures

1. Primary Outcome

Title	Change in Proportion of Days Used Outside of Controlled Environment
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

Outcome Measure Data

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
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)

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
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

Outcome Measure Data

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
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)

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
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

Outcome Measure Data

Analysis Population Description

Adolescents who completed a urine screen at 12 weeks.

Arm/Group Title	Parenting Wisely+	Treatment as Usual
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%

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]

Adverse Events

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
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%)
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%)
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

Limitations and Caveats

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.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Sara Becker, Ph.D, Principal Investigator
• Organization: Brown University School of Public Health
• Phone: 4018636604
• EMail: sara_becker@brown.edu

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Becker SJ, Helseth SA, Janssen T, Kelly LM, Escobar KI, Souza T, Wright T, Spirito A. Parent SMART (Substance Misuse in Adolescents in Residential Treatment): Pilot randomized trial of a technology-assisted parenting intervention. J Subst Abuse Treat. 2021 Aug;127:108457. doi: 10.1016/j.jsat.2021.108457. Epub 2021 Apr 30.

• 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