Trial Outcomes & Findings for Adolescents With Substance Use Disorders Transitioníng From Residential Treatment to the Community (NCT NCT03592186)

Last Updated: 2022-01-21

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

122 participants

Primary outcome timeframe

Change from baseline to 24-week post-discharge

Results posted on

2022-01-21

Participant Flow

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).

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.

Unit of analysis: Dyads (adolescent + parent)

Participant milestones

Participant milestones
Measure	Parenting Wisely+ 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	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 Study STARTED	60 30	62 31
Overall Study 6-week Follow-up	49 25	56 29
Overall Study 12-week Follow-up	47 27	51 27
Overall Study COMPLETED	43 24	51 27
Overall Study NOT COMPLETED	17 6	11 4

Reasons for withdrawal

Reasons for withdrawal
Measure	Parenting Wisely+ 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	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 Study Withdrawal by Subject	1	0
Overall Study Lost to Follow-up	16	11

Baseline Characteristics

Row population differs from Overall, because age was separately calculated for parents and teens.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Change from baseline to 24-week post-discharge

Population: 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.

Outcome measures

Outcome measures
Measure	Treatment as Usual n=31 Participants The active comparator is defined as residential treatment services as usual. Treatment as Usual: The active comparator is residential treatment as usual	Parenting Wisely+ n=30 Participants 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
Change in Proportion of Days Used Outside of Controlled Environment 24 Weeks Post Discharge	.32 proportion of days used Standard Deviation 36	.35 proportion of days used Standard Deviation .36
Change in Proportion of Days Used Outside of Controlled Environment 12 Weeks Post Discharge	.35 proportion of days used Standard Deviation .41	.27 proportion of days used Standard Deviation .36

SECONDARY outcome

Timeframe: Change in substance-related problems from baseline to the 24-week post-discharge assessment

Population: The pre-specified analysis plan uses mixed models with all adolescents randomized to condition.

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.

Outcome measures

Outcome measures
Measure	Treatment as Usual n=31 Participants The active comparator is defined as residential treatment services as usual. Treatment as Usual: The active comparator is residential treatment as usual	Parenting Wisely+ n=30 Participants 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
Change in Global Appraisal of Individual Needs - Quick Version (GAIN-Q3) Substance-Related Problems Scale 12 Weeks Post Discharge	1.36 score on a scale Standard Deviation 1.52	1.86 score on a scale Standard Deviation 1.89
Change in Global Appraisal of Individual Needs - Quick Version (GAIN-Q3) Substance-Related Problems Scale 24 Weeks Post Discharge	1.85 score on a scale Standard Deviation 1.83	1.40 score on a scale Standard Deviation 1.70

SECONDARY outcome

Timeframe: 12 weeks

Population: Adolescents who completed a urine screen at 12 weeks.

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.

Outcome measures

Outcome measures
Measure	Treatment as Usual n=20 Participants The active comparator is defined as residential treatment services as usual. Treatment as Usual: The active comparator is residential treatment as usual	Parenting Wisely+ n=15 Participants 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
Count of Adolescents Testing Negative on Urine Screens	7 Participants	5 Participants

Adverse Events

Parenting Wisely+

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Treatment as Usual

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Parenting Wisely+ n=60 participants at risk 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	Treatment as Usual n=62 participants at risk The active comparator is defined as residential treatment services as usual. Treatment as Usual: The active comparator is residential treatment as usual
Investigations Juvenile justice involvement	5.0% 3/60 • Number of events 3 • 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) 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.	4.8% 3/62 • Number of events 3 • 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) 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.

Additional Information

Sara Becker, Ph.D, Principal Investigator

Brown University School of Public Health

Phone: 4018636604

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Parenting Wisely+ n=60 Participants 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	Treatment as Usual n=62 Participants The active comparator is defined as residential treatment services as usual. Treatment as Usual: The active comparator is residential treatment as usual	Total n=122 Participants Total of all reporting groups
Age, Customized Parent age	43.93 years STANDARD_DEVIATION 6.52 • n=30 Participants • Row population differs from Overall, because age was separately calculated for parents and teens.	41.23 years STANDARD_DEVIATION 6.75 • n=31 Participants • Row population differs from Overall, because age was separately calculated for parents and teens.	42.56 years STANDARD_DEVIATION 6.72 • n=61 Participants • Row population differs from Overall, because age was separately calculated for parents and teens.
Age, Customized Teen age	15.80 years STANDARD_DEVIATION 0.93 • n=30 Participants • Row population differs from Overall, because age was separately calculated for parents and teens.	15.61 years STANDARD_DEVIATION 1.12 • n=31 Participants • Row population differs from Overall, because age was separately calculated for parents and teens.	15.7 years STANDARD_DEVIATION 1.02 • n=61 Participants • Row population differs from Overall, because age was separately calculated for parents and teens.
Sex/Gender, Customized Teen Female	15 Participants n=60 Participants	17 Participants n=62 Participants	32 Participants n=122 Participants
Sex/Gender, Customized Teen Male	13 Participants n=60 Participants	14 Participants n=62 Participants	27 Participants n=122 Participants
Sex/Gender, Customized Teen Other / Prefer not to answer	2 Participants n=60 Participants	0 Participants n=62 Participants	2 Participants n=122 Participants
Sex/Gender, Customized Parent Female	26 Participants n=60 Participants	24 Participants n=62 Participants	50 Participants n=122 Participants
Sex/Gender, Customized Parent Male	4 Participants n=60 Participants	7 Participants n=62 Participants	11 Participants n=122 Participants
Sex/Gender, Customized Parent Other / Prefer not to answer	0 Participants n=60 Participants	0 Participants n=62 Participants	0 Participants n=122 Participants
Ethnicity (NIH/OMB) Teen Ethnicity · Hispanic or Latino	10 Participants n=30 Participants • Each row separately reports on ethnicity for parents and teens.	6 Participants n=31 Participants • Each row separately reports on ethnicity for parents and teens.	16 Participants n=61 Participants • Each row separately reports on ethnicity for parents and teens.
Ethnicity (NIH/OMB) Teen Ethnicity · Not Hispanic or Latino	20 Participants n=30 Participants • Each row separately reports on ethnicity for parents and teens.	25 Participants n=31 Participants • Each row separately reports on ethnicity for parents and teens.	45 Participants n=61 Participants • Each row separately reports on ethnicity for parents and teens.
Ethnicity (NIH/OMB) Teen Ethnicity · Unknown or Not Reported	0 Participants n=30 Participants • Each row separately reports on ethnicity for parents and teens.	0 Participants n=31 Participants • Each row separately reports on ethnicity for parents and teens.	0 Participants n=61 Participants • Each row separately reports on ethnicity for parents and teens.
Ethnicity (NIH/OMB) Parent Ethnicity · Hispanic or Latino	8 Participants n=30 Participants • Each row separately reports on ethnicity for parents and teens.	2 Participants n=31 Participants • Each row separately reports on ethnicity for parents and teens.	10 Participants n=61 Participants • Each row separately reports on ethnicity for parents and teens.
Ethnicity (NIH/OMB) Parent Ethnicity · Not Hispanic or Latino	22 Participants n=30 Participants • Each row separately reports on ethnicity for parents and teens.	29 Participants n=31 Participants • Each row separately reports on ethnicity for parents and teens.	51 Participants n=61 Participants • Each row separately reports on ethnicity for parents and teens.
Ethnicity (NIH/OMB) Parent Ethnicity · Unknown or Not Reported	0 Participants n=30 Participants • Each row separately reports on ethnicity for parents and teens.	0 Participants n=31 Participants • Each row separately reports on ethnicity for parents and teens.	0 Participants n=61 Participants • Each row separately reports on ethnicity for parents and teens.
Race (NIH/OMB) Teen Race · American Indian or Alaska Native	0 Participants n=30 Participants • Each row separately presents racial breakdown for parents and teens. Total number of parents and teens adds up to the total sample	0 Participants n=31 Participants • Each row separately presents racial breakdown for parents and teens. Total number of parents and teens adds up to the total sample	0 Participants n=61 Participants • Each row separately presents racial breakdown for parents and teens. Total number of parents and teens adds up to the total sample
Race (NIH/OMB) Teen Race · Asian	0 Participants n=30 Participants • Each row separately presents racial breakdown for parents and teens. Total number of parents and teens adds up to the total sample	1 Participants n=31 Participants • Each row separately presents racial breakdown for parents and teens. Total number of parents and teens adds up to the total sample	1 Participants n=61 Participants • Each row separately presents racial breakdown for parents and teens. Total number of parents and teens adds up to the total sample
Race (NIH/OMB) Teen Race · Native Hawaiian or Other Pacific Islander	0 Participants n=30 Participants • Each row separately presents racial breakdown for parents and teens. Total number of parents and teens adds up to the total sample	0 Participants n=31 Participants • Each row separately presents racial breakdown for parents and teens. Total number of parents and teens adds up to the total sample	0 Participants n=61 Participants • Each row separately presents racial breakdown for parents and teens. Total number of parents and teens adds up to the total sample
Race (NIH/OMB) Teen Race · Black or African American	3 Participants n=30 Participants • Each row separately presents racial breakdown for parents and teens. Total number of parents and teens adds up to the total sample	4 Participants n=31 Participants • Each row separately presents racial breakdown for parents and teens. Total number of parents and teens adds up to the total sample	7 Participants n=61 Participants • Each row separately presents racial breakdown for parents and teens. Total number of parents and teens adds up to the total sample
Race (NIH/OMB) Teen Race · White	21 Participants n=30 Participants • Each row separately presents racial breakdown for parents and teens. Total number of parents and teens adds up to the total sample	14 Participants n=31 Participants • Each row separately presents racial breakdown for parents and teens. Total number of parents and teens adds up to the total sample	35 Participants n=61 Participants • Each row separately presents racial breakdown for parents and teens. Total number of parents and teens adds up to the total sample
Race (NIH/OMB) Teen Race · More than one race	1 Participants n=30 Participants • Each row separately presents racial breakdown for parents and teens. Total number of parents and teens adds up to the total sample	8 Participants n=31 Participants • Each row separately presents racial breakdown for parents and teens. Total number of parents and teens adds up to the total sample	9 Participants n=61 Participants • Each row separately presents racial breakdown for parents and teens. Total number of parents and teens adds up to the total sample
Race (NIH/OMB) Teen Race · Unknown or Not Reported	5 Participants n=30 Participants • Each row separately presents racial breakdown for parents and teens. Total number of parents and teens adds up to the total sample	4 Participants n=31 Participants • Each row separately presents racial breakdown for parents and teens. Total number of parents and teens adds up to the total sample	9 Participants n=61 Participants • Each row separately presents racial breakdown for parents and teens. Total number of parents and teens adds up to the total sample
Race (NIH/OMB) Parent Race · American Indian or Alaska Native	0 Participants n=30 Participants • Each row separately presents racial breakdown for parents and teens. Total number of parents and teens adds up to the total sample	0 Participants n=31 Participants • Each row separately presents racial breakdown for parents and teens. Total number of parents and teens adds up to the total sample	0 Participants n=61 Participants • Each row separately presents racial breakdown for parents and teens. Total number of parents and teens adds up to the total sample
Race (NIH/OMB) Parent Race · Asian	0 Participants n=30 Participants • Each row separately presents racial breakdown for parents and teens. Total number of parents and teens adds up to the total sample	0 Participants n=31 Participants • Each row separately presents racial breakdown for parents and teens. Total number of parents and teens adds up to the total sample	0 Participants n=61 Participants • Each row separately presents racial breakdown for parents and teens. Total number of parents and teens adds up to the total sample
Race (NIH/OMB) Parent Race · Native Hawaiian or Other Pacific Islander	0 Participants n=30 Participants • Each row separately presents racial breakdown for parents and teens. Total number of parents and teens adds up to the total sample	0 Participants n=31 Participants • Each row separately presents racial breakdown for parents and teens. Total number of parents and teens adds up to the total sample	0 Participants n=61 Participants • Each row separately presents racial breakdown for parents and teens. Total number of parents and teens adds up to the total sample
Race (NIH/OMB) Parent Race · Black or African American	3 Participants n=30 Participants • Each row separately presents racial breakdown for parents and teens. Total number of parents and teens adds up to the total sample	5 Participants n=31 Participants • Each row separately presents racial breakdown for parents and teens. Total number of parents and teens adds up to the total sample	8 Participants n=61 Participants • Each row separately presents racial breakdown for parents and teens. Total number of parents and teens adds up to the total sample
Race (NIH/OMB) Parent Race · White	26 Participants n=30 Participants • Each row separately presents racial breakdown for parents and teens. Total number of parents and teens adds up to the total sample	24 Participants n=31 Participants • Each row separately presents racial breakdown for parents and teens. Total number of parents and teens adds up to the total sample	50 Participants n=61 Participants • Each row separately presents racial breakdown for parents and teens. Total number of parents and teens adds up to the total sample
Race (NIH/OMB) Parent Race · More than one race	0 Participants n=30 Participants • Each row separately presents racial breakdown for parents and teens. Total number of parents and teens adds up to the total sample	2 Participants n=31 Participants • Each row separately presents racial breakdown for parents and teens. Total number of parents and teens adds up to the total sample	2 Participants n=61 Participants • Each row separately presents racial breakdown for parents and teens. Total number of parents and teens adds up to the total sample
Race (NIH/OMB) Parent Race · Unknown or Not Reported	1 Participants n=30 Participants • Each row separately presents racial breakdown for parents and teens. Total number of parents and teens adds up to the total sample	0 Participants n=31 Participants • Each row separately presents racial breakdown for parents and teens. Total number of parents and teens adds up to the total sample	1 Participants n=61 Participants • 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)	58.04 percent STANDARD_DEVIATION 40.43 • n=30 Participants • This analysis was only done with adolescent data. Parents did not report on days of substance use.	63.93 percent STANDARD_DEVIATION 40.49 • n=31 Participants • This analysis was only done with adolescent data. Parents did not report on days of substance use.	61.03 percent STANDARD_DEVIATION 40.49 • n=61 Participants • This analysis was only done with adolescent data. Parents did not report on days of substance use.