- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03592186
Adolescents With Substance Use Disorders Transitioníng From Residential Treatment to the Community
Adolescents With Substance Use Disorders Transitioning From Residential Treatment to the Community: Improving Outcomes Via a Computer Assisted Parenting Program
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This small pilot trial evaluates a low cost, low intensity model for delivering parenting skills to parents preparing for their adolescent's discharge from residential substance use (SU) treatment. Specifically, this project adapts a computerized parenting intervention (Parenting Wisely; PW) that has preliminary evidence of efficacy in improving parenting skills and reducing youth behavior problems for a new population (parents of adolescents with SU) and new setting (residential treatment).
Participants: A minimum of 60 parent-adolescent dyads will be recruited from residential treatment. To guide design decisions for a larger trial, we made the decision after trial registration to recruit from one short-term residential treatment program and one long-term residential treatment program. Parental inclusion criteria: (1) be parent or legal guardian of an adolescent, aged 12-17 years; (2) had adolescent admitted to residential treatment due to problems related to substance use; (3) will be the primary guardian living with the adolescent immediately post-discharge; (4) willing to receive a parenting intervention; (5) fluent in English or Spanish; and (6) willing to provide written consent. Adolescents qualify if their parents meet these criteria as well as: (1) are fluent in English or Spanish and (2) willing to provide written assent. The only exclusion criteria are conditions that might preclude the adolescent's or parent's participation in a 2-3 hour interview (e.g., mania, psychosis, and cognitive impairment).
Study enrollment and randomization: Parents of all newly admitted adolescents will be screened for substance use and those screening positive, will receive a Consent to Contact (CoC) form. Parents that sign a CoC form will be contacted by research staff and invited in for a consent session.
Parents will provide written informed consent and adolescents will provide written assent in separate private rooms at the residential center. Parents and adolescents may choose to conduct the informed consent process and all study procedures in English or Spanish.
Parents will be given the choice whether to return for the baseline assessment or complete it following informed consent. Randomization will occur within 24 hours after the baseline assessment. Parent-adolescent dyads will be randomized by a blind research staff member to either treatment as usual or PW+ using urn randomization balanced on sex, frequency of substance use, and race/ethnicity. The evaluator will give parents condition assignments in sealed envelopes. If the parent is assigned to PW+, the evaluator will schedule the first coaching session. Coaching sessions were offered via multiple modalities to increase engagement: in-person, phone, or video conference.
Therapist training, fidelity, and competence: Treatment will be delivered by Bachelor's or Master's-level parent coaches, at least one of whom is bilingual in English and Spanish. The study principal investigator (PI) will train the coaches. Coach therapeutic competence will be rated with six items that comprise the "General Therapeutic Skills" section of the Cognitive Therapy Rating Scale (CTRS). A score >24 is the criterion for competence. Study specific adherence checklists have been developed. The coaches will be required to earn a satisfactory consensus CTRS score of >24 and satisfactory adherence ratings (> 80% of elements) on two consecutive role plays to be assigned participants. All sessions will be rated for adherence and competence. A minimum of 25% of tapes will be double rated. The PI will meet weekly with the coaches for supervision focused on how to deliver PW+ with adherence and competence.
Treatment as Usual (TAU): TAU is the standard treatment offered to all patients at the residential center. Adolescents receive about 25 hours of treatment per week with average length of stay 6-10 days at the short-term residential center and 30-45 days at the long-term residential center. Parents are typically offered 2 family therapy sessions. Adolescents receive 4-5 hours of individual and group therapy sessions per day, consisting of psychoeducation and general skills building. Medication management is offered as needed. Prior to discharge, parents also receive standard discharge planning, which consists of either a referral to a new outpatient therapy provider or return to a prior outpatient therapy provider.
Adapted PW program: In addition to TAU , parents in the PW+ will receive: Parenting Wisely online modules, in-person coaching sessions, personalized text messages, and an expert-moderated online parent board.
Parenting Wisely online modules: Parenting Wisely (PW/Ser Padres Con Sabiduría) is a self-administered, interactive, multimedia online program. PW contains video vignettes of ten common family problems (e.g., adolescent substance use, curfews, household chores, monitoring of friends, sibling conflict, improving in school, getting up on time, sharing technology, etc.). For each problem, parents progress through three activities: viewing of a video clip of a family struggling with the problem; selection of one of three possible solutions to the problem; and receipt of feedback about the solution selected. Feedback is presented via a video enactment of the selected solution and an explanation of the solution's pros and cons. Goals of the feedback are to explain why ineffective solutions lead to problems and discuss how effective parenting solutions can prevent and resolve common family issues. Parents receive a parent workbook outlining all 10 vignettes, along with the potential problems and solutions. Parents create a unique login upon enrollment and can complete sessions at their own pace. PW typically takes 3-5 hours to complete.
Individual coaching sessions: Sessions individually tailor PW skills to each parent's presenting concerns, corresponding with four PW vignettes: substance use, limit setting, parental monitoring, and parental communication. The initial session is 60-75 min and consists of three sections: (1) rationale for parenting skills, (2) review of PW substance use module (in session), and (3) practice applying the skill to a current problem. Subsequent sessions follow the same outline and last 45-60 min, with active use of the PW program comprising about half the session. If parents introduce problems/complaints about their adolescent, the coach provides validation and discusses how to apply a pertinent PW skill.
Text-based messaging: Following discharge, parents will receive text messages daily for up to 24 weeks to: (a) reinforce PW skills, (b) motivate continued PW usage, and (c) encourage participation in the online parent message board.
Online parent board: Parents will be given access to a secure, expert-moderated website containing two networking forums (Ask an Expert, Connect with Parents). The website is accessible via a user-friendly smartphone application or "app" (similar to app versions of websites for sites such as Pinterest and Facebook). Parents will be able to submit questions anonymously using the same unique login as for the PW program. Questions posted on the message board will be answered by the research team within 48 hours. Answers to questions posted on the message board will direct parents to a specific PW module(s) most relevant to their parenting question. Participation on the message board will be encouraged for up to 24 weeks post-discharge.
Exit interviews: At each follow-up, parents complete exit interviews containing questions about each aspect of the intervention, including the in-person sessions (e.g., number, content, format), text messages (e.g., content, frequency, format), and online message board (e.g., ease of access, content, format). Parents will also complete the 16-item Consumer Satisfaction Questionnaire (CSQ), which rates their satisfaction with treatment delivery, their adolescent's treatment progress, and their ability to manage their adolescent's problems.
Assessments: Follow-up assessments at 6, 12, and 24 weeks post-discharge will be conducted by an independent evaluator blind to condition. Assessments will be 1.5-2 hours. The primary and secondary outcomes are detailed in the Outcome section. Multiple steps will be taken to prevent attrition. First, multiple sources of contact information will be recorded for parents and adolescents. Follow-up reminders will be made via phone, text, and/or mail. The research team will meet weekly to review no-shows and outreach attempts, and discuss plans to connect with missing participants.
Data analysis plan: All 60 parents will be included in statistical analyses consistent with an intent-to-treat model. Prior to the main analyses, descriptive statistics will be run on key variables to examine distributional properties, identify outliers, and transform variables as needed. The treatment conditions will be compared on baseline demographic and clinical variables using basic two-group independent sample t-tests. Using a p < .05 criterion, significant pre-existing baseline differences between conditions will be controlled in subsequent analyses.
Attrition analyses will compare follow-up completers and non-completers on baseline clinical and demographic variables to determine if they differ systematically. If no systematic differences are found between completers and non-completers, then missing data will be estimated using multiple imputation methods.
Outcomes will be analyzed at 6, 12, and 24 weeks post baseline. Analyses will compare trajectories of use over the post-discharge period, controlling for baseline status as a covariate. For each dependent variable, separate repeated measures Analysis of Covariance will test the influence of condition, controlling for the following covariates: baseline status on the dependent variable, baseline differences between groups, and any mental health or substance use treatment received over the follow-up period. The effect of PW dosage on each dependent variable will be calculated and partial eta squared (η2) will be used to estimate the proportion of variance caused by PW. The primary analytical goal will be to provide measures of association and 95% confidence intervals to reveal the effect size of PW on each dependent variable. The goal of these analyses is to find promising trends to pursue in a larger fully powered trial.
The Primary Aim of the NIH-funded application that funded this study was to establish the feasibility and acceptability of the experimental intervention (Primary Aim 1: To examine the feasibility and acceptability of an adapted PW intervention that includes moderate engagement strategies for parents of adolescents with substance use disorders preparing for discharge from residential). The Secondary Aim of the NIH-funded study was to examine the preliminary effectiveness of the experimental intervention on adolescent substance use, adolescent high-risk behavior, and parenting behavior (Secondary Aims 2-4: To test the effectiveness of the adapted PW intervention + treatment as usual (PW+TAU) versus TAU only on: substance use outcomes, related high-risk behaviors, and parenting skills (the putative mediators of change).) Approximately midway through this study, with the support of the Program Officer, a second residential facility was added. This was to ensure that the study met its pre-specified recruitment targets, and also enabled us to test study procedures at one short-term residential facility and one-long term residential facility, to help inform the design of a future fully powered trial.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Illinois
-
Rockford, Illinois, United States, 61107
- Rosecrance Health Network
-
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Rhode Island
-
Cranston, Rhode Island, United States, 02920
- Caritas ARTS Program
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria for Adolescents:
- age 12 years -17 years inclusive
- admitted to residential treatment due to problems related to substance use
- ability to complete study assessments in English or Spanish
- ability to understand and willingness to provide written assent
Exclusion Criteria for Adolescents:
-- Conditions that preclude participation in a 2-3 hour interview (e.g., mania, psychosis, intoxication, cognitive impairment)
Inclusion Criteria for Parents:
- legal guardian of adolescent meeting the adolescent inclusion criteria
- primary custodial guardian of the adolescent after discharge from residential
- access to the internet in the home or workplace to view intervention content, as well as access to a phone that can receive text messages
- ability to complete study sessions and assessments in English or Spanish (and must complete the first baseline assessment prior to teen's discharge from residential)
- ability to understand and willingness to provide written consent
Exclusion Criteria for Parents:
-- Conditions that preclude participation in a 1-2 hour interview (e.g., mania, psychosis, intoxication, cognitive impairment)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
Treatment as Usual
Parenting Wisely+ experimental intervention
Other Names:
|
Active Comparator: Treatment as Usual
The active comparator is defined as residential treatment services as usual. At short-term facility, average length of stay was 6-10 days. At long-term facility, average length of stay was 30-45 days. |
Treatment as Usual
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Proportion of Days Used Outside of Controlled Environment
Time Frame: Change from baseline to 24-week post-discharge
|
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.
|
Change from baseline to 24-week post-discharge
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Global Appraisal of Individual Needs - Quick Version (GAIN-Q3) Substance-Related Problems Scale
Time Frame: Change in substance-related problems from baseline to the 24-week post-discharge assessment
|
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.
|
Change in substance-related problems from baseline to the 24-week post-discharge assessment
|
Count of Adolescents Testing Negative on Urine Screens
Time Frame: 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.
|
12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sara J Becker, PhD, Brown University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1802001981
- R34DA039289 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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