Parent SMART (Substance Misuse in Adolescents in Residential Treatment): Protocol of a Randomized Effectiveness Trial of a Technology-Assisted Parenting Intervention

Background Adolescents in residential substance use treatment are at extremely high risk for relapse following discharge to the community. Parenting practices, including parental monitoring and parent-adolescent communication, have been established as key predictors of adolescent substance use outcomes and relapse. However, traditional office-based therapy may not be feasible for parents who face structural and systemic barriers. There is a clear need for effective, accessible, and scalable interventions for parents of adolescents receiving residential substance use treatment. In a prior pilot randomized controlled trial, we tested Parent SMART (Substance Misuse among Adolescents in Residential Treatment)—a technology-assisted parenting intervention informed by extensive formative research—as an adjunct to residential treatment as usual (TAU). Parent SMART demonstrated high feasibility and acceptability, as well as evidence of effectiveness in improving parental monitoring and communication. Objective This protocol paper describes a fully-powered randomized controlled pragmatic effectiveness trial of Parent SMART as an adjunct to residential TAU. We hypothesize that families who receive Parent SMART will demonstrate greater improvements in parenting skills, reductions in adolescent substance use, and reductions in adolescent problem behaviors relative to families that receive residential TAU. We will test the exploratory hypothesis that reductions in adolescent substance use will be partially mediated by improvements in parenting skills. Methods Adolescent-parent dyads (n = 220 dyads; 440 total) will be randomized to either residential TAU only or Parent SMART+TAU. Parents randomized to Parent SMART will receive access to a networking forum, an off-the-shelf computer program called Parenting Wisely, and up to four telehealth coaching calls. Multimethod follow-up assessments consisting of self-reported parent and adolescent measures, a parent-adolescent in vivo interaction task, and 8-panel urine screens will be conducted 6, 12, and 24 weeks postdischarge from residential care. Measures will assess parenting skills, adolescent substance use, and adolescent problem behaviors. Analyses will be conducted using latent change score structural equation modeling. Results The trial was funded in August 2021; ethics approval was obtained in August 2020, prior to funding. Due to concerns with the administrative interface in the pilot trial, the Parent SMART networking forum is currently being rebuilt by a different vendor. The programming is scheduled to be completed by December 2021, with recruitment beginning in February 2022. Conclusions The proposed research has the potential to advance the field by serving a high-need, underserved population during a vital treatment juncture; targeting parenting practices (putative mediators) that have been shown to predict adolescent substance use outcomes; addressing barriers to accessing continuing care; and testing a highly scalable intervention model. Trial Registration ClinicalTrials.gov NCT05169385; https://clinicaltrials.gov/ct2/show/NCT05169385 International Registered Report Identifier (IRRID) PRR1-10.2196/35934

IPTA BECKER, S PUBLIC HEALTH RELEVANCE: Adolescents in residential substance use treatment have high risk of relapse after discharge, but it is extremely difficult to engage these adolescents and their parents in continuing care. This study aims to improve the outcomes of adolescents following discharge from residential substance use treatment by offering their parents a novel technology-assisted intervention. Technology-assisted interventions have the potential for marked public health impact by extending the reach, duration, and scalability of evidence-based care.

CRITIQUE 1
Significance: 3 Investigator(s): 1 Innovation: 3 Approach: 3 Environment: 1 Overall Impact: Parents play a key role in adolescent relapse prevention, but they have been difficult to engage in treatment. This R01 application seeks to test a packaged parenting technology assisted intervention to prevent relapse among adolescents in two short-term residential programs with 220 parent/adolescent dyads who will be randomly assigned to the intervention or usual care. The intervention package includes an off-the-shelf parenting app, telehealth sessions (up to 4), and a networking app through which parents can connect with clinicians or other parents. Score driving factors were the potential of the intervention to engage parents with minimal burden to staff; the rigor of the pilot and formative work, in which virtually all aspects of the study have been piloted; and the responsiveness to feedback from the pilot (e.g., targeting short-term residential programs based on better effectiveness relative to long-term programs; the timing of intervention delivery). Also important were their strategies in place to recruit and retain underserved ethnic minority families. Concerns pertained to whether components of the intervention would be able to be scaled up, in particular, the research team is responsible for moderating the networking app, which causes concerns about external validity. Also, clinic staff mentioned that they typically do not provide parent only sessions while the adolescent is in care. It is important to consider whether facilities will be able to integrate this type of service into their regular practice (e.g., is it a billable expense). However, the evidence gained in this study may be what is needed to make this kind of shift in practice.

Strengths
• This study seeks to evaluate a scalable program to reduce substance use in a high-risk population, adolescents in residential substance use treatment (major) • Parents are key to preventing relapse for adolescents who require substance use treatment, yet they are difficult to engage in treatment (major) • A challenge is that 25% of downloaded apps are only used once, research is needed on continued engagement (moderate) • Existing interventions are time-intensive and create feasibility challenges for staff. Technology assisted interventions can serve as "clinician extenders" to enhance reach. They can reduce burden on frontline staff, limited financial resources, and supervisory support. They also provide some degree of anonymity for families, which is important in addressing sensitive topics (major) IPTA

BECKER, S
• This proposal builds on a previous NIDA-funded pilot and formative work with parents, adolescents, and treatment staff. The intervention, which includes an app and up to four telecoaching sessions, has evidence of feasibility, acceptability, parent satisfaction, and preliminary effectiveness (monitoring, communication, binge drinking, drug use, and school problems). This proposal is responsive to parent and staff feedback. For example, program starts when adolescents are in patient, a point when parents have more time to engage. Based on pilot work showing better effects in a short-term compared to longer term residential programs, the decision was made to focus on short-term (major)

Weaknesses
• Clinic staff noted it is rare to have parent only sessions while inpatient. It is not clear whether this could be integrated into the clinic practice (e.g., is it a billable expense) (moderate) • The research team will serve as moderators of the networking app, which compromises the external validity of the study. It is not clear if this could be scaled up by clinic staff with fidelity. (moderate) • There may be a gap between when parents initiative the program and when they actually have an opportunity to practice the skills with adolescents, however, given short-term residential programs are targeted, this gap is unlikely to be long (minor)

Strengths
• Investigators have conducted formative research guiding the development of the program and initial feasibility testing. (major) • Th PI has conducted reviews and meta-analyses that demonstrate the importance of including parents in interventions for adolescent substance use outperformed treatments that did not include parents (moderate) • The team has previously conducted studies comparing engagement in technology-based interventions, which provided justification for the inclusion of the telehealth sessions (major) • The team has a history of collaboration with the clinical sites (major) • The PI and Co-Is have a history of NIDA and NIMH funded clinical studies with high-risk adolescents. (major) • The team also has methodological expertise relevant to the study, including behavioral observation, longitudinal, and multi-method designs. (major)

Weaknesses
• None noted by reviewer.

Strengths
• This proposal is innovative in delivering a parenting intervention to prevent relapse for adolescents in residential treatment. The timing of the intervention (starting while adolescent is in care) is particularly innovative and likely to be impactful, given that it occurs at a time when parents may be most motivated to make changes, and able to engage in the intervention, given the reductions in their parenting responsibilities. (major) IPTA BECKER, S • Hybrid approach with off the shelf intervention paired with telehealth sessions and networking site where families can connect with a therapist of other parents (major) • Testing of mediation: this is not a new approach, but still underutilized (moderate)

Weaknesses
• None noted by reviewer.

Strengths
• Intervention has been piloted for feasibility, acceptability, and preliminary effectiveness; modifications were made based on feedback from parents and staff in a short-term (6-10 days) and long-term (30-45 days) residential programs. Adherence and competence as assessed, and thresholds were reached. (major) • Evidence-informed recruitment and retention procedures have been developed and piloted.
Multiple methods are in place to recruit and retain racial/ethnic minority youth. All staff will be bilingual/bicultural. All staff will be trained in culturally competent service delivery. The program materials are already available in Spanish (major) • Fidelity monitoring (adherence and competent delivery) procedures have been piloted. (major) • Multi-method assessment battery with validated measures: parent and adolescent self-report, interaction task, urine screen. (major) • Four data collection points, but only up until 24-weeks post-discharge (moderate) • Will use mediational modeling to test theoretical pathways from changes in parenting to changes in adolescent SU outcomes (moderate) • An answer bank has already been established for the "ask an expert" forum (moderate) • Proposed statistical analyses are appropriate and the study is sufficiently powered for the primary and secondary aims. (major)

Weaknesses
• It is not explained how thresholds for adherence and competence were achieved. It is not stated what will occur if counselors do not achieve the threshold on the roleplay. There also does not appear to be any active training (they will review the manual, workbook, and modules). (moderate) • Members of the investigative team are responsible for all aspects of the networking app. This causes concerns about external validity and sustainability. Specifically, if the program is deemed effective, it is unknown whether an agency could replicate these effects. It is also important to consider if there are staff available who could implement this piece and how they would be compensated for their time. (major) • A primary rationale for the study is on engagement, however, the protocol does not mention an assessment of engagement in the various components of the intervention. (moderate)

• Brown University's Center for Alcohol and Addictions Studies (CAAS) is an internationally renowned research center in substance use and addictions research
• CAAS is home to New England Addiction Technology Center (ATTC), led by PI Becker, a SAMHSA-funded regional center tasked with training substance use treatment providers across the 6-state New England region.
• Resources available for the project appear to be sufficient at the university and clinical sites.

Weaknesses
• None noted by reviewer.

Acceptable
• The PI has responsibility for developing and executing the DSMP. The DSMB will be chaired by a licensed clinical psychologist and NIH-funded researcher with experience in clinical trials. Other members will be drawn from the Center for Alcohol and Addictions Studies DSMB group and will include clinical and quantitative methods expertise. Meetings will be held twice a year and additionally as needed. The PI will draft a report prior to each meeting for review. AE and SAEs will be reported to the DSMB and IRB within 72 hours. SAEs will also be reported to NIDA. The DSMB will issue recommendations that the PI will be responsible for addressing. This information will be included in the annual report to NIDA, which the DSMB will review.

Inclusion Plans:
• Sex/Gender: Distribution justified scientifically Overall Impact: This R01 clinical trial application from Sara Becker proposes to build on her successful track record of research on adolescent and parent interventions to test Parent SMART, a technologyassisted enhancement of the evidence-based Parenting Wisely program, augmented for parents of teens who are completing residential treatment for substance use. The team is exceptional. The work stems directly from PI Becker's NIDA-funded R34, which yielded rich pilot data that guided the design of the proposed study in some very specific ways. The study is significant because adolescents in residential treatment have high rates of relapse, and there is good evidence that involving parents in interventions improves outcomes. The approach is generally rigorous and well thought-out, with design decisions informed by prior evidence from the literature and the team's research, with relevant alternatives thoroughly considered. The study design and execution plan includes various elements to enhance methodological rigor. Weaknesses are generally minor and do not detract from enthusiasm for this excellent application.

Strengths
• Adolescents in residential treatment are at high risk of relapse; strengthening parents' communication and monitoring capacity could improve outcomes in this vulnerable group.
• The application provides a thorough review of the prior research on the role of parent-youth communication and parental monitoring, the literature on the Parenting Wisely intervention, and the technology-assisted interventions. This review suggests that the proposed intervention builds upon a rigorous body of prior research, and the application articulates clearly how the intervention advances the current state of the science.

Weaknesses
• Adolescents undergoing short-term residential treatment for SUDs, with parents who are willing and able to engage in an extended technology-based intervention after treatment, are a fairly narrow (although certainly high risk) population. IPTA BECKER, S

Strengths
• Strong group of investigators led by PI Becker, an experienced PI and expert in adolescent and parenting interventions with a strong track record of scientific contributions.
• Co-I Spirito brings senior level expertise in adolescent clinical trials • Co-I Helseth is an early career scientist with an growing record of scientific contributions, working closely with the PI and Co-Is • Other Co-Is are likewise strong. The team has a history of successful collaboration.

Strengths
• Parent Smart includes innovative enhancements to an evidence-based intervention (Parenting Wisely), including in-person telehealth support, expert-moderated networking, a parenting forum, and push notifications. Taken together, these features are a novel and meaningful enhancement to an existing intervention.
• The intervention is novel in allowing parents to connect with experts, other parents, and automated content.

Strengths
• Preliminary studies are strong, relevant, and have informed the design in specific ways. It is clear that the investigators learned a great deal from the R34 experience and incorporated concrete refinements into the intervention based on parent feedback (e.g., timing of sessions). Likewise, the pilot findings informed fundamental design features of the proposed trial, such as focusing the targeted population on short-rather than long-term residential treatment. In general, the preliminary findings support moving towards a full-scale RCT.
• Well-considered casting of the study towards the effectiveness side of the efficacy-effectiveness spectrum, while retaining elements to strengthen internal validity.
• TAU as the comparator arm is reasonable and will inform practice.
• Proximal outcomes for parental monitoring and communication will be considered, as well as adolescent substance use outcomes and problem behaviors.
• Trial includes rigorous plans for fidelity monitoring.
• Residential treatment staff, assessors, and analyst will be blind to assignment (rigor).
• Measures are well-validated, and include adolescent drug testing biomarkers. IPTA

BECKER, S
• The intervention is available in English and Spanish, broadening reach.
• Recruitment projections are well-justified based on treatment admission flow and pilot data.
Recruitment and Retention plan is superb and adds confidence that high follow-up rates will be achieved.
• Proposed analysis methods are sophisticated.

Weaknesses
• The Parent SMART intervention relies on considerable ongoing staff support. The ultimate scalability of this intervention is an open question. Unclear what entity would pay for the infrastructure going forward, although this is a minor concern at this stage (largely a question for implementation science after effectiveness is established).
• Follow-up of only 24 weeks in duration will not capture longer-term effects (minor).
• Unclear if the testing panel will include fentanyl (minor).
• Rationale for including 18 year olds is unclear. It is possible that adults could be very different from minors with respect to relationships with parents and autonomy (minor).
• Although power appears adequate to detect small-moderate effect sizes on the intermediate outcomes of parenting dynamics and communication, with N=220 the study may be underpowered to detect effects on the ultimate target of adolescent relapse. (minor)

Strengths
• Brown University is an outstanding environment with ample resources and infrastructure to support the study. • Adolescent and parent dyads; adolescents ages 13-18, scientifically justified. Adolescents will be 65% white and 50% female. Parents are expected to be 80% female.

Not Applicable (No Vertebrate Animals)
Biohazards:

Not Applicable (No Biohazards)
Resource Sharing Plans:

Not Applicable (No Relevant Resources)
Budget and Period of Support:

CRITIQUE 3
Significance: 1 Investigator(s): 1 Innovation: 2 Approach: 3 Environment: 1 Overall Impact: This new R01 application by Dr. Sara Becker (PI) will enroll 220 adolescent/parent dyads in short-term residential substance use (SU) treatment. This two-group RCT is designed to evaluate the effectiveness of a technology-assisted parenting intervention called Parent SMART (Substance Misuse among Adolescents in Residential Treatment) + TAU versus TAU on parent outcomes: parental monitoring and communication and adolescent substance use outcomes: days of use and substance-related problems (primary outcomes) and adolescent problem behavior (secondary outcomes). They will also evaluate the extent to which change in parenting processes mediates change in adolescent substance outcomes. Parent SMART was built from a known computer program called Parenting Wisely (PW) which has shown effectiveness in improving parenting skills and youth behavior problems. PW was augmented in Parent SMART to include: a) access to an expert-moderated mobile networking forum with push notifications and SMS messages and b) up to 4 telehealth sessions to tailor delivery of the PW content. The sessions begin during the teen's residential treatment. Outcomes will be measured at 6-, 12-, and 24-weeks after discharge. This research area is significant and the rigor is IPTA BECKER, S high as Parent SMART has been tested in both short-and long-term residential facilities in a NIDAfunded R34 which demonstrated high feasibility, acceptability in both settings and preliminary effectiveness. Results showed significant improvements in parental monitoring and communication, reduced adolescent: SU days (reductions in binge drinking, all other drug use) and reduced schoolrelated problems in families receiving short-term residential treatment. The research team is outstanding. The timing of delivery, the elements included (video, telehealth), and the testing of mediators of treatment effects of Parent SMART are innovative. The approach is rigorous including the measures used, plan for randomization, statistical analyses, and measures of SU with urine tests. Some concerns in the approach include the length of assessments, the inclusion of parents who complete all available counseling sessions, and the self-reported measure of alcohol use. Overall, this project is needed in this high-risk population, it is rigorous as it is backed up by strong pilot data, and it is likely to be effective in achieving planned outcomes.

Strengths
• This research is significant as adolescents in residential SU treatment have the highest rates of SU disorders and high rates of related psychological, behavioral and other sequelae. Rates of relapse within 90 days after discharge from residential SU treatment is as high as 60%.
• The rigor is high as Parent SMART has been tested in both short-and long-term residential facilities in a NIDA-funded R34 which demonstrated high feasibility, acceptability in both settings and preliminary effectiveness. Results showed significant improvements in parental monitoring and communication, reduced adolescent: SU days (reductions in binge drinking, all other drug use) and school-related problems in families receiving short-term residential treatment.

Strengths
• The research team is outstanding. Dr. Becker (PI) has published three systematic reviews and meta-analyses of treatment approaches for adolescent SU which found that parent-based SU interventions are more effective in achieving SU treatment outcomes compared to adolescentonly approaches. She has clinical experience at the McLean ART program and she has served on relevant advisory boards. • The study team has worked well together and each member has complementary expertise that will add to this project. Weaknesses • None noted.

Innovation:
Strengths IPTA BECKER, S • The timing of delivery and the elements included (video, telehealth) in the intervention are innovative • The testing of mediators of treatment effects of Parent SMART is innovative.

Weaknesses
• The use of mobile apps as interventions is not that innovative in general.

Strengths
• The plan for urn randomization by sex, treatment site and preferred language is sound.
Residential treatment staff are blind to condition.
• 25% of the counseling sessions will be jointly reviewed and 20% will be double coded.
• Based on the R34, a repository of over 150 questions and comments and an answer bank has already been created. This will make it easier to respond to questions from participants in a timely fashion.
• There is high scientific rigor: measures have high reliability (alphas >0.7), the statistical analyses and sample size calculations are rigorous.
• The measures used are validated with good reliability. The plan for statistical analysis is sound.
• Very detailed retention strategies are presented which will likely result in >80% retention rates.
Incentives are generous which will encourage participation and retention.

Weaknesses
• Although mediators of the intervention effects will be examined, there is no conceptual model guiding the study beyond the theory of the social ecology of human development which gives credence to a parent intervention. This is a minor concern since Figure 3 details a conceptual framework that ties the aims and hypotheses.
• Alcohol use will be assessed via self-report.
• The R34 showed greater reductions in MJ in TAU youth which is partially explained. The other SU outcomes were very positive.
• The assessments are very long (adolescents/parents at baseline: 90-120 minutes/45-60 minutes and 60-and 30-minutes follow-up). It may be difficult to get complete compliance of all questions at each timepoint.
• Both participants who complete all sessions or some sessions will be included. Although this will be considered in statistical analysis, the results will likely be very different in the "completers".
• It is not specified what % of the assessments need to be completed or how many of the 3 urine tests need to be obtained in order for data analysis to be conducted.

Strengths
• Research activities will be based at Brown University's Center for Alcohol and Addictions Studies (CAAS). CAAS is home to New England Addiction Technology Center (ATTC) led by the PI, Dr. Becker. This infrastructure and support for this project is very strong. IPTA BECKER, S • Dr. Becker will be able to use the resources and relationships she has established to disseminate study results. These include surrounding treatment centers and hospitals (Bradley Hospital and McLean Hospital).
• There is a strong LOS from Silent Disclosure, the company that will collect and compile metadata to enable analysis of Parent SMART usage and provide ongoing programmatic support. Except for phone numbers and email addresses, no PHI will be accessed by this company and they state they have no COI on this project.

Strengths
• There is a detailed timeline with all study tasks clearly outlined. The proposed dates of accomplishing each task seem feasible. The timeline for recruitment of 220 dyads over 50 months is reasonable.

Protections for Human Subjects:
Acceptable Risks and/or Adequate Protections