Adolescents With Substance Use Disorders Transitioníng From Residential Treatment to the Community
Condition: Substance Use; Adolescent Behavior
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      Adolescents with substance use disorders (ASUD) in residential treatment have the most
      serious substance use disorders and the highest rates of psychological, motivational,
      behavioral, legal, environmental, and vocational problems. ASUD in residential treatment are
      also at high risk of relapse, with follow-up studies suggesting that 60% of ASUD will relapse
      within 90 days of discharge. Parenting practices have been established as a key influence on
      adolescents' initiation and maintenance of substance use, as well as their substance use
      outcomes and likelihood of relapse. However, therapists who treat ASUD have reported a myriad
      of systemic barriers to engaging parents in treatment. Findings such as these deem ASUD in
      residential treatment a high priority population and argue for the value of easily accessible
      parenting interventions during this critical time. The proposed study 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 involves adapting the delivery of a computerized parenting intervention (Parenting
      Wisely; PW) that has preliminary evidence of efficacy in improving parenting skills and
      reducing youth behavior problems. This study adapts the delivery of PW for a new population
      (parents of ASUD) and new setting (residential treatment), and obtains initial data on its
      feasibility, acceptability, and effectiveness. As a first step, an open trial with 10 parents
      was conducted to develop and pilot an adapted version of PW that included moderate engagement
      strategies: in-person coaching sessions, daily text messages containing reminders of
      parenting skills and links to video vignettes, and an online parent forum containing two
      networking boards (Ask an Expert and Connect with Parents). In the current phase, a pilot
      randomized trial with 60 parents will compare an adapted PW plus treatment as usual (TAU)
      condition (PW+) versus TAU only in a residential treatment center. Both treatment conditions
      will be delivered by Bachelor's or Master's-level community clinicians. This small trial will
      provide some initial evidence regarding the utility of a low-cost, low-intensity intervention
      and whether a larger, fully powered trial is indicated in the future.
    

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.
    

Intervention name(s): Parenting Wisely+; Treatment as Usual
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Parenting Wisely+ experimental intervention; Treatment as Usual
Other intervention name(s): Parenting Wisely; PW
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: adolescent; substance use