Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03592186 |
| Other study ID # |
1802001981 |
| Secondary ID |
R34DA039289 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2017 |
| Est. completion date |
February 28, 2020 |
Study information
| Verified date |
December 2021 |
| Source |
Brown University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
