Experimental Mediation Research Aimed at Enhancing Adolescent Substance Abuse Treatment
Phase: NA
Conditions: Substance Use Disorders
Sponsor: Oregon Social Learning Center

Study Protocol and Statistical Analysis Plan 
Enhancing Adolescent Substance Abuse Treatment 
NCT03249350 
PI: Mike McCart, PhD; Oregon Social Learning Center 
08/17/2017 
 

SCIENTIFIC RIGOR 
The proposed study will achieve robust and unbiased results via several features, including a priori 
hypotheses; explicit inclusion/exclusion criteria; use of well-established measures and multi-method validation 
of primary constructs; ensuring data collection staff are blind to treatment assignment; carefully delineated data 
analysis plans; power estimates; and plans for retention, missing data, and potential confounds. Biological 
variables (age, sex) are incorporated into the analytic plan. Study details are reported in a transparent way to 
support replication, and investigators expose results of all their studies to high quality peer-review procedures. 
PRELIMINARY STUDIES 
Several areas of past work culminate in this proposal: (a) mediation studies and research on the proposed 
direct (parent management) and indirect (behavioral regulation, peer relations) targets, (b) clinical research 
involving family-based CM and other EBPs, and (c) dissemination research with CM and other EBPs.  
STUDIES INVOLVING THE PROPOSED TARGETS AND MEDIATORS OF EBPS.  
PARENTING AND PEER RELATIONS. The PI and Co-I’s have collaborated on many studies evaluating parent 
management, as well as numerous studies evaluating peer relations and impacts on youth behavior (see 
Biosketches). In fact, the Oregon Social Learning Center (OSLC) and the PI’s former institution, the Family 
Services Research Center (started by Co-I Henggeler), are internationally known for their contributions to 
studying parenting, peer relations, and high-risk youth. Thus, the team is optimal for leading this research.  
NEUROCOGNITIVE PROCESSES UNDERLYING BEHAVIORAL REGULATION. For over a decade, OSLC researchers 
have examined the effects of stress on youths’ neurocognitive functioning. Co-I Bruce has expertise in 
acquisition, analysis, and interpretation of data measuring risk taking and inhibitory control abilities in 
adolescents.119–123 She also has expertise with neurobiological measures collected in studies of foster care and 
a family-based school readiness intervention for at-risk youth.28,124–125 Of importance, results from studies 
employing event-related potential and event-related functional magnetic resonance imaging suggest parenting 
interventions can alter the neural systems underlying behavioral regulation.28,124,126 Bruce, therefore, is well 
equipped to guide examination of the putative mediating effects of risk taking and inhibitory control.  
MEDIATION OF EBPS. Several trials conducted by the team have produced papers examining mediators of 
experimental interventions.94-95,127–128 For one manuscript,127 McCart and Chapman co-led the complex mediation 
analyses. Thus, the team is equipped to accomplish the proposed work. The approach to mediation 
(experimental mediation) is a unique innovation, although the methods integrate standard RCT and data 
collection techniques with which the team has vast experience. However, to further strengthen the team’s 
expertise, David MacKinnon, a leading experimental mediation expert, will serve as a consultant. 
CLINICAL RESEARCH INVOLVING FAMILY-BASED CM AND OTHER EBPS.  
RCTS AND IMPLEMENTATION EFFORTS INVOLVING FAMILY-BASED CM. As noted, family-based CM is one of 
several validated adolescent interventions.13 A variation of family-based CM developed by Azrin, Donohue et al. 
produced positive results in several studies.32–33,129-130 Following that work, our team conducted an RCT, in 
collaboration with Donohue, evaluating CM combined with MST for substance abusing juvenile offenders.55 More 
recently, our team collaborated on an RCT integrating family-based CM into juvenile drug courts,34 as well as the 
aforementioned RCT comparing CM and an HIV-risk reduction protocol to TAU for delinquent youth.107,131 Study 
results have demonstrated significantly better outcomes for youth in CM conditions relative to controls; however, 
treatment effects have tended to fall in only the small to medium range.34,107 
With extensive understanding and use of Instructional Design Theory (advocated by educational 
researchers132-134), the investigative team has focused on developing family-based CM suited for training and 
implementation in real world settings. In fact, McCart and Sheidow started a clinic at their prior institution that 
utilized Master’s level practitioners to deliver CM to the local community and have developed a similar capacity 
at their current institution’s clinic. Aside from studying its effectiveness, the team has extensive knowledge on 
implementation of CM, a requisite for the proposed study. Specifically, the team has experience with: (a) the 
range and magnitude of incentives for youth, (b) developing reward systems that leverage the empirically 
demonstrated impact of escalating reinforcers and rapid resets (a “leveled” system),135–136 and (c) blending 
immediate reinforcers (immediate access to most valued privileges) with a token economy system (accruing 
points to purchase from individualized and varied reward/privilege menus). With this experience delivering family-
based CM in clinical research and real-world practice settings, the team is primed for the proposed trial. 
RCTS AND IMPLEMENTATION EFFORTS INVOLVING OTHER EBPS. The PI and Co-I’s also have conducted 
numerous RCTs on interventions other than family-based CM. For example, McCart, Sheidow, and Chapman 
are collaborating on RCTs of interventions for victims of child sexual assault (R01DA031285) and youth with 
comorbid mental health and substance use problems (R01DA025616). Further, Henggeler has 3+ decades of 
experience conducting RCTs on MST and other family-based youth treatments (e.g., several RCTs with violent 
juvenile offenders,137-139 two with substance abusing juvenile offenders,34,55 and one for youth with serious 
emotional disturbance140). Similarly, Chamberlain conducted several RCTs of TFCO for antisocial youth.141-142  
Of note, these trials all included close collaboration with community agencies, random assignment, 
evaluation of multiple outcomes, and minimal exclusion criteria to enhance external validity. These trials also 

had diverse samples (e.g., up to 32% Latino, 81% African American, 12% Native American) and high recruitment 
rates (see details in Recruitment and Retention Rates section). Thus, the investigators are skilled at 
implementing intervention protocols, recruiting diverse youth and families into clinical research, executing data 
collection protocols, and performing advanced data analyses to answer research questions. 
DISSEMINATION RESEARCH WITH FAMILY-BASED CM AND OTHER EBPS.  
The study also is supported by our work transporting CM and other EBPs to community settings. The 
investigators completed several NIDA-funded studies examining CM transport to the public sector including: a 
study of quality assurance on CM fidelity among providers in Connecticut117 and a replication in Norway;143 a 44-
site Statewide Study on training 432 therapists in CM and examining their adoption;35–36 and a CM Training Study 
evaluating relative effectiveness of different training methods among 100+ public sector therapists.144 Findings 
from the Statewide Study indicated strong interest, with 80% attending a workshop and 58% adopting CM. 
Adoption was related to individual characteristics and attitudes toward EBPs; negative attitudes toward CM was 
not a barrier cited. Other investigators have examined transportability of CM to community settings and found 
high adoption rates.145-147 The team also has researched transportability of other EBPs. For example, Sheidow 
and Chapman collaborated with Sonja Schoenwald on a 45-site MST transportability study, which indicated (a) 
a complex intervention can be transported to community-based therapists, (b) fidelity predicts outcomes, and (c) 
clinician and organizational factors affect fidelity and outcomes.148 
CONCLUSION. The team has extensive experience evaluating and transporting EBPs. Our research suggests 
that while family-based CM is a well-validated EBP for adolescent SUD, its effects, like other adolescent SUD 
EBPs, are modest. Thus, this study will use an experimental mediation approach to identify mediating processes 
in treatment, with the ultimate aim of improving SUD treatment effectiveness. Backed by our experience 
conducting mediation and clinical studies, this study is poised to produce crosscutting implications for improving 
youth SUD treatments. Given the clear need to enhance effectiveness and durability of existing interventions, 
such work could have a dramatic impact on outcomes and services for youth. 
DESIGN TIMELINE AND 
OVERVIEW  
 Data will be from a 
longitudinal 
two-
armed parallel group 
design with 172 youth 
randomized to CM vs. 
CM+. 
In-person 
assessments will be at 
baseline, 2-, 4-, 6-, 9-, 
and 12-months post-
baseline. 
Phone 
assessments will be at 
1-, 3-, 5-, 7-, and 8-
months post-baseline. 
STUDY SITES 
The proposed study will be conducted with the OSLC outpatient clinic and Centro Latino Americano (CLA). 
Both are Medicaid-approved, HIPAA-compliant clinics employing Certified Alcohol and Drug Counselors (CADC) 
to deliver treatment services. While the two clinics serve all Lane County residents, CLA clients are 
predominantly Latino. As noted in the Introduction, adding CLA as a second site for this trial allows for 
oversampling of Latino youth, permitting an examination of differential mediation effects by ethnicity (see Data 
Analysis). Importantly, OSLC scientists regularly collaborate with OSLC clinic staff on intervention trials involving 
methods consistent with the proposed study. Similarly, OSLC scientists have a long history of collaborating with 
CLA on research and implementation projects.149-150 Thus, the sites are optimal for ensuring adequate 
recruitment numbers, protocol fidelity, and successful completion of study procedures. 
The trial will involve 6 CADCs across the sites; 3 CADCs (2 from OSLC and 1 from CLA) will be randomly 
selected to deliver CM+ and the other 3 CADCs (2 from OSLC and 1 from CLA) will deliver standard family-
based CM. Based on our experience with RCTs, we anticipate turnover and have planned for as-needed 
recruitment of new CADCs and case re-assignment to ensure cases remain within condition. To ensure high 
fidelity and reduce confounding variables (e.g., access, insurance), the study will pay for treatment in both 
conditions, and investigators will train and closely monitor CADC staff.  
Adolescents presenting to OSLC and CLA for SUD treatment during Study Months 7-42 will be screened, 
and those meeting inclusion criteria will be offered the opportunity to participate pending available slots. Power 
calculations (presented subsequently) indicate an optimal sample size of 172. Given case flow at the clinics, and 
our desire to oversample Latino families, we anticipate achieving the required sample size in 3 years. Specifically, 
CLA treats 23 adolescents with SUD per year on average, and all of these will be approached to participate in 

the trial. Assuming an 80% recruitment rate (see subsequent rationale for this rate), we expect to recruit 55 
families from CLA across the 3 years. OSLC serves just over 100 cases/year on average, so case flow will 
provide more than enough families to recruit the remainder of the sample (49/year x 3 years = 117). Based on 
information from OSLC and CLA, the following demographic characteristics are expected for youth recruited 
across both clinics: average age = 15 years (range = 12-17 years); 84% White, 13% African American, 2% 
American Indian/Alaska Native, 1% Asian; 35% Latino (of any race); and 30% female. 
PARTICIPANTS 
Participants will include 172 youth and their primary parent/guardian. Inclusion criteria for the youth are: 1) 
age 12-17 years; 2) presence of current SUD; and 3) availability of a parent/guardian willing to participate. 
Exclusion criteria are: 1) actively psychotic, suicidal, or homicidal; and 2) PDD or mental retardation. To increase 
external validity, youth will be included regardless of co-morbid mental health or physical difficulties. 
RESEARCH SCREENING, RECRUITMENT, AND RETENTION  
INITIAL SCREENING. All cases presenting to the OSLC and CLA clinics meet initially with an intake worker to 
determine appropriateness for an outpatient level of care. The intake worker will make a preliminary 
determination regarding study eligibility and refer them and their parents to Project Assessors.   
STUDY RECRUITMENT AND SCREENING. Assessors will meet with youth and parents at a time and place 
convenient to the family (clinic, family’s home, private community location) to obtain parental consent/youth 
assent. Protections will be assured, including IRB approval and a federal Certificate of Confidentiality. After this, 
SUD will be confirmed via the Global Appraisal of Individual Needs-Initial, Lite (GAIN-I, Lite),151-154 a diagnostic 
interview aligned with the DSM-5. If lacking a SUD, youth and parents will each be provided $10 gift cards. If 
SUD is present, a 2-hour baseline interview will be conducted and subsequent interviews scheduled. 
RECRUITMENT AND RETENTION RATES. In over 15 years conducting treatment research with families, we have 
achieved recruitment rates ranging from 85-100% and retention rates exceeding 90% for 12-month follow-
ups.34,55,107 The research team has been very successful at recruiting and retaining participants from challenging 
populations, and the majority of these studies were conducted in real world (rather than research) clinics where 
youth/families could receive treatment without consenting to research. We will replicate our successful 
recruitment and retention strategies in this trial. First, to establish collaborative relations with families, 
assessments are scheduled at their convenience, contacts are as friendly as possible, and families are 
reimbursed for their time. Second, direct contact helps maintain the cohort, with families contacted regularly 
during their 12 months of study participation. At each contact, families are asked if they plan to move and for up 
to 4 phone numbers and email addresses of best friends, relatives, and schools/places of employment. Third, 
we obtain consent to use technology such as text messaging and Facebook (using private messaging functions). 
When participants cannot be located, Assessors track them using the various contacts, other Internet resources 
(e.g., reverse look-up), and post office forwarding. Fourth, the same Assessor follows participants over time to 
encourage rapport. Fifth, contacts are defined as confidential and independent of treatment. Reasons for missed 
interviews will be recorded to assess impact on proposed methods. 
RANDOMIZATION TO CONDITIONS  
An adaptive urn randomization procedure,155-158 implemented using the Microsoft Access application gRand, 
will balance potential confounding variables among participants randomized to each condition and also will 
manage condition sizes. This method is recommended for trials of SUD treatments.155 Based on the population 
and outcomes of interest, factors on which the urn will operate are youth age, sex, baseline substance use 
severity, and a weighted percentage schedule for condition balance. The urn will minimize variability in these 
pre-treatment variables across the two conditions. To keep Assessors blind to condition, the Assessment 
Coordinator will conduct the randomization procedure immediately following a family’s baseline assessment and 
will convey results directly to parents. The Coordinator also will inform the clinic intake worker of the 
randomization result so the family can be assigned to a CADC in the correct condition: CM+ or CM only.  
DATA COLLECTION PROTOCOL 
Assessors will meet with youth and parents for (1) a 2-hour, in-person baseline interview, (2) in-person, 1.5-
hour follow-up assessments at 2-, 4-, 6-, 9-, and 12-months post baseline, and (3) 30-minute phone interviews 
at 1-, 3-, 5-, 7-, and 8-months. If youth and parent have to be assessed at different sessions, they will be 
scheduled within one week of each other. This schedule provides frequent measurement of constructs during 
active treatment (both CM+ and family-based CM are expected to last 5-6 months on average), while also 
providing a longer view on durability of change than is typical in adolescent SUD treatment research.19  
To compensate for their time, families are paid $50 for baseline and $40 for each in-person follow-up 
assessment. Families will be paid $10 for each brief telephone assessment (maximum total compensation = 
$300). Based on our experience, 1.5- to 2-hour assessments rarely present a significant response burden, but 
Assessors are trained to use breaks with snacks and to attenuate circumstances that threaten validity of 
assessments. Participant protections are detailed in the Human Subjects Protocol and include IRB approval. 
MEASURES 
Multiple methods or perspectives will enhance construct validity. Consistent with intention-to-treat principles, 

data from all time points will be collected even if families drop out of treatment. 
Table 2. Research Instruments 
Descriptive Variables [Baseline only] 
Structured Adolescent Interview159 for demographics and to supply relevant data for the urn randomization. 
Ultimate Outcomes [Months 0, 2, 4, 6, 9, & 12] 
SUBSTANCE USE: 
   Urine samples collected by researchers from youth; lab testing for THC, synthetic THC, amphetamines, opiates, PCP, cocaine, and 
alcohol metabolites (EtG/EtS); selected lab’s testing procedures are of high scientific quality. 
   GAIN151-154 scales measuring self-reported youth substance use and substance-related problems; 16-item substance abuse 
index/substance dependence, substance problem scales assessing DSM-5 criteria for substance use disorders and lower severity 
symptoms, recovery environment risk and social risk subscales that predict substance-related problems in youth with substance 
abuse, and the substance frequency scale assessing substance use for past 90 days; GAIN scales have good reliabilities and 
sensitivity to change, and are highly associated with results from Form-90 and urine testing.160-161 
EXTERNALIZING BEHAVIOR: Externalizing subscale of parent-completed Child Behavioral Checklist and corresponding subscale 
of Youth Self Report;162 scales provide valid measures of youth externalizing behavior from multiple perspectives.163  
Direct Target [Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, & 12] 
PARENT MANAGEMENT: 
   Alabama Parenting Questionnaire (APQ)164 administered to youth and parents, measuring monitoring/supervision, positive 
parenting (social/tangible reinforcement), and consistent discipline (removal of privileges); scales have been used to document 
treatment outcomes and distinguish families of youth with and without behavior problems;164 scales have established reliability and 
validity;165 an additional rules and expectations subscale added to the APQ assesses enforcement of household rules. 
   CM Adherence Measure (CAM) developed using Rasch methods and validated across several studies with substance using 
adolescents;37,166-167 subscales measure cognitive behavioral (antecedent-behavior-consequence assessments, self-management 
planning) and behavioral (drug screening, contingency contracting) techniques used within family-based CM. Originally, this tool was 
designed for families to rate their therapist’s delivery of CM in session. However, as noted previously, a central feature of CM is to 
train parents to continue implementing CM at home. Thus, for this study, parent and youth CAM reports will be obtained to assess 
parents’ implementation of CM both between the sessions and after treatment has ended. 
Indirect Targets [Months 0, 2, 4, 6, 9, & 12] 
PEER RELATIONS: Pittsburgh Youth Study111 scales with strong reliability and validity;168 youth-reported peer delinquency scale 
and drug activity scale measuring proportion of youths’ friends who engage in antisocial behaviors per youth report, youth-reported 
conventional activities of peers scale measuring proportion of friends who engage in prosocial activities, and bad friends scale 
assessing youth contact with peers disapproved of by parents per youth and parent report. 
BEHAVIORAL REGULATION - RISK TAKING:  
      Behavioral Inhibition System (BIS) and Behavioral Activation System (BAS) Scales completed by youth and parents;169–170 
BIS is sensitive to signals of punishment and non-reward; BAS is sensitive to signals of reward; BAS includes three subscales: drive 
(persistent pursuit of desired goals), fun seeking (spontaneous desire for new rewards), and reward responsiveness (positive 
responses to the anticipation of rewards); scales have satisfactory reliability and validity.169–170  
      Balloon Analogue Risk Task - Youth assesses risk-taking propensity.81,171 Adolescents earn points every time they pump to 
inflate a computer-generated balloon, a computer algorithm randomly determines the number of pumps that will cause the balloon to 
pop, and the adolescents lose points if the balloon pops. An index of risk taking is calculated by averaging the number of pumps for 
balloons that did not explode.81 The task has good internal consistency and convergent validity.81 
BEHAVIORAL REGULATION – INHIBITORY CONTROL: 
   Early Adolescent Temperament Questionnaire–Revised172–173 completed by youth and parents; scales include inhibitory control 
and higher-order factors: effortful control, negative affect, affiliativeness, extraversion; good internal consistency.173 
   Go/No Go Task of inhibitory control; youth selectively respond to target stimuli and inhibit responses to equally salient, non-target 
stimuli.121,174  Consists of 252 trials: a letter is presented for 500-ms with a fixed, 1,500-ms interstimulus interval. Youth is instructed 
to press button as quickly as possible for every letter (go stimuli) except X (no go stimuli); 75% “go” trials and 25% “no go” trials; 
activates dorsolateral prefrontal cortex, ventral prefrontal cortex, and anterior cingulate cortex.174 Consistent with prior research,175–
176 we will compute an index of inhibitory control: subtract percent correct on highly interfering stimuli (“no go” trials) from percent 
correct on minimally interfering stimuli (“go” trials). Lower scores indicate better inhibitory control. 
TREATMENT CONDITIONS  
FAMILY-BASED CM. Family-based CM is rooted in behavioral and cognitive behavioral theories and is 
designed for delivery in outpatient clinic settings (weekly 50-60 minute sessions). Treatment duration is criterion-
based, determined by achievement of substance use goals, but the protocol is typically 5-6 months (20-24 
sessions). CM has strong empirical support in the adult SUD treatment literature,177 and family-based CM has 
also proven efficacious for youth SUD.13,178 Moreover, its relative simplicity and low cost179 makes family-based 
CM highly amenable to adoption. The protocol components are listed in Table 3.  
Table 3. Family-Based CM Components 
Clinical assessment. A semi-structured interview conducted separately with the youth and parent gathers type, frequency, quantity, 
and administration route of drug use; and data on treatment, medical, and educational history. 

Introducing CM. CM is introduced to the youth and parent, and the therapist begins to engage them both in treatment. 
Antecedent-behavior-consequence (ABC) assessment. ABC assessments of the youth’s substance use are conducted in 
collaboration with the youth and parent (similar to functional analyses), in which they are asked to identify environmental, cognitive, 
and affective triggers (i.e., antecedents) for recent episodes of use or abstinence and to reflect on both the positive and negative 
consequences of that use/abstinence. ABC assessments are completed in each session, but parents and youth also are trained to 
complete these together as homework following each drug test completed at home (see below).  
Self-management planning. The triggers identified in ABC assessments are targeted via self-management plans developed by the 
therapist, youth, and parent. Plans commonly fall into three categories: (a) avoiding triggers (e.g., avoiding certain peers, decreasing 
time spent in places/with people that trigger use while increasing time spent in places/with people that trigger abstinence), (b) 
rearranging environment (e.g., purging items associated with drug use), and (c) developing effective drug refusal skills for unavoidable 
triggers such as peer pressure. Once a list is generated, the therapist helps the youth and parent weigh the potential costs, benefits, 
and difficulty level of each strategy so they can choose the best plan.  
Drug testing and contingency contracting. Concurrent with developing self-management plans, parents are taught to conduct 
random urine drug screens and breath scans at home. Screens also are conducted at every scheduled treatment session. Finally, 
the therapist and parent arrange for periodic random clinic visits to conduct screens. The therapist, youth, and parent create a 
contingency contract that specifies consequences based on the results of the screens. 
     The contingency contract follows a well-specified protocol for behavior plans. First, the therapist, youth, and parent generate a 
menu of rewards that can effectively compete with the youth’s substance use. The therapist ensures there is a balance between 
natural incentives parents can provide (e.g., cell phone access; later curfew) and items to be purchased with gift cards (i.e., therapists 
have access to $250/youth for gift cards). To assist therapists and parents in identifying rewards with the best odds of competing with 
substance use, rewards are rank ordered by the youth based on preference. From this reward menu, the youth and parent choose 
the youth’s “most valued privilege” (MVP), which is almost always a natural incentive a parent can provide regularly. Remaining menu 
items are assigned point values by the parent and therapist, usually 1 point ≈ $1. Once the menu is finalized, a point-and-level system 
is implemented and the youth receives a 50-point starting balance. The youth earns or loses MVP access from the parent depending 
on each drug screen result. During the first month (Level I of the contract), youth keep their points if they have negative drug screens, 
but lose 12 points for each week they test positive. Regardless of screen results, youth cannot redeem their points in this period. 
From the fifth week on (Level II of the contract), negative screens result in youth being able to earn additional points and also to use 
their points to “purchase” items on the reward menu. To provide a greater incentive (i.e., escalating reinforcer), the number of points 
youth can earn each week starts at 12 and then increases to 24 after eight consecutive weeks of negative drug screens (Level III of 
the contract; rapid reset is also used). When making a purchase, youth may use as many points as they would like from their balance. 
Rewards are provided as immediately as possible, consistent with behavioral principles. If a youth has a positive screen from the fifth 
week on, the youth does not earn points and cannot make a “purchase” until the next negative screen. As treatment progresses, 
emphasis shifts to using natural incentives provided by parents to sustain abstinence and also expansion of the behavior plan to 
include any other behaviors the parent wants to target. 
CM+ TO ENHANCE PARENT MANAGEMENT. As discussed, although family-based CM involves parent 
participation, evidence indicates it does not yield reliable improvements in parent management skills. Consistent 
with the enhancement manipulation-of-mediator design, an approach was chosen to target the putative parenting 
mediator more intensely in CM. In selecting the approach, the following criteria had to be met. It needed to be: 
(a) powerful enough to generate meaningful changes in parenting, (b) conceptually consistent with CM, and (c) 
feasible for delivery in outpatient settings. Various approaches were considered, and the well-validated 
behavioral assessment and teaching system from PMTO2 was ultimately chosen. This system was selected for 
three reasons. First, PMTO is supported by five decades of efficacy, effectiveness, and implementation research, 
and it is the leading parent training intervention for youth.180 Indeed, evaluations of PMTO with child and 
adolescent samples demonstrate it produces substantial reductions in youth externalizing behavior.181  Second, 
and of central importance to the present proposal, mediation studies indicate that the behavioral assessment 
and teaching system in PMTO produces improvements in parent management skills, and those improved skills 
largely account for PMTO’s effects on youth outcomes.180 In fact, of all parenting interventions, PMTO has the 
most support for improved parenting as the key mechanism of action.180 Third, PMTO has been extensively 
tested and validated for use with diverse samples, including Latino families.182  
PMTO was developed and validated by OSLC scientists in the 1970s, and this EBP is currently being 
implemented in over 100 national and international sites.2 The model is comprised of a behavioral assessment 
and teaching system as well as clinical content. In PMTO, the clinical content is typically behavioral concepts 
focused on externalizing problems, but can be tailored by subpopulation. Thus, CM strategies (detailed above) 
can be the clinical content. PMTO’s behavioral assessment and teaching system was developed as the specific 
therapeutic processes used to deliver the clinical content and the system is viewed as critical to achieving 
PMTO’s meaningful change in parenting.182 In essence, the system involves “parallel processes” in that it 
employs behavioral principles, the same behavioral principles employed to change the child’s behavior, to 
facilitate parents’ active learning and rapid skill acquisition. As such, the PMTO behavioral assessment and 
teaching system can be seamlessly adopted by other conceptually consistent interventions. Indeed, Co-I 
Chamberlain has incorporated this system into both TFCO183 and KEEP.184 Similarly, with oversight from 

Chamberlain, the CM+ protocol will add the behavioral assessment and teaching system from PMTO to standard 
CM to enhance parent’s skill acquisition more intensely (see Table 4).  
Table 4. PMTO Behavioral Assessment and Teaching System Incorporated Into CM 
This system uses three fundamental Processes (listed below) to bring about changes in parenting. These processes are 
interdependent therapeutic operations,185 forming the fundamental skills a therapist employs. The basis for these processes is to 
address a youth’s behavior problems using methods based on behavioral principles to change the parent’s behaviors. These 
processes are the therapeutic skills used to deliver clinical content (i.e., to assess and teach parent management) and are based on 
principles of behavioral chaining, shaping, fading, generalization, immediacy, reinforcement, differentiation, cueing, and modeling. 
Parent Daily Report (PDR1). The PDR procedures entail highly structured phone calls to the parent. Although the PDR typically 
includes daily phone calls, we believe it would be more feasible and prevent potential barriers if phone calls were conducted every 
other day (i.e., approximately twice between sessions). Calls are pre-arranged to occur at convenient times for the parent. Parents 
are oriented to PDR procedures so they are prepared for how the structured call will be conducted. First, the therapist ensures the 
parent can speak confidentially (ensure privacy). The therapist then asks a series of brief questions assessing occurrence/non-
occurrence during the past 48 hours of specific adolescent behaviors (e.g., adherence to rules, substance use confirmed by urine 
drug screens), parental responses to those behaviors (e.g., reinforcement, limit setting, supervision), and the youth’s reactions to the 
parental response. The therapist then offers guidance and feedback (cueing) to parents on effective parent management techniques. 
These include breaking complex parenting behaviors into smaller steps (behavioral chaining) and providing positive feedback 
(reinforcement) in proximity to specific parent management accomplishments (immediacy). Rather than focus on all parenting 
behaviors, the parenting behaviors (including smaller steps in the behavioral chain) are rank ordered by the therapist prior to the calls 
so the therapist can focus on a single parenting behavior for each phone call (based upon the combination of prioritization and 
occurrence/nonoccurrence of behaviors; fading and shaping of parent management skills). The therapist also graphs parenting 
behaviors based on PDR data collected in each call; the graph is used to illustrate progress during in-person treatment sessions. 
Research indicates that when implemented with other behavioral interventions, the PDR is highly feasible and has good utility for 
improving parent management skills.186-189 Also of importance, the PDR is easy to implement and fits within the practice parameters 
of outpatient therapists (contacting and guiding parents in specific skills related to the youth’s treatment).  
3-D Role-Play. Therapists are trained in this method to help parents develop and refine the use of parenting skills. Although role-play 
is not a new technique, OSLC scientists developed the 3-D method in collaboration with Salvador Minuchin (developer of Structural 
Family Therapy) to enhance its capacity as a teaching tool.190 The therapist first meets individually with the parent to Demonstrate an 
ineffective response to a problematic youth behavior, such as lecturing. Next, the therapist models a more effective strategy, such as 
swiftly implementing a consequence in a calm voice, to Differentiate it from the ineffective approach (differentiation and modeling). 
Finally, the therapist and parent Debrief to consider positive and negative consequences of the ineffective and effective strategies. 
Reflective questioning during debriefing increases parents’ awareness of how their verbal and nonverbal behaviors influence 
interactions with their youth (cueing). For example, therapists might ask, “What did I do to make you want to cooperate? How was my 
tone of voice?” Such 3-D role-plays are used in every session to facilitate step-by-step learning of complex skills (behavioral chaining), 
with each step representing a small change that contributes to successful implementation (shaping). Once a parent becomes proficient 
with a skill, s/he is assigned homework to try it in real-life situations (generalization). After opportunities for testing, skills are revisited 
during sessions and PDR calls and refined for future application (generalization).  
Anti-Coercive Problem-Solving. Teaching a parent to change his/her parent management skills requires instruction. A collaborative 
problem-solving approach was developed based on research indicating that parental resistance to this instruction (a high base rate 
phenomenon in parenting interventions) can be exacerbated or abated by therapist responses.191 Instead of straightforward 
instruction, therapists are trained to demonstrate (modeling) problem-solving steps (identifying goal statements, brainstorming options, 
identifying manageable steps to achieve goals) and to use those steps as clinical skills to prevent or manage resistance. Problem-
solving begins in the first session as therapists help parents articulate goals for their child’s treatment. Parents learn to break goals 
into small achievable steps (behavioral chaining), and progress is tracked and praised at every session (shaping and reinforcement). 
Brainstorming becomes a strategy to engage parents and manage resistance. For example, if parents express doubt about their ability 
to complete a task, such as withholding an MVP if their youth tests positive for drugs, the therapist avoids engaging in a coercive 
interchange and collaboratively brainstorms solutions instead. Parents might decide to solicit assistance from another adult family 
member in withholding the MVP or decide to change the MVP to an item they can more confidently withhold (shaping). Thus, active 
problem-solving is always emphasized. Further, because behavior plans rarely work perfectly on first attempts, therapists provide 
strategic warnings to help parents anticipate that their plans might need revision (cueing). This approach increases parents’ comfort 
in reporting challenges with implementing a behavior plan. Whenever this occurs, the therapist emphasizes positive aspects of the 
parent’s effort at implementing the plan (shaping) while identifying areas for refinement, helping the parent create a new plan, and 
rehearsing new skills via role-play practice, as needed.  
Of importance, our team’s decades of clinical experience with the PMTO behavioral assessment and 
teaching system supports feasibility of implementing it as part of CM+. Indeed, OSLC staff implement the PDR 
each day with hundreds of foster parents participating in TFCO throughout the U.S., with PDR completion rates 
ranging from 70-100%. In addition, the behavioral assessment and teaching system is actively being utilized in 
programs at the OSLC outpatient clinic. As an example, for over seven years, OSLC therapists have served a 
population of parents referred by child welfare due to serious substance abuse and neglect of their children. As 
a central component of that outpatient treatment, therapists administer PDRs to parents every other day 
(consistent with the proposed CM+ schedule) and use the PMTO role-play and problem-solving strategies to 
enhance parents’ delivery of effective parent management skills. OSLC staff have achieved a PDR collection 

rate of 79% and a treatment completion rate of 81% with these high-risk substance-abusing parents, highlighting 
the feasibility of delivering these strategies in an outpatient clinic.  
ACHIEVING AND ASSESSING FIDELITY. Treatment fidelity is essential for internal validity (ensuring standard 
family-based CM and CM+ are implemented as intended and differ from one another only with regard to the 
experimental enhancement). Thus, strong treatment fidelity is critical to establishing effectiveness, and a well-
developed protocol will be used for training and ongoing quality assurance. Specifically, therapists in both 
conditions will receive training and ongoing quality assurance from McCart and Sheidow. The training protocol 
follows that used in our other family-based CM research and large-scale transport of CM to community-based 
practitioners.35–36 An initial 3-day workshop orients clinicians to program philosophy and all intervention methods. 
Clinical supervision further supports therapists’ implementation, modeled on a structured CM supervisory 
manual.192 Following workshop training, clinicians practice treatment delivery to families and have individual 
supervision weekly to review progress and problem-solve barriers. As high fidelity becomes consistent, weekly 
phone coaching is provided, focusing on fidelity and solutions to difficult clinical problems. Bi-annual booster 
trainings are conducted on difficulties in fidelity or achieving clinical outcomes.  
Further, therapist implementation of interventions will be measured from the perspective of the youth, parent, 
and therapists (via self-report) and McCart and Sheidow (via coding of taped treatment sessions and PDR calls). 
As noted, the 34-item CM Adherence Measure (CAM) was developed using Rasch methods and validated across 
several studies.166 CAM subscales measure the cognitive behavioral and behavioral interventions used in CM. 
Using the same format, items will be created to capture PMTO enhancements in CM+. Using standard 
procedures employed in our other CM studies, parents and youth will complete CAMs monthly by phone (for 
duration of treatment) to report on therapist’s CM implementation. Investigators will monitor CAMs monthly for 
ongoing quality assurance and as-needed therapist remediation. In addition, a more immediate fidelity 
assessment and remediation mechanism will be therapists completing CAMs after each session and phone call 
to report on their own behavior. Further, therapists will record all treatment sessions and phone calls. McCart 
and Sheidow will complete observational ratings167,193 on randomly selected (20%) treatment sessions and (20%) 
calls. Employing procedures used successfully in Azrin et al.129 to monitor and improve fidelity, ratings will be 
compared to therapist report from the same session/call. Inconsistencies between therapist self-report and 
observational ratings will trigger remediation training and more intensive supervision. Session/call notes and 
reports also will be evaluated weekly to ensure fidelity across conditions.  
BALANCING THERAPIST CHARACTERISTICS ACROSS CONDITIONS. We anticipate that 3 therapists will deliver CM, 
and 3 different therapists will deliver CM+. Prior to beginning youth recruitment, therapists will be randomized to 
provide services in either the CM or CM+ conditions. To minimize bias, therapists will be balanced as much as 
possible, given the small sample, by age, sex, race, and years of experience. 
ADDRESSING RISK OF CONTAMINATION. Both treatment arms are conducted within a clinic, raising concerns of 
potential contamination between therapists in the same clinic. Nevertheless, based on our experience conducting 
RCTs, we view this risk as low. Indeed, CM and the PMTO enhancements are highly structured, requiring initial 
training and supervision specific to identifying barriers to treatment fidelity. Across numerous trials for similar 
interventions, we have found therapist fidelity varies.194-196 More generally, research indicates even experienced 
therapists revert to prior/usual practice in the absence of formal structures such as ongoing supervision.36 Thus, 
it is unlikely that a standard CM therapist who inadvertently hears about PMTO strategies would be able to 
implement them with fidelity, especially in the absence of training or access to materials and supervision. 
Nevertheless, contamination risk will be mitigated in several ways. First, therapists deliver treatment in only 1 
condition. Second, only therapists within the condition have access to resources to facilitate implementation. 
Third, clinical supervision is conducted individually, not in groups. Fourth, therapists formally agree not to discuss 
CM and CM+, except with therapists in the same condition. Fifth, as described, we measure implementation in 
both conditions, allowing close monitoring for potential contamination during the trial. Any evidence of 
contamination will be addressed immediately with therapists. 
DATA ANALYSIS STRATEGY 
 
The design leads to 11 measurements of the direct target (parent management; level-1), 6 measurements 
of indirect targets (behavioral regulation, peer relations; level-1), and 6 measurements of ultimate outcomes 
(substance use, externalizing behavior; level-1) nested within 172 youth/parents (level-2). Analyses will use 
latent growth curve formulations of mixed-effects regression models.197-198 These highly flexible models 
accommodate variability in number and spacing of measurements, discrete (i.e., urine drug screens [UDS]) and 
continuous (i.e., parent management, behavioral regulation, peer relations, GAIN scores, externalizing behavior) 
outcomes, and separate patterns of change for distinct phases (i.e., during- and post-treatment). 
 
EXPERIMENTAL MEDIATION AND CAUSAL INFERENCE. The experimental mediation design emphasizes evidence 
supporting causal inferences, and there are important conceptual and statistical considerations. As reviewed by 
MacKinnon,199 by randomizing youth/parents, the effect of CM+ on parent management is a causal estimate. 
However, the effect of parent management on drug use and externalizing behavior is not straightforwardly 
causal, it is potentially influenced by unmeasured confounding variables. Following MacKinnon’s 

recommendations, and to support causal inferences, this is addressed in 3 ways. First, the enhancement design 
directly targets the mediator—increasing probability of a causal effect between mediator and outcome. Second, 
longitudinal measurements of the mediator and outcomes address temporal sequencing—demonstrating that 
mediator effects occur before outcome effects. Third, supplemental models evaluate confounding variables—
providing evidence that mediator effects are not due to confounders. 
 
MODEL FORMULATION. The underlying model is a mixed-effects latent growth curve model with repeated 
measurements (level-1) nested within youth/parents (level-2), implemented in Mplus (v7.31;197). As reviewed by 
MacKinnon,200 there are several options for modeling longitudinal mediation. Flexibility of growth models for 
targeting phase-specific change201 are leveraged and combined with parallel process models for mediation.202 
In a single model, there are separate change estimates for during- and post-treatment phases, directly 
addressing temporal sequencing of mediators and outcomes. The UDS outcome is modeled using a Bernoulli 
distribution, and remaining ultimate outcomes, direct targets, and indirect targets are modeled with normal 
distributions. Time terms are computed using assessment dates.203 Treatment condition is a youth/parent-level 
predictor (level-2; CM = 0, CM+ = 1), and cross-level interactions are specified between condition and level-1 
growth and phase terms. Models, as indicated, control for age, sex, race, ethnicity, SES, and treatment history. 
Likewise, preliminary models test, and control, for differences in outcomes across therapists and clinics. Follow-
up models determine whether individual paths and mediated effects differ for males and females. 
 
STATISTICAL TEST FOR MEDIATION. The test for mediation is based on the product of coefficients (i.e., αβ) with 
asymmetric bootstrapped SEs and 95% CIs for the product.204 This test requires estimation of two parameters 
and their SEs, where, for example, α is the effect of CM+ on parent management and β is the effect of parent 
management on substance use and externalizing behavior. Parameters are obtained from Mplus and supplied 
to PRODCLIN205 for the asymmetric boostrapped SEs and CIs. This approach offers enhanced statistical 
power206 and applies both to multilevel data207 and longitudinal mediation.200 
 
EVALUATION OF SPECIFIC AIMS 
 
AIM 1: DETERMINE WHETHER PARENT MANAGEMENT SKILLS (DIRECT TARGET) MEDIATE THE EFFECT OF 
TREATMENT ON YOUTH SUBSTANCE USE & BEHAVIOR PROBLEMS (ULTIMATE OUTCOMES). The test for mediation 
requires the coefficient and SE for CM+’s effect on parenting (a-path) and parent management’s effect 
(controlling for treatment) on substance use and externalizing behavior (b-path). Of note, a preliminary model 
evaluates the direct effect of CM+ on substance use and externalizing behavior (c-path), though as noted by 
MacKinnon,199 mediation should be tested regardless of this path’s significance. 
 
a-path. This model is specified with 11 repeated measurements of parenting as the outcome. To address 
temporal sequencing, the model estimates separate change rates for during- and post-treatment phases. This 
is tailored to each youth’s course of treatment using coding strategies for discontinuous (piecewise) change (see 
Singer and Willett201). Changes during treatment phase are modeled with linear and quadratic terms for number 
of months since baseline. A dichotomous phase indicator differentiates post- and during-treatment 
measurements, and post-treatment change is modeled as linear and quadratic terms for number of months since 
treatment end. This provides three estimates: during-treatment slope (estimate of interest for mediation test), 
overall shift in parenting levels from during- to post-treatment, and post-treatment slope. 
 
b-path. This model is more complex, simultaneously evaluating the mediator and outcome processes. To 
obtain this coefficient, the a-path is modeled along with the outcome model (c-path; testing for differences 
between CM+ and CM on substance use and externalizing behavior). With fewer outcome measurements, the 
model includes a during-treatment slope term and indicators to differentiate 9- and 12-month assessments, 
providing three estimates: during-treatment slope, change at 9 months, and change at 12 months. To obtain the 
b-path coefficient, a regression is specified with during-treatment mediator slope as a predictor of outcome at 9 
and 12 months. This provides a targeted test of mediation, with during-treatment change in the mediator as a 
predictor of post-treatment outcomes. 
 
Ethnicity effects. In close consultation with project consultant MacKinnon, and to address potential for 
differential effects across project clinics, formal moderated mediation tests can be performed.208-209 These tests 
determine whether observed mediation effects differ for Latino and non-Latino youth/parents. Sample size 
means that results are hypothesis-generating and thus will focus on estimation of confidence intervals. The same 
approach will be used to evaluate moderated mediation for ethnicity in Aims 2 and 3. 
 
Confounding variables. Although randomization, the enhancement mediation design, and models 
addressing temporal sequencing increase the likelihood of valid causal inferences for mediation, a remaining 
assumption is that there are no unmeasured confounding variables for the mediator’s effect. Cox et al.210 
recommends sensitivity analyses for confounder bias be used. First, VanderWeele’s211 formulas identify 
youth/parents with the same value on the mediator but different values on the outcome, as well as youth/parents 
with the same value on the mediator across both CM and CM+ groups. Second, residuals from the models just 
detailed should be uncorrelated, and Mplus code from Imai et al.212 is used to determine whether the mediated 
effect differs based on unmeasured pre-treatment variables. Third, Mauro’s213 correlational method evaluates 
the sources of error variance from the mediation model, determining how large the effect of an omitted variable 

would need to be to negate the mediated effect. 
 
AIM 2: DETERMINE WHETHER PARENT MANAGEMENT SKILLS (DIRECT TARGET) MEDIATE THE EFFECT OF 
TREATMENT ON YOUTH BEHAVIORAL REGULATION & DEVIANT PEER RELATIONS (INDIRECT TARGETS). In the parallel 
process model for Aim 2, the a-path is identical to that for Aim 1. The “outcome” model is nearly identical, the 
only difference being that the “outcomes” are indirect targets of treatment, behavioral regulation and peer 
relations. The b-path coefficient represents the association between the during-treatment slope for parent 
management and the 9- and 12-months post-treatment levels of behavioral regulation and peer relations. 
 
AIM 3: DETERMINE WHETHER BEHAVIORAL REGULATION & DEVIANT PEER RELATIONS (INDIRECT TARGETS) 
MEDIATE THE EFFECT OF PARENT MANAGEMENT SKILLS (DIRECT TARGET) ON YOUTH SUBSTANCE USE & BEHAVIOR 
PROBLEMS (ULTIMATE OUTCOMES). Aim 3 uses the same approach, with one key difference: rather than treatment 
condition, the initial variable is parent management (the direct target of treatment) and, as such, there are 
repeated measurements. The a-path represents the effect of parent management on behavioral regulation and 
deviant peer relations. With both measured longitudinally, this takes the form of the during-treatment slope for 
parent management predicting the during-treatment slope for behavioral regulation and deviant peer relations. 
Although this could confound timing and sequencing of a-path effects, the results of Aim 2 will have established 
the extent to which there is evidence supporting a causal association between the direct and indirect targets of 
treatment. The outcome model is identical to that for Aim 1. The b-path, holding constant the effect of parent 
management, is the effect of the during-treatment slopes for behavioral regulation and peer relations on the post-
treatment levels of substance use and behavior problems. 
 
STATISTICAL POWER FOR MEDIATED EFFECTS. The proposed mediation models include estimates of: (1) the 
effect of the initial variable on the hypothesized mediator (α-path), (2) the effect of the hypothesized mediator on 
the outcome (β-path), and (3) the mediated effect (αβ). Using Monte Carlo simulations implemented in Mplus,214-
215 power is determined by the percentage of replications with a significant effect for the path of interest. Using 
covariance algebra provided by Thoemmes et al.,215 parameters (path coefficients, variances, residuals) were 
tailored to reflect α- and β-paths with small-to-medium (R2 = .07) effects. For each model, sample size, 
conservatively assuming 10% attrition, was 155, with 10000 replications from the population. For a-path, power 
was >.90 to detect a small-to-medium effect of the initial variable on the mediator. For β-path, power was .85 to 
detect a small-to-medium effect of intermediate targets on ultimate outcomes. For the mediated effect, power 
was .83. This estimate is conservative due to the simulation’s Sobell SE method. As an upper bound on power, 
and based on simulations using the proposed asymmetric SE method, Fritz and MacKinnon216 found a sample 
of N=74 sufficient for .80 power to detect medium effects for α- and β-paths. 
ATTRITION AND MISSING DATA 
Participants will be retained in research measurement independent of CM/CM+ participation following intent-
to-treat principles.217 Along with this, the successful participant tracking and retention protocols used in OSLC 
research will minimize missing data. However, because some data will inevitably be missing, methods 
recommended by Schafer and Graham218 will evaluate assumptions and guide analyses. Three steps will be 
used: (1) For a small proportion of missing data with evidence of Missing at Random (MAR), data will be analyzed 
using the estimation procedures described above. (2) For a non-trivial amount of missing data and evidence of 
MAR, multiple imputation for repeated measurements will generate complete data.219 (3) For a non-random 
missing data mechanism, pattern mixture models will identify and control its effects.203–204 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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