Testing the Efficacy of Mindfulness-Based Stress Reduction Combined With Behavioral Parent Training in Families With Preschoolers With Developmental Delay
Phase: NA
Conditions: Development Delay, Behavior Problem
Sponsor: University of Oregon

Official Title: The PRO-Parenting Study: Helping Parents Reduce Behavior Problems in Preschool 
Children with Developmental Delay 
 
Brief Title: Partnerships in Research for Optimizing Parenting (PRO-Parenting Project) 
NCT Number: NCT03599648 
 
Document Type: Study Protocol and Statistical Analysis Plan 
Document Date: 10/17/2024 
 
 
 
 
 

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Research PlanResearch Plan
IMPORTANT: When completing this outline, please use the Research Plan Guidance for the content necessary to develop a 
comprehensive yet succinct Research Plan. Using the guidance to complete this outline will help facilitate timely IRB review.
Study Title:Study Title:
Testing the Efficacy of Mindfulness-Based Stress Reduction Combined with 
Behavioral Parent Training in Families with Preschoolers with Developmental Delay (aka the Pro-Parenting 
Project)
Protocol Number:Protocol Number: 03212018.023
Principal Investigator:Principal Investigator:
Laura Lee McIntyre 
A.
Introduction and Background
Behavior problems are a common and concerning challenge among children with developmental delays (DD).
Approximately 50% of children with DD have a comorbid mental disorder or serious behavior problems- a
prevalence three times as high as that found in typically developing youths. Behavioral parent training (BPT)
is the gold-standard intervention for treating child behavior problems in typically developing children and in
children with DD. However, high levels of parental stress are associated with reduced or no response to BPT
for children with DD. Consequently, parental stress may attenuate the efficacy of the gold-standard,
empirically supported treatment for behavior problems among children with DD. As such, parental stress is a
critical point of intervention for improving both parent and child outcomes in families of children with DD. The
purpose of this study is to quantify the therapeutic benefit of adding a parent stress-reduction intervention
prior to delivering BPT in order to more effectively reduce child behavior problems, and to investigate the
mechanisms through which intervention outcomes occur.
This study has significant potential to improve the long-term well-being of children with DD and their families
by determining the added benefit of targeting parenting stress and parent management strategies to more
effectively reduce behavior problems among children with DD. Findings from this study will improve the
scientific understanding of evidence-based interventions for behavior problems among children with DD and
the mechanisms underlying therapeutic change.
B.
Specific Aims/Study Objectives
Aim 1: Test the efficacy of BPT-M, which adds a parent stress-reduction intervention (MBSR), compared with
BPT-E (BPT+ psychoeducational control), for reducing the distal outcome of child behavior problems.
Hypothesis 1: Children of parents who complete the BPT-M intervention will exhibit greater and more
sustainable reductions in child behavior problems at posttreatment and at 6- and 12-month follow-up,
compared with children whose parents participate in the BPT-E intervention, as evidenced by parent and
teacher reports and observational measures of child behavior problems.
Aim 2: Examine if parenting behavior mediates the relation between intervention and child behavior
problems.
Hypothesis 2: Changes in parenting behavior, as measured by self-report and observations, will mediate the
relation between intervention and the reduction of child behavior problems at post-treatment and at 6- and
12-month follow-up.
Aim 3: Determine if the improvements in parenting behavior are, in turn, mediated by reductions in 
parenting stress, a proximal target of the BPT-M intervention.
Hypothesis 3: Improvements in parenting behavior will be mediated by a reduction of parenting stress 
immediately post-treatment and at 6- and 12-month follow up.
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C.
Methods, Materials and Analysis
Data for this research study will be collected at two sites, the University of Oregon Prevention Science Institute in 
Portland, OR, and Loma Linda University in Loma Linda, CA. Approximately 1/3 of the sample will be recruited 
and assessed by the UO site. The UO site will be responsible for all data management and but will not receive any 
some protected health information (PHI) from the Loma Linda site in order to recruit participants for Cohort 5. For 
example, names, addresses, birthdays, and medical histories previously collected by Loma Linda research staff 
when potential participants were added to a waitlist will not be shared with the Oregon site. The data sharing 
agreement between the two institutions has been modified to allow this sharing of information.
Methods for recruitment, baseline data collection, and parent groups will differ in this study between cohorts 1 and 
2 due to the COVID-19 pandemic and the increased physical distancing required to limit spread of the virus. 
Cohort 1 began with in-person data collection in homes and in-person parent groups. Cohort 1 was in the middle 
of parent groups when the “stay at home” orders were issued; groups then shifted to a remote/ Zoom format, as 
did all subsequent data collection. In contrast, all phases of the research project (baseline data collection, parent 
groups, follow-up data collection) will be conducted remotely for Cohort 2 (and additional cohorts, if any). There is 
only one exception to this: if/ when it is deemed safe by the University/ State of Oregon for us to meet in person 
with preschoolers who are not wearing masks, we will conduct the ADOS and Stanford-Binet tests in person 
(these tests are part of the “lab visit” described below). If current restrictions are not lifted by the end of the study 
period, we will simply forgo collection of the ADOS and Stanford-Binet.  
Because methods for recruitment, baseline data collection, parent groups, and immediate follow-up data collection 
differed between cohorts, descriptions of these methods are provided separately for each cohort. The methods 
described for lab visits, teacher data, and 6- and 12-month follow-up data collection apply to both cohorts and are 
labeled as such.
Data from other cohorts were collected at Loma Linda University using protocols and documents approved by 
their IRB. Moving forward, the University of Oregon research team has been asked to help the Loma Linda team 
recruit participants living in California for Cohort 5 and help collect some data components. University of Oregon 
research team members have been added to the research team included in the protocol at Loma Linda University 
and will follow the LLU IRB-approved protocols and use the LLU IRB-approved documents when working with 
participants residing in California. However, University of Oregon team members will continue to use UO IRB-
approved protocols and documents when working with participants residing in Oregon. Loma Linda research staff 
will have no contact with participants living in Oregon nor their identifiable information.
Recruitment and Baseline Data Collection
Cohort 1
Recruitment methods are described below in section D. Interested parents will either contact the PRO-Parenting 
Project by phone or by completing a form on our project website. If the family indicates interest in participation, 
trained staff will conduct a phone screen (“Script for initial contact phone screen” and “PRO-Parenting clinical 
phone screen form”). If the family meets eligibility for the study, an appointment will be scheduled for the initial 
home assessment (“script for confirmation call to schedule home visit”). Information gathered from the screening 
calls will be destroyed for families who do not meet eligibility requirements, as well as for those who do meet 
requirements but choose not to participate. For families who proceed to the study, information gathered from the 
screening call will be used to assess parenting stress, which is a variable of interest to this study. 
As the name implies, the initial home assessment will take place in participants’ homes. Prior to the initial home 
assessment, parents will be mailed a packet of questionnaires (“PP-T1 mailout-PC”) that they will complete before 
the assessors go to the home visit. At the initial assessment, parents will be given a consent form and research 
staff will review this document with the parent (informed consent process is described below in section E). Parents 
who do not agree to be videotaped for the study will still be allowed to participate in the study. After completing the 
consent process, the parent and the child will participate in a 20-minute videotaped play assessment in the home. 
Parent and child will be given a standardized set of toys and asked to complete 4 tasks: (1) Unstructured free play 
task (parent is instructed to allow the child to choose any activity and play along with the child as they normally 
would); (2) Clean-up task (parent is instructed to give the child a command to clean up); and (3) Parent teaching 
task (parent is instructed to select an activity and to keep the child playing according to the parent’s rules); (4) 
Child Frustration Task (child is given a difficult task and asked to complete quickly to earn a prize). We will use 
established coding systems to evaluate parent and child behavior in these tasks (Simple Affect Code: Jabson & 
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Dishion, 2004; Relationship Process Code: Jabson & Dishion, 2005; Parent-Child Behavior Observation System: 
Phaneuf & McIntyre, 2007). After the observation task with the child, parents will meet with an assessor to 
complete the parent demographic form and the service utilization form (found in “PP-T1_inhome”) and the Change 
Plan Worksheet (see “BPT-E PEI form” and “BPT-M PEI form”; these forms are very similar but one is for 
participants in the BPT-E condition and one for those in the BPT-M condition). The initial home visit should take 
60-90 minutes to complete. After the visit is over and research staff return to the office, staff members will 
complete the Visit Impressions form (see “Updated VIMP-1.17.2020-pp1vimp”). 
Prior to the baseline assessment, parents will be randomly assigned by the Data Manager to either the behavioral 
parent training group with a mindfulness component (BPT-M) or an education component (BPT-E) by means of a 
random numbers table. An approximately equal distribution of families will be assigned to each of the two 
conditions. Families will be told of their condition assignment at the end of the observation task in the baseline 
visit. 
Cohort 2
Recruitment methods are described below in section D. Interested parents will either contact the PRO-Parenting 
Project by phone or by completing a form on our project website. If the family indicates interest in participation, 
trained staff will conduct a phone screen (“Cohort 2 Script for initial contact phone screen” and “Cohort 2 script 
clinical screen baseline”). If the family meets eligibility for the study, they will be mailed an assessment packet, 
consent form, and return envelope, and will be scheduled for a series of 3 remote appointments for the purposes 
of baseline data collection (“Cohort 2 script for confirmation call to schedule remote home visit”).  Information 
gathered from the initial screening calls will be destroyed for families who do not meet eligibility requirements, as 
well as for those who do meet requirements but choose not to participate. For families who proceed to the study, 
information gathered from the screening call will be used to assess parenting stress, which is a variable of interest 
to this study. 
Baseline data collection for this study will be collected via a packet of questionnaires mailed to participants’ homes   
(“PP-T1 mailout-PC”) and a series of 3 appointments conducted via Zoom. Parents will complete questionnaires 
prior to the first of the 3 appointments and mail them back to project staff as soon as possible (see “c2 cover letter 
baseline survey packet” and “Oregon PRO-Parenting study KIT Form”). The first appointment will be between the 
parent and a research assistant and conducted over Zoom (see “C2 Baseline DEM-Serv Script Zoom#1”). At this 
appointment, research staff will complete consent procedures (informed consent process is described below in 
section E), the parent demographic form and the service utilization form (found in “PP-T1_inhome”), and provide 
preliminary instructions for the family observation tasks that will occur in appointment 2 (see “virtual play task 
instructions #1 sent with survey”). The research assistant will also trouble-shoot any sort of technology- or 
materials-related issues at this appointment to make sure that the parent is prepared for the family observation 
task. 
Prior to the second Zoom appointment, parents will receive a box of assessment materials in the mail intended to 
help facilitate the family observation task (see “c2 cover letter_baseline assessment kit” and “virtual play tasks 
instructions #2 sent in kit”). This box will include 3 puzzles and a play mat that will be used for the home visit; 
families may keep these items and add them to their child’s toy collection after the visit. The second Zoom 
appointment will involve a research assistant, the parent, and the target child. The purpose of the second 
appointment is to record the family observation task, a 20-minute videotaped play assessment between the parent 
and target child. At the beginning of this appointment research staff will go over the remaining instructions for the 
family observation task. The parent and child will then be asked to complete 3 tasks (see “C2 baseline play task 
script protocol”): (1) Unstructured free play task (parent is instructed to allow the child to choose any activity and 
play along with the child as they normally would); (2) Clean-up task (parent is instructed to give the child a 
command to clean up); and (3) Parent teaching task (parent is instructed to select an activity and to keep the child 
playing according to the parent’s rules). We will use established coding systems to evaluate parent and child 
behavior in these tasks (Simple Affect Code: Jabson & Dishion, 2004; Relationship Process Code: Jabson & 
Dishion, 2005; Parent-Child Behavior Observation System: Phaneuf & McIntyre, 2007). 
The third Zoom appointment is a rapport building appointment between the family interventionist and the parent 
and will be conducted via Zoom. At this appointment, the parent and family interventionist will complete the 
Change Plan Worksheet (see “BPT-E Change Plan Worksheet PEI baseline” and “BPT-M Change Plan 
Worksheet PEI baseline”; these forms are very similar but one is for participants in the BPT-E condition and one 
for those in the BPT-M condition).  The family interventionist will also complete a Qualtrics COVID survey as an 
interview (see “Impact of covid-19 survey for qualtrics”) during this appointment to gather additional information 
about family stressors during this unique historical period.  See “c2 PEI BPT-M Protocol script” for script for this 
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visit for participants assigned to the BPT-M group and “c2 PEI BPT-E protocol script” for participants assigned to 
the BPT-E group.
Prior to the baseline assessment, parents will be randomly assigned by the Data Manager to either the behavioral 
parent training group with a mindfulness component (BPT-M) or an education component (BPT-E) by means of a 
random numbers table. An approximately equal distribution of families will be assigned to each of the two 
conditions. Families will be told of their condition assignment at the end of the observation task in the baseline 
visit. 
Parent Groups
Cohort 1
For our first cohort, two parent groups were run concurrently and face-to-face at King School in Oregon City, OR 
(this facility is a former elementary school managed by the Clackamas ESD for HeadStart classes and early 
childhood special education classes) until the COVID-19 pandemic forced the CESD to close the building on 
March 12, 2020. Prior to the building closure, childcare was offered during all sessions and provided by staff who 
worked at the ESD, who had experience working with children with DD, and who were willing to work for our 
project as a paid second job. After the building closure, the two parent groups for Cohort 1 were run as virtual 
meetings through the Zoom platform, and no childcare was provided.
Cohort 2
For our second cohort (and any later cohorts), the two parent groups will be run 100% as virtual meetings through 
the Zoom platform and no childcare will be provided. All materials required for participation in parent groups will 
be mailed to parents prior to the first session.
Both Cohorts
The BPT-M group and the BPT-E groups will be led by staff with a minimum of a Masters-level education in 
clinical or counseling psychology or social work. These individuals will be trained and supervised by a doctoral-
level licensed psychologist. Parents randomly assigned to the BPT-M group will receive six sessions of 
Mindfulness-Based Stress Reduction followed by the 10-week BPT intervention described below. The MBSR 
component of the BPT-M intervention will include six weekly 2-hour group sessions and 30–45 minutes of daily 
home practice guided by instructional audio CDs and an MBSR parent workbook (see “Baer Mindfulness Home 
Practice Log” for sample homework for the Mindfulness group). Formal mindfulness exercises aim to increase the 
capacity for mindfulness (present moment awareness with a compassionate, nonjudgmental stance) and include a 
body scan, mindful yoga, and sitting meditation. In the sessions, participants practice formal mindfulness 
exercises and ask questions relating to the practice of mindfulness in everyday life, and the instructor provides 
didactic instruction on stress physiology and using mindfulness for coping with stress in daily life. 
Parents randomly assigned to the BPT-E group will receive six sessions of education about children with 
developmental delays. The BPT-E group will also consist of 6-weekly 2-hour education sessions where families 
will gain information regarding their child's development, disability, and associated considerations. Each week has 
a general topic for discussion. Topics include Preparing for Individualized Education Plan (IEP) meetings, 
Navigating regional service agencies, communicating with Teachers, Advocacy, Sibling Issues, and Community 
Resources. At the start of each session, group leaders provide some didactic material on the topic. Parents then 
break up into pairs for small group discussion (via “breakout rooms” when groups conducted via Zoom) followed 
by a larger group discussion and questions. Parents in this group will also receive homework each week (see 
“BPT-E Hand Out Session 2”). Following the 6-week educational intervention, families will receive the same 10-
week Behavioral Parent Training intervention described below.
All participants will then receive the Incredible Years Parent Training-Developmental Disabilities modified 
intervention. The IYPT-DD intervention is 10 weeks in duration, with each weekly session lasting 2 hours. Each 
weekly session is structured around videotape vignettes and uses discussion, role-playing, modeling, and 
feedback techniques to create an effective learning environment for the parenting skills that are taught. Topics 
include: using developmentally appropriate play to engage children, using praise and rewards to encourage 
children’s development, and using effective behavior management strategies to reduce challenging behavior. 
Parents are given weekly homework assignments and have the opportunity to practice their skills both inside and 
outside of intervention sessions (see “Hand Out BPT Session 1 Play Time”).
All participants, regardless of treatment condition, will complete a brief Subjective Units of Distress Scale (SUDS; 
see “PP-PDX-tx-SUDS”) at the beginning of each session and a weekly evaluation form at the end of each 
session (see “PP-PDX-tx-PWE-s1-6” and “PP-PDX-tx-PWE-s7-16”). For Cohort 1, these forms were collected via 
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Teleform surveys when groups met face-to-face. Once parent groups shifted to a virtual format, these forms were 
collected via Qualtrics. These forms will continue to be collected via Qualtrics in Cohort 2 and future cohorts. 
Participants will also complete a survey packet at the end of week 6 (see “PP-PDX-tx-PSI4”, “PP-PDX-tx-FFMQ”, 
and “PP-PDX-tx-GROUPQuestionnaire”), and at the end of week 16 during group time (see “PP-PDX-tx-PSI4”, 
“PP-PDX-tx-FFMQ,”  “PP-PDX-tx-PCBC,” “PP-PDX-tx-GROUPQuestionnaire,” “PP-PDX-tx-PPSQ-E” and “PP-
PDX-tx-PPSQ-M”; note the last two are very similar packets but one is for the BPT-M group and one is for the 
BPT-E group). During week 16, participants will also complete a brief telehealth satisfaction survey (see 
“Telehealth questions_final_6.4.2020”) via Qualtrics to assess their satisfaction with the parent groups/ 
interactions with group leaders after the transition to a remote format as a result of the COVID-19 pandemic. This 
questionnaire was slightly modified for cohort 2 to reflect the fact that this cohort did not transition to a remote 
format but instead did the entire intervention in a remote format (see “Telehealth questions_c2w2”).
In addition, research staff will collect data about parents during each parent group via the Group Attendance and 
Homework Completion Checklist (see “PP-PDX-tx-ATTN”) and Group Leader Ratings of Engagement/ Disruption 
(see “PP-PDX-tx-GLR-AC”).
Throughout the intervention, group leaders will have weekly phone check-ins with parents. During the check-in 
prior to the week 7 and week 16 groups, group leaders will collect additional data using the Change Plan 
Worksheet that was completed during the initial home visit (described earlier; see “BPT-E PEI form” and “BPT-M 
PEI form”).
Immediate Follow-up Data Collection
Cohort 1
After the completion of the intervention, parents will be asked to schedule a follow-up (virtual) home assessment. 
The same set of questionnaires used at the initial home visit will be mailed to the home to be completed prior to 
the home visit (see “PP-t1-mailout-PC”). Due to the physical distancing required by the COVID-19 pandemic, the 
post-intervention home visit will be conducted remotely and broken into two appointments: a phone appointment 
and a virtual home visit. Prior to the phone appointment, parents will receive a box of assessment materials in the 
mail intended to help facilitate the later virtual home visit. This box will include a cover letter, parent instructions, 
three puzzles, and a play mat (see “Assessment Kit Cover Letter_6.4.2020” and “Virtual Play Task Instructions-
Parents_6.4.2020”). They will then complete a 45-minute phone appointment in which the assessor goes over the 
previously signed consent form, collects the DEMO and SERV via interview with the primary caregiver, collects a 
12-item survey regarding the impact of the COVID-19 pandemic on their family, and then explains the logistics of 
the virtual home visit to parents using the instructions provided to parents in their box of materials (see “Demo-
Serv Interview Protocol_6.19.2020” and “Impact of COVID19 Measure_6.12.2020”; note that the DEMO and 
SERV were originally part of the in-home packet completed during home visits and can be found in “PP-
T1_inhome”). During the virtual home visit, the parent and child will complete 3 of the 4 play tasks completed at 
baseline: (1) Unstructured free play task (parent is instructed to allow the child to choose any activity and play 
along with the child as they normally would); (2) Clean-up task (parent is instructed to give the child a command to 
clean up); and (3) Parent teaching task (parent is instructed to select an activity and to keep the child playing 
according to the parent’s rules). Virtual home visits will be scheduled for 30 minutes, but these play tasks should 
take a total of 15 minutes to complete (see “Post Treatment Virtual Obs Protocol_6.19.2020”).
Cohort 2
After the completion of the intervention, parents will be asked to schedule a follow-up (virtual) home assessment. 
The same set of questionnaires used at the initial home visit will be mailed to the home to be completed prior to 
the home visit (see “PP-t1-mailout-PC”). Parents will also receive a link to Qualtrics to complete a brief survey 
about the impact of the covid-19 pandemic on their family (see “Impact of covid-19 survey for qualtrics”). The post-
intervention home visit will be conducted remotely and broken into two Zoom appointments. Prior to the first Zoom 
appointment, parents will receive a box of assessment materials in the mail intended to help facilitate the later 
virtual home visit. This box will include a cover letter, parent instructions, three puzzles, and a play mat (see 
“Cover Letter Assessment Kit_c2w2” and “Virtual Play Task Instructions-c2w2”). They will then complete a 45-
minute Zoom appointment in which the assessor goes over the previously signed consent form, collects the 
DEMO and SERV via interview with the primary caregiver, and then explains the logistics of the virtual home visit 
to parents using the instructions provided to parents in their box of materials (see “Demo-Serv Interview 
Protocol_6.19.2020.” Note that the DEMO and SERV were originally part of the in-home packet completed during 
home visits and can be found in “PP-T1_inhome”). During the virtual home visit, the parent and child will complete 
the 3 play tasks completed at baseline: (1) Unstructured free play task (parent is instructed to allow the child to 
choose any activity and play along with the child as they normally would); (2) Clean-up task (parent is instructed to 
give the child a command to clean up); and (3) Parent teaching task (parent is instructed to select an activity and 
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to keep the child playing according to the parent’s rules). Virtual home visits will be scheduled for 30 minutes, but 
these play tasks should take a total of 15 minutes to complete (see “Play Obs Task Script/ Protocol_c2w2”).
6-month and 12-month Follow-up Data Collection
Both Cohorts
Six months and twelve months after the groups have finished, there will also be phone appointments and virtual 
home visits to collect the 6-month and 12-month follow-up assessments. At these assessments, the parents will 
again be mailed the same packet of questionnaires used at prior waves of data collection and asked to complete it 
prior to the virtual home visit. They will again participate in a 45-minute phone or Zoom appointment and a 30-
minute virtual home visit in order to complete the 3 play activities. In addition, a link to a Qualtrics survey regarding 
the impact of the covid-19 pandemic on their family will be sent to parents at the same time as the 6- and 12-
month follow-up survey packets (See “Impact of covid-19 survey for qualtrics_rev2”). 
 “Lab Assessment”
There will be a “lab assessment” for the developmental evaluation of the child; this lab visit was originally intended 
to occur face-to-face at either the PSI lab in Portland, OR, located at the University of Oregon-Portland campus or 
in an empty classroom at the King School in Oregon City, OR, but was modified due to the physical distancing 
restrictions of the COVID-19 pandemic. This “lab assessment” can be scheduled to take place at any point during 
the study, but is intended to occur close in time to the pre-intervention assessment. The original plan for the lab 
visit was for the child to complete the Autism Diagnostic Observation Schedule-2 (ADOS-2; Lord et al., 2012) and 
the Stanford-Binet Intelligence Scales (SB%; Roid, 2003) with a trained master’s level (or above) research 
assistant. The ADOS-2 is a semi-structured assessment that facilitates observation and recording of child 
behaviors related to language, social communication and interaction, play, and repetitive behaviors and restricted 
interests. The results would be used to examine the contribution of autism spectrum disorder symptomology to 
intervention outcomes. The Stanford-Binet Intelligence Scales, Fifth Edition (SB5; Roid, 2003) would be 
administered to estimate children’s general cognitive functioning. Dr. McIntyre would oversee training and 
supervision of the ADOS-2 and Stanford-Binet administration, scoring, and interpretation for this project.. In 
addition,  the Vineland Adaptive Behavior Scales-III (VABS-III; Sparrow, Cicchetti, & Saulnie, 2016) would be 
used to characterize children’s level of independence in the everyday environment. Scores on the VABS-III would 
be used to assess the presence of comorbid intellectual disability. During the child’s lab assessment, the 
participating parent would complete the Social Communication Questionnaire, Lifetime Version (SCQ; Rutter, 
Bailey, & Lord, 2003) to inform diagnostic confirmation. Overall, the lab assessment would take about an hour to 
complete (forms for these three assessments can be found in “PP-T1_inhome”). However, because of the 
physical distancing required by COVID-19, we chose to break these “lab visits” into two visits: (1) a phone 
appointment with the parent, and (2) a face-to-face assessment with the child, assuming it is eventually safe to do 
face-to-face visits without masks in the future.  For the phone appointment, we will collect the VABS-III via 
telephone interview with the parent. The SCQ will be added to the mail-home baseline assessment packet and 
completed by the parent as part of the questionnaire packet. The face-to-face assessment with the child will be 
put on hold until the IRB determines that it is again safe to do face-to-face data collection without masks. At that 
time, the ADOS-2 and SB5 will be completed with each child. If current physical distancing and masking 
restrictions are not lifted by the end of the study period, we will simply forgo collection of the ADOS and Stanford-
Binet.  
Teacher Data
At the time of the baseline assessment, parents will consent to allowing the research team to contact teachers to 
request information about their child. Each school year parents will be asked to provide research staff with the 
name, email address, and mailing address of their child’s teacher. We will then email an introduction letter and a 
copy of the teacher consent form to the teacher (see “PP Teacher Email_6.23.2020FINAL” and 
“PROParenting_teacher consent_11.12.19”). Once the teacher returns their electronically-signed consent form via 
email, they will receive a second email with a link to a Qualtrics questionnaire about the child’s behavior (see 
“PRO P Teacher Survey Link Email 6.23.20,” “PRO-parenting teacher demo,” and “PP-t1_teacher”). A copy of the 
parent’s consent form will be emailed to the teacher upon request. Teacher contact information will be collected 
from the parent at four time points: before the intervention, at the end of the intervention, and at 6 months and 12 
months after the intervention is completed. The Qualtrics teacher survey should take no longer than 20 minutes to 
complete. The duration of teacher participation in the project will depend upon how long the target child is in a 
given teacher’s class. We will be collecting information from teachers up to 18 months from baseline, but this will 
most likely involve two or more teachers as children tend to transition to new classrooms/ teachers each school 
year.
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COVID-19 Interview
In order to make sure that our intervention remains relevant to families during the COVID-19 pandemic, we will be 
collecting additional information regarding families' experiences with COVID-19, social distancing, additional 
stressors they are experiencing, and the impact of possible reductions in services they were previously receiving.
 
For Cohort 1, these data were initially collected via a phone interview lasting approximately 1 hour (see COVID-19 
interview questions for PROParenting families_FINAL” and “COVID-19 survey questions for PROParenting 
families_4.14.20_Final”) as a separate data collection activity in Spring 2020. Longitudinal data will be collected 
from this cohort via Qualtrics survey in Fall 2020 and at the time of 6-month and 12-month follow-up data 
collection as described above (see “impact of covid-19 survey for Qualtrics”). The Covid-19 survey collected at the 
12-month follow-up will be slightly modified from the one given at earlier time points to have tighter time frames on 
questions (see “impact of Covid-19 survey for Qualtrics_rev2”).
For Cohort 2, these data will be collected via Qualtrics survey at baseline and immediate follow-up data collection, 
as described above. At baseline, the completion of this Qualtrics survey will be facilitated by the family 
interventionist in an interview-format during the rapport building appointment; participants will complete it on their 
own at the time of immediate follow-up (see “impact of covid-19 survey for Qualtrics_rev2”).
Data Analysis
Analyses will be conducted using standard normal theory regression and structural equation modeling (SEM) 
techniques, with a particular focus on latent growth modeling (LGM; Muthén & Curran, 1997). To isolate the added 
value of the MBSR component of the BPT-M intervention, primary intent-to-treat (ITT) efficacy hypotheses 
comparing the BPT-M with BPTE will be specified within a set of sequential mediation analyses (DeGarmo, 
Patterson, & Forgatch, 2004). We will use CACE modeling (Jo, 2002; Little & Yau, 1998) for analyzing and 
adjusting effect sizes on the basis of participant compliance and dosage in both groups. CACE mixture models 
allow unbiased estimates of intervention contrasts by modeling unknown compliance status as missing data using 
the known compliance in the intervention of focus, thereby matching latent characteristics to the two group 
conditions. We will intentionally assess and control for potential confounding variables that pose a possible threat 
to the internal validity of the study, namely, child diagnosis (e.g., ASD), child IQ/intellectual disability status, child 
gender, concurrent child services, and demographic variables (e.g., ethnicity, family language, family structure, 
SES).
For the primary main effects efficacy evaluation, BPT-M versus BPT-E, we will specify LGMs. For our primary 
intervention efficacy hypotheses, child outcomes are considered distal because they are not the primary active 
agent of intervention. Any BPT intervention effects on children are hypothesized to operate through, and be 
transmitted through, more-proximal mechanisms of reduced parenting stress, and in turn, improved parenting 
(Forehand, Lafko, Parent, & Burt, 2014). For growth outcomes, a sequential set of models tests the latent 
variances and model fit comparing a random intercept only versus linear growth or quadratic growth models to 
determine the optimal pattern of change (Duncan, Duncan, & Stryker, 2006). For example, we will test the 
hypothesis that the BPT-M will show greater 1-year reductions in child behavior problems relative to the BPT-E 
condition. This effect is hypothesized to be mediated first by improvements in effective parenting behaviors. 
Intervention impact on growth in positive parenting skills, in turn, is hypothesized to be mediated by reductions in 
parenting stress, the target of the E-BPT intervention.
For tests of mediation, we will use approaches outlined for SEM and LGM (Cheong, MacKinnon, & Khoo, 2001; 
Judd, Kenny, & McClelland, 2001; Kraemer, Wilson, Fairburn, & Agras, 2002; MacKinnon & Luecken, 2008), 
including tests of indirect effects following recommendations using bootstrapped standard errors for the 
asymptotically distributed multiplicative indirect terms and estimated bias-corrected confidence intervals 
(MacKinnon, Fairchild, & Fritz, 2007; Preacher & Hayes, 2008).
D. Research Population & Recruitment Methods
1. Participant Population:
Between the Oregon and California sites, we anticipate screening 300 families to recruit 230 children with DD 
and their families (n=150 in CA; n=80 in OR). This would result in roughly 115 participants in each of the 
treatment conditions, which will provide adequate statistical power to minimally detect modest to medium 
effects in our primary analyses. These effect sizes are conservative based on past research.
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Participation will be limited to parents of children ages 3 to 5 who are English-speaking. The rationale for the 
age restriction is that parents of children often exhibit heightened stress during the preschool years, while 
simultaneously experiencing a reduction in services because Early Intervention services in Oregon terminate 
when the child is 3 years of age. All parents must speak and understand English because the clinicians who 
will be delivering the intervention are all English speaking.
Inclusion Criteria:
•
Having a child ages 3 to 5 years with an agency-identified DD in one or more functional areas who is 
receiving early intervention or early childhood/ preschool special education through an individualized 
family service plan (IFSP) or individualized education plan (IEP);
•
Elevated parent-reported child behavior problems, as indicated by a T-score of 60 or above on the 
Total Problems scale of the child Behavior checklist;
•
Elevated parenting stress, as indexed by a total score above the recommended cutoff at the 85th 
percentile on the Parenting Stress Index-4.
•
Access to internet/ Zoom to complete online intervention and assessments during the study period.
Exclusion Criteria:
•
Parents will be excluded if they screen positive for active psychosis, substance abuse, or suicidality 
through endorsement of screening questions for associated modules of the Structured Clinical 
Interview for DSM Disorders (SCID)-Research Version Non-Patient Edition;
•
They are currently receiving any form of psychological or behavioral treatment at the time of referral 
(e.g., counseling, parent training, parent support group); 
•
The parent or child does not speak or understand English; or 
•
The child has sensory impairments (e.g., deafness, blindness,) or nonambulatory conditions that 
would necessitate the need for significant modifications to the lab and home visit protocols
Please note that lack of access to the internet/ Zoom is not an exclusionary criterion for this study. The PRO-
Parenting Study is inviting every family who is interested to reach out to them. Our family interventionists will 
work with families to connect with community resources and existing supports to access the internet or 
acquire needed technology. 
The child is only involved in the assessment aspects of the study pre-intervention, post-intervention, and at 
follow-up. During these assessments the child is instructed to play on the floor with the parent for 20 
minutes. This task requires the child to understand the researcher’s directions, sit up on his or her own, 
explore different toys in the room, and interact with the parent. Therefore, if the child has a physical disability 
or sensory impairment that prevents him or her from participating in the play task, the family will be excluded 
from the study.
The sample will also include the teachers of each of the target children. “Teacher” will be defined as any 
professional that works directly with the child who would be able to report on behavior. If a child is not in 
school, this person may be a behavioral therapist or other service provider who works with the child. 
Babysitters who regularly care for the child and are able to accurately report on the child’s behavior would 
also be allowed if there are no other options. A teacher will be identified at baseline, at the end of the 
intervention, and at 6 and 12 months post-treatment. These assessment points will span a total of 18 
months, and children are likely to transition between teachers/ classrooms during this time frame. Thus, it is 
likely that different teachers will report on a given child’s behavior across the span of the study. We anticipate 
that the final sample may include up to 500 teachers (150 in OR).
2. Recruitment Methods:
In order to reduce the burden on ESD staff during the COVID-19 pandemic, we altered our recruitment methods 
between Cohort 1 and Cohort 2.  The two methods are described below and organized according to Cohort.
Cohort 1 
Families at the Oregon site will be recruited through the Clackamas ESD. Families who meet the study criteria will 
be identified from this agency’s computerized databases, and screened by agency staff. In order to protect 
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confidentiality, letters and brochures about the project will be sent to prospective families by the staff of the 
Clackamas ESD, informing parents about our project (“Recruitment letter_11.12.2019”; “Oregon Copy of PRO-
Parenting Brochure_11.12.2019”). Interested parents will either contact the PRO-Parenting Project by phone or 
by completing a form on our project website: www.oregonproparenting.org . If the family indicates interest in 
participation, research staff will conduct a phone screen (“Script for initial contact phone screen” and “PRO-
Parenting clinical phone screen form”). If the family meets eligibility for the study, an appointment will be 
scheduled for the initial home assessment. Informed consent will be sought by research staff at the intake 
interview. In addition, consent will be sought to conduct the home-based videotaped caregiver-child interactions 
and to conduct lab assessments of child functioning.
To recruit teachers for the study, parents will be asked on their consent form to provide the name and contact 
information of a teacher or other professional who works directly with the child and would be able to report on 
the child’s behavior. The research team will then email consent forms and send electronic links to assessment 
materials (see details above in “method, materials, and analysis” section).The cover letter included with the 
consent form will contain contact information for project staff who can answer any questions about the study. 
Cohort 2 
Families at the Oregon site will be recruited through the Clackamas ESD and by flyers to be used with other 
agencies and community programs that serve this population (see “PRO-Parenting Flyer Final Draft”). The 
Clackamas ESD regularly sends out an email newsletter, and they have agreed to include a blurb about our study 
and a link to our website in several of these newsletters so that interested families can reach out to learn more 
(see ”recruitment blurb_cohort 2”). Interested parents will either contact the PRO-Parenting Project by phone or 
by completing a form on our project website: www.oregonproparenting.org . The website includes a similar level 
of information as the flyer, but also includes a FAQ section and a short “welcome” video intended to give 
potential participants a better sense of what parent groups would be like (see “Intro Script for PRO-P_final”). If 
the family indicates interest in participation, research staff will conduct a phone screen (“Cohort 2 Script for initial 
contact phone screen” and “Cohort 2 script clinical screen baseline”). If the family meets eligibility for the study, a 
series of 3 appointments will be scheduled to complete the baseline assessment (“cohort 2 script for confirmation 
call to schedule remote home visit”). Verbal informed consent will be sought by research staff at the first of these 
3 appointments and a paper consent form will be included in the assessment packet mailed to the family’s home. 
In addition, consent will be sought to conduct the lab assessment of child functioning.
To recruit teachers for the study, parents will be asked at their first phone appointment to provide the name and 
contact information of a teacher or other professional who works directly with the child and would be able to 
report on the child’s behavior. The research team will then email consent forms and send electronic links to 
assessment materials (see details above in “method, materials, and analysis” section).The cover letter included 
with the consent form will contain contact information for project staff who can answer any questions about the 
study. 
3. Compensation/ Reimbursement:
Because the assessment strategy changed between the beginning of cohort 1 and cohort 2, the compensation 
structure was also altered between the 2 cohorts. The two methods are described below and organized according 
to cohort. Payment was increased for cohort 1 because of the addition of 4 waves of covid-related data collection 
and the unanticipated need to split the “lab visit” into 2 visits because of our inability to see children face-to-face 
during the pandemic.
Parents in cohort 2 are aware at the time of initial consent that the lab visit will be split into 2 visits, and thus we 
don’t feel the need to pay them double for this data collection. Covid-related data collection will only occur 2x for 
this cohort (compared to 4x for cohort 1), and thus their total payment is lower.  
Cohort 1
To compensate families for their participation and to keep attrition to a minimum, we will offer subject 
payment to families. Families will be reimbursed, via check, following the completion of the initial home visit 
($50), baseline lab assessment ($50 for the phone interview with parents; $50 for the portion conducted 
face-to-face with children), post-intervention ($75), 6-month follow-up ($100), and 12-month follow-up 
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($125). The amount increases as the study progresses, reflecting the increased value of longitudinal 
participation over time. In addition, participants will be offered bus passes or parking vouchers to alleviate 
transportation costs and facilitate their completion of the lab assessment or attendance at group sessions 
when groups meet face-to-face. Families will also be offered free childcare or a childcare stipend in order to 
facilitate their attendance at group sessions when groups meet face-to-face. This childcare will be provided 
by staff who work at the ESD, who have experience working with children with DD, and who are willing to 
work for our project as a paid second job. If the family withdraws from the study before completion, they will 
not receive the remaining payments. In the event that a visit needs to be rescheduled, the family will be 
compensated upon completion of the rescheduled visit.
Families will also be paid $25 via check for completion of the COVID-19 related data collection at each of 4 
time points (Spring 2020, Fall 2020, 6-month follow-up, and 12-month follow-up).
In total, families in cohort 1 can earn up to $550 for participation across their time in the study.
Teachers will receive a $25 check for completion of each of the four teacher assessments (pre-intervention, 
post-intervention, 6-month follow-up, and 12-month follow-up).
Cohort 2
To compensate families for their participation and to keep attrition to a minimum, we will offer subject 
payment to families. Families will be reimbursed, via check, following the completion of the baseline home 
visit ($50), baseline lab assessment ($25 for the phone interview with parents; $25 for the portion conducted 
face-to-face with children), post-intervention immediate follow-up ($75), 6-month follow-up ($100), and 12-
month follow-up ($125). The amount increases as the study progresses, reflecting the increased value of 
longitudinal participation over time. If the family withdraws from the study before completion, they will not 
receive the remaining payments. In the event that a visit needs to be rescheduled, the family will be 
compensated upon completion of the rescheduled visit.
Families will also be paid $25 via check for completion of COVID-19 related data collection at each of 2 time 
points (baseline data collection and post-intervention immediate follow-up).
In total, families in cohort 2 can earn up to $450 for participation across their time in the study.
Teachers will receive a $25 check for completion of each of the four teacher assessments (pre-intervention, 
post-intervention, 6-month follow-up, and 12-month follow-up).
 E. Informed Consent Process
We will be using information obtained during the phone screening and prior to obtaining parental consent for 
the study. Thus, we request an alteration of informed consent. This alteration does not involve more than 
minimal risk to the participants, and will not adversely affect the rights and welfare of the participants. The 
research could not be practicably carried out without the alteration. Participants will be provided with 
additional pertinent information at the time of informed consent, and will be provided with a method to 
indicate their consent to their screening information being used in the study (i.e., a separate line to initial to 
indicate use of these data).
Cohort 1
Informed consent will be obtained at the first home visit (pre-intervention assessment) by the research staff. 
Parents will be given the informed consent form (“Informed consent_PRO-Parenting_11.12.19”) and asked to 
read the form. If the parent prefers, research staff will read the form to the parent. Research staff will also 
provide a summary of the study (e.g., timeline for intervention, expectations with regard to pre, post, and 
follow-up assessments, compensation, components of assessment, and potential risks of study). Parents will 
be informed that group assignment is random and that they may be assigned to the Behavioral Parent 
Training-Mindfulness (BPT-M) group or the Behavioral Parent Training-Education (BPT-E) group. Research 
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staff will be available to answer any and all questions the parent(s) has and to address any concerns. Parents 
will be reminded that their consent is voluntary, that they can withdraw from the study at any point, and that 
they do not have to answer any question or participate in any task that they do not want to. Given the young 
age of the children in the study (ages 3 to 5), parents will consent for their children’s participation. Again, 
children will only be involved in one laboratory and four home assessments (at pre-intervention, post-
intervention, and follow-ups) to measure intervention outcomes, but will not be involved in the proposed 
intervention. The participant will be given 30 minutes to consider study participation.
The research study that was described in the consent document signed by participants in cohort 1 was 
modified in response to the covid-19 pandemic. Thus, the study that participants agreed to participate in is 
not exactly the same study they found themselves in after March 2020.  All participants were called by a 
family interventionist in mid-March to notify them that the parent groups would be moving to a virtual format 
in response to the covid-19 pandemic, effective immediately. All participants provided verbal consent to move 
forward in the virtual format.  Consent and date of consent were recorded in an internal tracking 
spreadsheet. The family interventionists called families again a few weeks later to tell them about the Covid-
19 interview, how the “lab” visit would be altered, and the payment for each. Again, all parents provided 
verbal consent to these changes in protocol, and consent and date of consent were recorded in an internal 
tracking spreadsheet. At the time of the post-treatment follow-up, a blank copy of the baseline consent form 
was sent through the mail along with follow-up surveys and a box of assessment materials for the virtual 
home visit. Research staff went over the consent form at the time of the virtual home visit, and provided a 
summary of the study (e.g., confidentiality, compensation, components of assessment, and potential risks of 
study), highlighting changes that had been made due to physical distancing.  To indicate their on-going 
consent, participants signed the copy of the consent form included with their survey and mailed it back to the 
research office.   
In fall 2020 participants in cohort 1 will be contacted by phone and read a script that explains changes in 
study procedures to ensure on-going consent (see “cohort 1 changes to consent script-verbal consent”). 
Verbal consent will be obtained at that time and recorded via Qualtrics form. This script will be shared again 
at the 6- and 12-month follow-up assessments to ensure on-going consent.
Cohort 2
Informed consent will be obtained at the first Zoom appointment (baseline assessment appointment 1) by the 
research staff. Parents will be mailed a copy of the consent form (“Informed consent_PRO-
Parenting_10.7.20”) with their packet of questionnaires. At baseline assessment appointment 1, the research 
assistant will present the consent video, which goes over each element of the consent form (see “Consent 
Script PP_final” and “informed consent slides_final”). Parents will be informed that group assignment is 
random and that they may be assigned to the Behavioral Parent Training-Mindfulness (BPT-M) group or the 
Behavioral Parent Training-Education (BPT-E) group. After the video, the research assistant will offer to 
answer any and all questions the parent(s) has and to address any concerns. Parents will be reminded that 
their consent is voluntary, that they can withdraw from the study at any point, and that they do not have to 
answer any question or participate in any task that they do not want to. Given the young age of the children 
in the study (ages 3 to 5), parents will consent for their children’s participation. Again, children will only be 
involved in observation tasks at four virtual home assessments (at pre-intervention, post-intervention, 6-
month, and 12-month follow-ups) to measure intervention outcomes, but will not be involved in the proposed 
intervention. Children will also be involved in the “lab visit” to complete the Stanford-Binet and ADOS-2 
testing, but only if physical distancing and face covering restrictions are lifted during the study period. If 
restrictions are not lifted, we will forgo this piece of data collection.
Parents will be asked to sign their consent form if they have not already done so, and to provide verbal 
consent to participation in order to continue with the appointment. Research staff will have a copy of the 
consent form available to them via qualtrics. They will check a box to indicate that they have received verbal 
consent before proceeding with the rest of the appointment. 
Both Cohorts
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The PI for this project has had extensive training in conducting research with similar families and has a 
history of federally-funded randomized controlled prevention and early intervention trials. Staff working on 
the project will complete training with the PhD-level project coordinator on providing informed consent and 
administering the standardized protocol.
Because this is a longitudinal study, the research team will have multiple contacts with these families over an 
18-month period of time and will be assessing families via virtual home visits at multiple waves. Prior to each 
wave of data collection, we will send parents a copy of the consent form for them to review. We will begin 
the first virtual home visit of each wave by going over the consent form and asking parents if they have any 
questions or concerns. In this way we will ensure ongoing consent.
Informed consent will be obtained from teachers at each of the four time points of assessment. The research 
team will email a cover letter and an electronic copy of the teacher consent.  Teachers will indicate their 
consent to participate by signing and returning their consent form, and by completing their teacher survey. It 
is possible that a different teacher will report on a given child at each time point. Thus, each wave of teacher 
assessment will include teacher consent forms. The cover letter will include the contact information for the 
Project Coordinator and instructions to contact this person with any questions or concerns about the study. 
The consent form includes contact information for the Research Compliance office if they wish to speak to 
someone other than the research team.
This project is registered on clinicaltrials.gov (NCT03599648). A copy of the consent form will be posted there 
once approved. Results from this research trial will also be reported there once they are available. 
F.
Provisions for Participant Privacy and Data Confidentiality
1. Privacy
To protect the privacy of participants, the research team will take the following precautions:
•
Ask agencies from whom these families are already receiving services to identify potential 
participants for the research study, to share information about the project with them, and to ask 
interested parties to contact our research team if they desire more information about the project. In 
this way, we will not know the identities of all families at the agency who qualify for the study, but 
only those who reach out to us to indicate interest in participation;
•
Assess families in their homes to ensure their privacy, safety, and comfort;
•
Once it is safe to do so, conduct lab assessments in our PSI-Portland lab in assessment rooms with 
doors that close, or at the King School in empty classrooms with doors that close, and with white 
noise machines located in the hallway to reduce the possibility of those outside the room hearing 
private conversations;
•
Allow families to identify the teacher who will provide data about their child;
•
Collect questionnaire data via Teleform survey with participant ID numbers printed on them rather 
than participant names or other identifying information. Our Teleform surveys will invite participants 
to “bubble in” their responses to multiple-choice questions rather than respond in ways in which 
handwriting might easily be identified;
•
Collect questionnaire data via Qualtrics survey with a “special word” used to link surveys to child 
participants rather than participant names or other identifying information. Our Qualtrics surveys will 
invite participants to select their responses to multiple choice questions rather than respond in ways 
in which handwriting might easily be identified; and
•
Use the HIPAA-compliant version of Zoom, which establishes strict access control rules and strong 
AES256 encryption to prevent transmission of any PHI (protected health information), for remote 
home visits and parent groups. Parent intervention groups will be recorded in order for research staff 
to evaluate group leaders’ fidelity to the intervention model. In addition, the “virtual home visits” will be 
recorded via Zoom so that coding staff may observe and code family interactions. In each of these 
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cases, meetings will be recorded to the local machine (not the cloud), uploaded to the project file on 
the PSI secure server, and then deleted from the local machine once the recordings have been safely 
transferred to the server. 
To protect the privacy of participating teachers, the research team will take the following precautions:
•
Refuse to share information provided by teachers with the child or his/ her parents;
•
Collect questionnaire data via Qualtrics survey with a “special word” used to link surveys to child 
participants rather than participant names or other identifying information. Our Qualtrics surveys will 
invite participants to select their responses to multiple choice questions rather than respond in ways 
in which handwriting might easily be identified.
2. Data Disposition and Confidentiality
Consent documents will be stored in locked cabinets in a locked room within the PSI lab in Portland, which is 
located on the University of Oregon-Portland campus (a locked building with a security team). After 7 years’ time, 
the consent documents will be disposed of through a recycling service contracted by PSI.
To protect confidentiality, data will be coded by subject number rather than name, and all identifying information 
will be kept separate from the data. Only the Data Manager, Project Coordinator, and Assessment Coordinator will 
have access to the key that links names to subject numbers. This key must be retained in order to link participant 
data over time in this longitudinal study. All hard copies of measures will be kept at PSI-Portland in a locked 
storage cabinet that is kept in a locked room within a locked research building until it is transferred between sites 
by project staff in a locked box. PHI will be blacked out before data is transported to Eugene. Once files arrive in 
Eugene, they will immediately be stored in locked cabinets, in a locked room, in a locked building.
Data collected through Qualtrics is protected by Qualtrics’ high-end firewall systems. Their servers are scanned 
regularly to ensure that any vulnerabilities are quickly found and patched, and complete penetration tests are 
performed yearly. Their confidential system component design uses multiple checks to certify that packets from 
one subsystem can only be received by a designated subsystem.  Access to systems is severely restricted to 
specific individuals, whose access is monitored and audited for compliance. Qualtrics uses TLS encryption for all 
transmitted data, and they protect surveys with passwords and HTTP referrer checking. Qualtrics’ services are 
hosted by trusted data centers that are independently audited using the industry standard SSAE-16 method.
In addition, all hard copy and electronic data will be stored by identification number only. Electronic copies of the 
data will be stored on University-owned computers and servers with strong passwords for future analyses. Data 
will be saved in a secure location on the PSI server. If a portable device (e.g. laptop or video camera) is used at 
any point in the study, the device will be encrypted, data will only be stored on the device temporarily, and the 
device will be stored in a physically secure location (e.g. locked in laboratory room). Access to the data is 
restricted to authorized study personnel. Data will be retained in locked files until it is clear that no further analyses 
will be done.
Parent intervention groups and “virtual home visits” will be conducted via Zoom videoconferencing services.  
Zoom is accessible to all UO faculty members, staff, and students. For UO Zoom users who handle HIPAA-
regulated data, a HIPAA-compliant environment is available that includes Zoom, which establishes strict access 
control rules and strong AES256 encryption to prevent transmission of any PHI (protected health information). All 
research staff members who use Zoom for data collection purposes have acquired the HIPAA-compliant version 
of Zoom. Parent intervention groups will be conducted via Zoom and recorded in order for research staff to 
evaluate group leaders’ fidelity to the intervention model. In addition, the “virtual home visits” will be conducted via 
Zoom and recorded so that coding staff may observe and code family interactions. In each of these cases, 
meetings will be recorded to the local machine (not the cloud), uploaded to the project file on the PSI secure 
server, and then deleted from the local machine once the recordings have been safely transferred to the server. 
 
Copies of questionnaires and video recordings will ultimately be stored in Eugene at the University of Oregon 
(UO) at the Prevention Science Institute (PSI) for data management and coding. Videotaped recordings obtained 
from subjects will be uploaded from PSI-Portland to a secure STP from which project staff at the PSI-Eugene can 
access the information for management and coding. Videos will then immediately be deleted from the video 
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camera (or local machine, in the case of Zoom recordings). All paper questionnaires will be entered through 
Teleform scanning at PSI-Eugene.
The Prevention Science Institute (PSI) is isolated from the rest of the University of Oregon network using high end 
network firewall appliances (WatchGuard Soho 6). The PSI network uses industry-standard IPSec VPN protocol, 
which uses Triple DES Encryption, one of the strongest encryption types currently in use. All data files are 
protected by an authentication scheme, providing access to only a small group of trusted users who require 
access, thus reducing the exposure of sensitive data. 
The informed consent form states that information about the family cannot be released to anyone other than the 
consenting parent unless the parents have granted written permission. The informed consent form states that 
information about the child can be released only if the investigators learn of physical or sexual abuse of the child 
or the investigators learn that someone is in imminent danger of harm. There is no plan to release data to any 
agency. Information provided by one study participant (mother, father, teacher, youth) will not be shared with any 
other participants. These stringent safeguards are likely to be effective and will remain to fully protect the 
participants, with very little likelihood of risk.
A Certificate of Confidentiality will automatically be granted to this project by NIH.
The information gathered in this study will be used for scientific, educational, or instructional purposes and will 
only be reported in aggregate form without identifying information or individual cases.
G. Potential Research Risks or Discomforts to Participants
Risks for participants are minimal. All procedures for this study have been used widely in previous research, with 
little to no discomfort or risk to either the parents or the child. Nevertheless, some of the questions in the 
questionnaires and interviews do seek personal information, and might be considered an invasion of privacy (e.g. 
questions about the marriage). Some young children may show mild frustration or distress during the home 
situations involving parents placing demands on their child (e.g. asking them to clean up). Additionally, the child 
may also face some mild frustration / boredom during the “lab visit” while completing the ADOS due to its length 
(approximately 40-60 minutes). In the PI’s experience using these tasks in similar studies, the risks or likelihood of 
discomfort is minimal. In order to minimize risks, participants will have the right to refuse to answer any question 
or terminate their involvement in the study at any time. In order to minimize demands on the parent and child, the 
assessments will not be longer than one hour, with the exception of the baseline assessment, which may take 
longer due to the inclusion of two additional questionnaires. However, parents and children will be able to take 
breaks as needed.
Other potential risks and discomforts involved in participation include possible violation of confidentiality, possible 
misunderstanding regarding the use of data, and minimal psychological risk resulting from possible feelings of 
coercion about consenting to participate in components of the study. To minimize these risks, the research 
procedure and precautions taken to protect privacy are explained to potential participants both verbally (via video 
recording and/ or research assistant) and on the consent forms at each phase of the research. All 
parents/guardians are required to read and sign a detailed consent form before participating in the study. The 
consent form fully emphasizes the voluntary nature of participation, the participant’s right to withdraw from the 
study at any time without penalty, and their right to have all data relating to the child or family removed from data 
analysis. Parents will review these consent forms prior to each follow-up assessment to remind them of these 
potential risks. All teachers will receive a consent form with their survey. Teachers will indicate their consent by 
returning completed consent forms and surveys to research staff. Teachers will receive a new copy of the consent 
form prior to any follow-up assessments in which they participate. Teachers will be assured that the information 
that they share with investigators will remain confidential and will not be shared with the child or his/ her parents.
Should parents/caregivers, target children, or teachers experience an adverse reaction to the assessments and 
require medical or psychological assistance, project staff will be prepared to evaluate the situation and, if 
necessary, make appropriate referrals. Referrals will be made by the PI, who is a licensed psychologist and is 
prepared to make referrals to community mental health providers.
We have a Data Safety and Monitoring Plan (DSMP) in place for this research project. (Please see “Data Safety 
and Monitoring Plan.”) 
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H. Potential Benefits of the Research
All participating caregivers receive intervention to promote positive parenting and reduce child behavior problems. 
Those randomized to receive the BPT-M will also receive intervention targeting stress reduction. Thus, potential 
benefits of participating in this research include possible reduction in parental stress, possible improvement in 
parenting behaviors, and possible decline in children’s behavior problems. All participants, regardless of condition 
(BPT-M or BPT-E), will receive assessments from trained staff and may feel positive benefits associated with 
participating in a research study. These assessments may also offer participants the opportunity to reflect and 
gain perspective about their family’s needs and priorities. In addition, parents will receive a short summary of their 
child’s current and previous behavioral functioning based on study assessments after completion of the 12-month 
follow-up visit. This may be especially valuable to families given disparities associated with access to services and 
resources for underserved, under-represented families of children with ASD. Parents will also have access to 
research staff with expertise in child development and DD to answer questions about their child’s development, 
need for services, and local resources.
Community practitioners may benefit from this research because they will have opportunities to refer families to 
participate in this study. Family-based interventions are not available in all communities; thus, practitioners may 
appreciate the opportunity to refer families to participate. If findings support the efficacy of the BPT-M on child and 
family outcomes, community practitioners may wish to incorporate aspects of this intervention in their community 
care. 
The scientific community may benefit from the knowledge gained in respect to the efficacy of the BPT-M in 
families with young children with DD, an area that is virtually unexplored. The risks associated with this study are 
minimal in comparison with the benefits that family members, community practitioners, and the scientific 
community may experience. If study findings suggest that the BPT-M has effects on promoting healthier child and 
family outcomes, relative to a standard behavioral parent training with an education component (BPTE), and can 
be delivered in a cost-effective manner, this intervention has the potential to make revolutionary contributions to 
both the practitioner and the scientific communities.
I.
Investigator Experience
Dr. Laura Lee McIntyre, PI, is a licensed psychologist and board-certified behavioral analyst with more than 
20 years of experience working with children with DD and their families, including a focus on early 
intervention and prevention of behavior problems. She has experience adapting evidence-based interventions 
for use with families of children with DD, and she completed and RCT that assessed the efficacy of BPT in a 
sample of preschool-age children with DD and their families and recently completed a large-scale RCT of this 
intervention.  Dr. McIntyre has a strong record of community partnerships, and she and her team have 
recruited more than 300 families across these funded projects.
Dr. Cameron Neece, Co-PI (PI of Loma Linda site), is also a licensed psychologist with experience working 
with diverse community samples of families with young children with DD. During the past 6 years she has 
conducted a study using waitlist-control design to examine the feasibility and efficacy of MBSR for a diverse 
sample of parents of preschool children with DD.
Dr. Allison Caruthers, Project Coordinator, is a developmental psychologist with 23 years of data collection 
experience, including 14 years as a Project Coordinator and Research Associate on various projects at the 
Prevention Science Institute. In this role she has created research protocols and consent processes, and 
trained and supervised dozens of research staff to adhere to these protocols.
Nicole Smith, Assessment Coordinator, has 6 years of research experience at PSI, in which she has worked 
closely with research protocols, consent processes, and data collection procedures.
Roles and Research Duties
The Principal Investigator and Co-PI will be in charge of oversight of all project activities and data analysis, as 
well as training and supervision of clinical staff.
The Project Coordinator will be in charge of all day-to-day research activities and communications with PI and 
Co-PI.
Research Compliance Services
Approved 10/17/2024 - 10/31/2024

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7.14.2021 
The Assessment Coordinator will be in charge of training and supervising research assistants and ensuring 
high quality data collection. 
The Data Manager will be in charge of randomly assigning participants to condition, and cleaning and 
organizing data to prepare for analysis.
The Recruiters will be in charge of conducting phone screens to determine eligibility to participate in the 
research study.
Data Collectors will be in charge of conducting home visits, reviewing parent surveys with parents to ensure 
minimal missing data, and guiding the family (and recording them) in the videotaped play tasks.
Interventionists will be in charge of leading the parent groups and teaching from the Incredible Years 
curriculum.
Training and Oversight
All research staff who will have contact with participants and/ or data will complete the CITI training course, 
including the Good Clinical Practice training module, in order to ensure proper understanding of ethics 
involved in human subjects’ research.
Research staff involved in the collection of questionnaires and observational data will be trained by the 
assessment coordinator to follow the protocol written for this project to ensure uniformity in data collection 
and handling.
Research staff responsible for coding family observations will be trained by our Coding Lab Supervisor in the 
appropriate application of our observation coding systems. At least 25% of tapes will be coded by a second 
observer to ensure adequate inter-observer agreement (80% agreement or better).
Research staff responsible for conducting clinical lab assessments of child development and autism symptoms 
will have graduate-level training in these assessments and/or advanced trainings from the PI or other trained 
staff, and will receive ongoing supervision from the PI. 
Research staff responsible for running the treatment groups will be trained and supervised by the PI or 
another doctoral-level, licensed psychologist.
Research Compliance Services
Approved 10/17/2024 - 10/31/2024