Improving Delay Discounting to Decrease Harsh Parenting Among Parents Receiving Substance Use Treatment in Low Income Community
Phase: NA
Conditions: Behavioral Health
Sponsor: Henry Ford Health System

Study Title: Improving Delay Discounting to Decrease Harsh Parenting Among Parents 
Receiving Substance Use Treatment 
NCT #:  NCT05229120 
Protocol Title: Fast Forward: Future Thinking to Improve Parent-Child Relationships 
7 December 2023 
IRB #: 14781-29
Dr. Julia Felton 

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STUDY TITLE: Fast Forward: Future Thinking to Improve Parent-Child Relationships 
 
1. STUDY AIM, BACKGROUND, AND DESIGN ABSTRACT 
 
The aims of the current study are to conduct a small case series (up to N=30) to evaluate the preliminary 
feasibility of implementing a brief, episodic future thinking (EFT) intervention in a substance use 
treatment setting serving low-income parents. 
 
Episodic future thinking (EFT) refers to the ability to imagine, in vivid detail, events that may occur in the 
future (Lin & Epstein, 2014). EFT relies on episodic memory, which allows for recollection of past, 
personal experiences. Research has shown that episodic memory supports the creation of positive, 
future events by combining past experiences with vivid detail of events that may occur in the future. 
Recent studies have shown that EFT intervention can decrease delay discounting (DD), which is a facet 
of impulsivity (Dassen et al., 2015; Snider et al., 2019; Stein et al., 2016). 
 
The overarching goal of this EFT intervention is to increase parents' focus on positive, future events 
associated with enhancing the parent-child relationship. Rather than trying to decrease negative 
parenting practices, the focus of this study is to promote positive parent-child relationships by 
envisioning future-directed events. To date, no research has examined EFT in relation to parenting 
behaviors. Moreover, the intervention requires limited time and financial resources to implement, 
suggesting it may be effectively delivered in a disadvantaged community. The current application of EFT 
proposes to examine the efficacy of EFT in improving parent-child relationships in the low-resource, 
minority-majority community of Flint, Michigan. Results from this case series will inform a revision of the 
intervention with respect to dosage and feasibility outcomes. 
 
Aims of this study include: (1) determining the implementation potential of this intervention (including 
feasibility, acceptability, and satisfaction) and (2a) examine preliminary efficacy of this intervention in 
reducing parental delay discounting (focus on immediate relative to long-term rewards) and (2b) 
improvements in parent-child relationships/parenting quality and related constructs. 
 
2. SUBJECT POPULATION AND ELIGIBILITY 
 
Up to 30 parents will be recruited participate in this study from an inpatient substance use treatment 
center (Flint Odyssey House), in Flint, MI with a secondary location in Saginaw, MI (“Odyssey House” 
will be used from here forward to indicate both sites). This research includes individuals currently 
receiving inpatient substance use treatment. Individuals with substance use disorders (SUD) and those 
from impoverished areas are more likely to have shortened time horizons and have more difficulty 
picturing positive future events with their children. 
 
Inclusion criteria: 
1. Be the parent of a child between the ages of 6-10 
2. Willing to participate in the study 
3. Able to participate in written assessments and an intervention conducted in English 
4. Are receiving services at Flint or Saginaw Odyssey House (“Odyssey House”) 
5. Be willing to receiving daily post cards andmeet regularly with a peer recovery coach over the course 
of two weeks following the initial intervention 
6. Can legally consent for the child to take part in the study and are with their child 50% of the time. 

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Exclusion criteria: 
1. Self-disclosed active suicidality/homicidality 
2. Self-disclosed current bipolar disorder, schizophrenia, or psychosis 
Children will not directly take part in the intervention; however, they will be included in the observational 
tasks with enrolled parents that are part of the larger assessment battery to evaluate changes in 
parenting. Children above age 7 will be verbally assented prior to participating in the observation. 
Outside of the assent procedures, research team members will not directly interact with children that are 
participating in the observation. If the interested individual has more than one child in the age range (5-
10 years old) we will ask them to complete the observation session with their youngest child in that age 
range. 
 
In addition to parent enrollment, we will conduct up to 10 key informant interviews with stakeholders at 
Odyssey house, including Odyssey House leadership and peer interventionists, to obtain feedback on 
the intervention and any improvements that can be made. 
 
Enrollment and/or Screening 
 
Parent participants will be recruited using flyers displayed at the facility, announcements made at 
regularly scheduled resident meetings and/or approached directly to gauge interest in participating. 
 
The Odyssey House Clinical Supervisor or other study staff (e.g., Peer) will approach potentially eligible 
participants to discuss the study and, if the participant expresses interest in participating, conduct the 
screening procedures to determine eligibility. All individuals will be informed that participation is 
completely voluntary, will be kept confidential, and will not impact their access to services in any way. 
The clinical supervisor or study staff conducting screening procedures will then document whether the 
participant meets eligibility criteria and record this information in the secure study REDCap database. 
 
Once an individual expresses interest in taking part in the study and is determined to be eligible, a Peer 
will be assigned to approach the participant to obtain consent. The participant and the Peer will 
determine a time that is mutually convenient for them to conduct the consent process and initial 
assessment. Odyssey House is a residential treatment center; therefore, screening, consent processes, 
assessments and the intervention will be conducted in small, private rooms located at Odyssey House. 
During this scheduled meeting time, the Peer will explain the study to the participant and go through 
consent procedures. No data beyond eligibility will be collected prior to enrolling in the study. No medical 
records will be accessed as part of this study. If the interested individual does not meet 
inclusion/exclusion criteria (“screens out”), they will be offered a resource list of free or reduced cost 
resources in the Flint area. 
Stakeholder Enrollment – Key Informant Interviews 
Stakeholders, including peer interventionists and Odyssey House leadership/staff that were involved in 
the project, will be approached via phone or email or in person at Odyssey House and asked if they 
would be willing to take part in a one-time interview. Interested individuals will be included. 
3. STUDY PROCEDURES 
 
Study procedures will only be carried out by Odyssey House or HFH staff that are 1) adequately trained 
on the study protocol and procedures and 2) listed as key personnel on the IRB with documentation of 
completion of CITI and any applicable training requirements. Anyone that does not meet those criteria 
will not carry out any study procedures. 

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Following screening, eligible and interested parent participants will meet with a study Peer to begin 
consent procedures. During consent procedures, the participant will be informed that the intervention 
session, observation, and key informant interview will be recorded for research purposes. If the 
participant consents, the participant will be provided a copy of the signed consent. 
After consent procedures, participants will be asked to take a pre-assessment battery. The assessment 
battery may be split into multiple sessions as needed based on participants’ request, attention span, or 
time availability. The assessment battery will include measures of (1) delay discounting (DD) (Aim 2a), 
(2) consideration of future consequences (Aim 2a), (3) child behavior (Aim 2b), and (4) parenting 
variables (Aim 2b). To measure DD, we will use the Monetary Choice Questionnaire (MCQ). To assess 
how the participant considers the future while making decisions (both in general and with their child), 
using an adapted (to focus on parenting) version of the Consideration of Future Consequences Scale 
(CFC). To assess child behavior, we will use the Strengths and Difficulties Questionnaire (SDQ) – age 
4-10, and child behavior questions from the Children’s Health Questionnaire. In order to assess 
parenting characteristics, we will use the Aggravation in Parenting Scale (APS; a measure of parents' 
perceived aggravation related to parenting), the Alabama Parenting Questionnaire (APQ; a measure of 
different parenting behaviors), Parenting Laxness questions (from The Parenting Scale), Parent-Child 
Conflict Tactics Scale, Parenting Joy, and the Parenting Stress Index (PSI-4). At the last assessment 
only, parents will also complete a client satisfaction questionnaire (CSQ) and a Working Alliance 
Inventory (WAI). Additionally, the peer interventionist will complete a brief measure of their perceptions 
of participants’ engagement in the intervention. 
All questionnaires are hosted in the study’s secure REDCap database will be completed on a password 
protected computer and encrypted, unless use of the computer is unavailable/impractical (internet 
outages, disruptions to REDCap, etc.) in which case participants will be able to fill out forms using 
paper-and-pencil. All measures have proven psychometric properties and are validated for the parents 
of children ages 6-10. 
As soon as possible after the pre-intervention assessment is completed, if the participant’s child 
assents to participate, we will complete a 20-minute observation that will be videotaped and led by 
either the peer or other study staff. Verbal child assent will be obtained from the child prior to beginning 
the observation and assent will be documented in REDCap. During the observation, the parent and 
their child will complete a clean-up, homework, and play task. The interaction will be videorecorded, 
and recordings will be stored on a password protected servers and accessible only to study staff. 
Behavior will be coded using a standardized coding procedure (the DPICS). Although the observation 
will only last approximately 20 minutes, we will ask to schedule these sessions for 40 minutes to allow 
time for child assent and instructions. All assessments (including the questionnaires and videotaped 
interaction) will be administered by either a Peer or by study staff, depending on Peer availability. 
Compensation for the pre-assessment (assessments and observation session) will be $15. 
Approximately one week after the pre-intervention assessment is completed, the participant will take part 
in the EFT intervention, led by a trained peer parent or the PI. The intervention session will last 75- 90 
minutes in total and will be recorded for fidelity and to accurately capture each participant-generated 
episode. The session will begin by the PI/interventionist providing a general overview of the study and 
reviewing confidentiality. The participant will be asked to discuss their relationship with their child and to 
give examples of both positive and negative parenting from their personal experience. The 
interventionist will ask the participant to think about their long-term parenting goals and will discuss how 
to create a vivid event that will be easy to remember. Finally, several timepoints (based on important 
future milestones the participant identifies) will be used to create EFT events. The interventionist will 
create short cues from these events that will then be sent to the participant via postcard once a day for 

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two weeks. Cues will also be briefly discussed by the peer and participant at several points over the 
subsequent two weeks. The interventionist will document each check-in for tracking purposes. Peers 
may split the intervention into more than one meeting depending on participant need/response (related 
to fatigue, attention, etc.). Immediately following the intervention, parents will complete the MCQ and 
Parenting Joy survey again. Over the following two weeks, participants will be sent daily postcards 
including the cue phrase (designed to trigger recall of the future episode they identified during the 
intervention) and briefly meet with a peer to recall the scenes they envisioned and remind them of what 
they discussed during the intervention. The participant will receive $14 at the end of two weeks for 
meeting regularly with the peer (between 3-7 times over the two weeks). The cumulative earned 
incentive amount will be paid. 
 
Two weeks after the intervention session, participants will complete a post-assessment battery. This 
assessment will include the same measures as the pre-assessment battery, with the exception of the 
demographics and items from the Children’s Health Questionnaire. Additionally, participants will 
complete a brief measure of intervention satisfaction and working alliance. Peer interventionists will also 
be asked to rate how engaged they felt the participant was during the intervention. The post- 
assessment will also include a second observation session with the parent and the same child with 
similar tasks to the initial observation session. Participants will be given $15 for completing the post- 
intervention assessment. 
 
Following completion of the intervention, participants will also be given an opportunity to receive an 
additional $15 for taking part in a 30-minute key informant interview (KII; see KII script) that gauges 
participants’ views on their perceived acceptability and satisfaction with the intervention and study 
processes. These interviews will be audio-recorded; recordings will be kept on secure servers, 
accessible only to the study team, and deleted after 3 years. Participants will receive $15 for completion 
of the KII. 
 
After completing all study procedures, all participants will be offered a resource guide of free and low- cost 
resources in the Flint area. 
 
Thus, in total, there will be four study visits/interactions: (1) the initial (baseline) assessment; (2) the 
intervention; (3) the post-intervention assessment; and (4) the key informant interview (which may be 
completed over the phone, based on participant preference). 
 
The interventions will be conducted by peer parents. These will be individuals who are already employed 
by the agency and are certified as peer recovery specialists by the State of Michigan. Agency and center 
staff will identify peer parents who would be appropriate to engage in this work. Peer parents will then 
be approached and asked if they are interested; they will be informed that working on this study is 
optional and that their employment is not contingent on participation. These procedures were created in 
conjunction with leadership from Odyssey House and peers’ time will be supported by grant funding. 
Peers will be trained by the PI (Felton) and provided weekly and as-needed supervision, including 
individual review of taped session for fidelity and training purposes. All recordings of peer- participant 
interactions will be stored on password protected servers and will be destroyed following the three-year 
requirement for data storage. All peer parents (once selected) will be added to the IRB as research 
assistants and complete all required human subjects training. We elected to utilize peer parents given 
strong evidence that peers are perceived as less stigmatizing and, with training, are able to implement 
straight-forward interventions with fidelity. 
 
In the event that a parent is discharged from, leaves Odyssey House after enrollment, or needs to pause 
study procedures for another reason, the parent will not automatically be withdrawn from the study and 
will be allowed to continue in the study if they wish. For those that have left Odyssey House and want to 
continue, we will work with the parent to determine a convenient location to complete the study 

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procedures (e.g., another Odyssey House facility, their home, another residential center, etc.). In some 
circumstances, parents may leave Odyssey House without warning and, since we don’t have their contact 
information, would essentially be lost to follow up unless they return to Odyssey House. 
Their data would remain in the study for any study procedures that were completed prior to 
discharge/leaving unless they ask to be withdrawn from the study. If the parent leaves and returns to 
Odyssey House and wants to resume the study, study procedures can resume. For anyone in which 
there is a long pause in study procedures (due to discharge or other reasons), we would potentially ask 
the parent to retake the baseline assessments or other study procedures if an extended period of time 
has passed since initial completion. 
 
We estimate that it will take 2-4 months to recruit and train peer parents, 2-4 months for recruitment of 
participants, 2-4 months for running the study, and 2-4 months for project wrap-up and data analysis 
from the time of grant award. 
 
Additional Information: 
*This project is currently funded by an award from NIDA/ NIH. 
*Since this is a pilot feasibility study, the sample size was selected to provide sufficient information 
regarding implementation outcomes and detect signal on outcomes. Findings from this project will be 
used to adapt the intervention for a larger RCT. 
*The PI will conduct all analyses. She received a minor-specialization in qualitative methods as part of 
her doctoral studies and serves as the statistical consultant on two NIH-funded treatment development 
grants. 
 
Weeks from 
Enrollment 
1 
2 
3 
4 
5-6 
Activity 
Assessment 1 
(surveys and 
observation) 
Intervention 
(+MCQ and 
Parenting Joy 
survey) 
Daily postcard 
messages and 
regular (3-7) 
check-ins with 
peers over 2 
weeks 
Assessment 2 
(surveys and 
observation) 
KII 
Incentives 
$15 
$14 
$15 
$15 
 
Stakeholder Procedures – Key Informant Interviews: 
 
Interested stakeholders will meet with a study team member remotely, using a secure video platform 
(e.g., Webex), or over the phone for a 30-minute semi-structured interview. The interview asks several 
questions about the acceptability of the program, any challenges, and potential room for 
changes/improvements. The interview will be recorded, and the recording will be transcribed. 
 
Study details will be discussed prior to each interview. Stakeholder consent will be obtained orally prior 
to beginning the interview. Stakeholders will be informed that by participating in the interview/survey they 
are consenting to participate in the study. Stakeholders will be compensated $30 for completion of the 
interview. 
 
4. ANTICIPATED RISKS 
 
One potential risk to participants in this study is a loss of confidentiality. To mitigate this risk, all research 
staff, including peer parents, will be trained in the protection of human subjects and will be instructed in 
maintaining strict confidentiality. In order to de-identify data, we will assign each participant a random 
identification number. Only these numbers will be associated with the assessment materials. One 

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master document that links participant names and numbers will be retained in a password protected 
computer file accessible only to authorized study staff. Participants will be assured that the decision to 
take part in the study will not affect access to programming or resources. While participation in the 
program involves completing the intervention at Odyssey House, receiving postcard reminders, and 
touching base with peer interventionists regularly over two weeks (thus making it possible for other 
individuals to observe participants being administered the intervention or receiving study-related 
communications), we believe this risk is minimal. However, we will also attempt to conceal participation 
status in a number of ways. Peer parents will be trained to take reasonable precautions to prevent 
revealing parents’ participation in the program, including closing the door to the intervention room and 
not referring to participants’ status in the intervention outside of this private space. 
 
We expect any discomfort participants may feel while completing assessment questionnaires (i.e., 
frustration, boredom, and fatigue) to be short-lived. However, in the event that participants are either 
disturbed or concerned about reactions to the questionnaires, we will encourage them to discuss these 
concerns with the research staff. They will be put in touch with mental health staff at Odyssey House, 
and/or the PI (Felton), a licensed clinical psychologist, if concerns are not satisfactorily addressed. We 
will also discuss with all participants the nature of the Certificate of Confidentiality during the assent and 
consent procedures. If participants report feeling uncomfortable answering certain questions, they will be 
reminded that they are allowed to skip items and still be compensated for participation. Based on 
previous experiences collecting data from low-income adults, we anticipate very low levels of non- 
response. 
 
In the event that a participant discloses suicidal ideation or intent, involvement in psychical 
abuse/neglect, and/or urgent physical and mental health concerns arise for the parent or child, the RA 
or interventionist will confer with Dr. Felton and the medical and mental health providers on staff at 
Odyssey House to determine next steps. Dr. Felton, in collaboration with medical and mental health 
providers at Odyssey House will determine the appropriate course of action. In extreme circumstances, 
this may involve contacting authorities. The PI (Felton) and Co-I Chronis-Tuscano have conducted 
similar clinical trials and Dr. Felton has also used similar methods and interventions with Flint, MI-based 
samples and, from this experience, believe the possibility of having to report participants to authorities is 
extremely rare. Given that we are not specifically asking about suicidality, we also expect any 
spontaneous disclosure of suicidality by the participant to be extremely rare. Nevertheless, any 
participant disclosure of harm to self or others will be treated seriously and the PI will immediately and 
directly contact Odyssey house medical and mental health providers to follow-up with the participant to 
clarify their report of harm to self/others and gather more information.  
 
In the rare event that such disclosures are determined to be required by law, we will report only 
information directly provided by the participant related to child maltreatment (defined as physical or 
mental injury, sexual abuse, neglect, or other circumstance whether the welfare of the child is 
threatened). Prior to participation, participants will be given clear verbal and written details (during 
consent procedures) around these requirements and informed of the research team’s ethical and legal 
obligations to protect the safety of vulnerable individuals. Participants will also be given multiple 
opportunities to ask questions regarding both reporting requirements and the reporting process and 
encouraged to reach out to the PI (a licensed clinical psychologist) to address any concerns that they 
may have. Participants who are reported to authorities under these circumstances will be allowed to 
remain in the study, but their data will not be used and a replacement participant will be recruited. The 
research team has already fully discussed these reporting requirements and received support for these 
procedures from agency leadership at both recruitment sites. Researchers have worked extensively with 
Odyssey House staff on the development of research procedures, including addressing any concerns 
the provider may have that may arise during the completion of this project. 
 
 

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Stakeholders 
 
The only foreseeable risk to stakeholders is discomfort at answering some of the questions. We do not 
anticipate this to be frequent and stakeholders are able to skip any questions they don’t want to answer. 
 
5. ANTICIPATED BENEFITS 
 
The primary anticipated benefit of this research to parents and society is the possible improvement in 
parent-child relationship quality and related constructs. 
 
6. RENUMERATION/COMPENSATION 
 
Parent participants will be offered payment for taking part in each assessment (including written 
assessments, parent-child observation sessions and key informant interviews), as well as completing daily 
practice of the intervention over two weeks. Incentives will be provided on ClinCards. 
 
Weeks from 
Enrollment 
1 
2 
3 
4 
5-6 
Activity 
Assessment 1 
(observation and 
assessment) 
Intervention + 
MCQ and 
Parenting Joy 
survey 
Daily postcard 
reminders and 
regular (3-7) 
check-ins with 
peers 
Assessment 2 
(observation and 
assessment) 
Interview 
Incentives 
$15 
$14 
$15 
$15 
 
Stakeholders will receive a one-time payment for completion of the key informant interview. Incentives 
for stakeholders will be provided on ClinCards. 
 
7. COSTS 
 
There are no costs to the participant to take part in this study. 
 
8. ALTERNATIVES 
 
The alternative to participants is not participating in this research. 
 
9. CONSENT PROCESS AND DOCUMENTATION 
 
Research assistants (peer parent) will meet with eligible parent participants in small, private rooms at at 
Odyssey House to review the consent form and answer any questions that participants may have. If a 
participant appears to be under duress or undue influence or does not have sufficient time to complete 
the consent procedures, a follow-up meeting will be scheduled. As part of the consent process, the RA 
will explain the study, its duration, risks and requirements and allow the participant to ask any questions 
they may have. Participants will be informed that they will be identified only by a randomly assigned 
number and that only one log linking their ID and names will be kept in a password protected computer file 
stored on a secure HITECH-compliant server and accessible only to a small number of authorized 
members of the research team. They will also be informed that the intervention session, parent-child 
interaction, and the key informant interview will be recorded for research purposes and that these 
recordings and all evaluation materials and the log linking participant ID and names will be stored 
securely, only accessible to the study team, and destroyed three years after completion of the 
intervention. The participant will be provided a copy of the signed consent. 

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All consent documents will be stored in a locked file cabinet in a secure location at Odyssey House or 
Henry Ford Health System and kept apart from any other study data. 
 
All children over the age 7 and older participating in the observation session will be assented before the 
observation with their parent begins. Prior to taking part in the observational assessment, a research 
assistant will explain their participation in the study (over phone or web conferencing) and allow for time 
for the child to ask questions. Verbal assent will be documented in REDCap. 
 
Stakeholder Consent – Key Informant Interviews: 
 
For stakeholder interviews, we are requesting a waiver of written consent. The interview poses no more 
than minimal risk, and a written consent form would be the only record linking the stakeholder 
participant to the study – we are otherwise not collecting any identifiable data as part of the interviews. 
The stakeholders are not receiving an intervention and involve no procedures for which written consent 
is normally required outside of the research context. Consent information will be reviewed with all 
stakeholders prior to beginning the interview, and we will provide stakeholders with a copy of the 
consent information sheet to review and keep. 
 
10. WITHDRAWAL OF SUBJECTS 
 
There are no anticipated circumstances under which participants will be withdrawn from the research 
without their consent. This includes participants that leave Odyssey House – they will not be withdrawn 
and can continue in the study if they are interested in doing so. Participants who decide to withdraw will 
not face any penalty or denial of services. 
 
11. PRIVACY AND CONFIDENTIALITY 
 
All participants will be assigned a random study ID. Only one log linking participants names and their IDs 
will exist and it will be kept separate from all other study materials (including consent forms and 
assessment packets/recordings). All study materials will be kept in encrypted data files on a password 
protected computer. Consent forms will be kept separately from study data and will be housed in locked 
areas in secured offices at Henry Ford or Odyssey House and accessible only by the study team. For 
stakeholder participants, no identifiable information will be collected. Study materials will be collected 
by research team members and will only be used by members of the research team. All study materials 
will be destroyed three years after the completion of the study, consistent with recommended guidelines. 
All video and audio recordings will be saved with study ID only on a secure folder on secure servers at 
HFHS or Odyssey House. Only study personnel will have access to this folder and the video recordings. 
Audio files will be uploaded to a secure AI-based transcription platform for transcription purposes. 
Transcripts will be reviewed by the study team and any PHI will be removed before saving the file to a 
secure study folder accessible only to the research team. Audio files and transcripts will be saved with a 
study ID only. Once transcribed, audio files will be deleted as soon as possible. 
 
In addition, a Certificate of Confidentiality (CoC) is automatically given to all NIH-funded studies to 
protect the privacy of research subjects by prohibiting disclosure of identifiable, sensitive research 
information to anyone not connected to the research except when the subject consents, or when 
required by law for reporting medical emergencies, serious threats of harm to self or others, child abuse 
or neglect, or elder abuse. 
 
 

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Important HIPAA Concerns 
 
No medical records are being used for this study. 
 
12. DATA ANALYTIC AND SAFETY MONITORING PLAN 
 
Dr. Felton will be responsible for overseeing the implementation and execution of the data and safety 
monitoring plan. All research staff (including peer parents) will complete relevant human subjects 
protection training. Dr. Felton will also ensure that all participants in the study meet specified 
inclusion/exclusion criteria by reviewing enrollment with research staff at regular study team meetings. 
Data will be monitored on an ongoing basis and reviewed by the PI at regular intervals to identify any 
problems or concerns. Analyses will be conducted only after all data is collected, deidentified, and 
cleaned, thus limiting the possibility of deidentification.  
 
Any findings shared with community stakeholders will be done in aggregate and reflecting mean-level 
trends. Data will be safeguarded against breaches of confidentiality using the procedures outlined 
above. These processes include removing identifiable information from data and coding assessment 
forms with ID numbers only. All data will be kept securely in locked file cabinets accessible only to 
research staff. Community partners and peer parents will not have access to any assessment materials. 
Any computers containing electronic data files will be password-protected, stored in locked cabinets in 
locked offices, and accessible only by study personnel. Only the research staff will have access to the 
data. The Certificate of Confidentiality from NIH which will protect against requests to disclose sensitive 
research information, within the bounds of the law. 
 
Adverse Events (AEs) and Serious Adverse Events (SAEs), as defined by the DHHP Office of Human 
Research Protections, will be monitored by the PI (Felton). Any AEs will be recorded by research staff 
on required AE forms and discussed by the research team during regularly scheduled meetings. Per 
regulations, the PI will then prepare a written report for submission to the Henry Ford Health Systems 
(HFHS) IRB and the appropriate NIH program officer. This report will specify all relevant information 
regarding whether these events were expected or unexpected, the severity of the event, a brief 
narrative of the event, and a determination regarding any causal connection between the event and the 
ongoing research study. Any such events will also be included in the annual progress report send to 
NIH. In the unlikely event an SAE were to occur, research staff will alert the PI immediately. 
Subsequent reports to the HFHS IRB and NIH will be completed within 24 hours. The expedited notice will 
be followed by a detailed report regarding the event. 
 
Primary Outcomes: Delay Discounting and Consideration of Future Consequences  
 
Descriptive statistics will be used to characterize the sample. We defined benchmark milestones a priori 
for successful change in our target mechanism (delay discounting): ≥50% of patients participating in the 
intervention demonstrating decreases in delay discounting. Consideration of future consequences will be 
examined using descriptive statistics to evaluate distributional assumptions for parametric statistical tests. 
If appropriate, single-sided paired-samples t-tests with be used given a priori hypotheses regarding the 
direction of the effect. 
 
Secondary Outcomes: Parenting (as measured by a behavioral task and self-report)  
 
Descriptive statistics and distributions will be examined for all secondary outcomes. Parent-child 
interaction tasks were coded for positive and negative parenting behaviors using the Dyadic Parent-Child 
Interaction Coding System. Change in both self-reported and observed positive and negative parenting 
behaviors in will be evaluated using single-sided paired-samples t-tests.  
 

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13. QUALIFICATIONS OF THE INVESTIGATOR(S) 
 
Dr. Felton is an Assistant Scientist at the Henry Ford Health Systems located in Detroit, MI. She earned 
her PhD in child clinical psychology from Vanderbilt University with a minor specialization in quantitative 
methods. Her program of research centers on identifying risk factors for the onset of substance use in 
children and adolescents (e.g., Felton et al., 2015) as well as examining the role of early environmental 
and parenting factors associated with the trajectory of drug and alcohol use over time (e.g., Felton et al., 
2020). She has specific expertise in assessment, research design, and data modeling techniques, 
having served as the PI, Co-I, or statistical consultant on a number of NIH-funded grants and published 
over 65 manuscripts and book chapters on the development of vulnerabilities to mental and behavioral 
health problems and targeted preventative interventions to reduce these risk factors. 
 
14. REFERENCES 
 
Dassen, F. C. M., Houben, K., & Jansen, A. (2015). Time orientation and eating behavior: Unhealthy 
eaters consider immediate consequences, while healthy eaters focus on future health. Appetite, 91, 13–
19. https://doi.org/10.1016/j.appet.2015.03.020 
Felton, J.W., Kofler, M.J., Lopez, C.M., Saunders, B.E., & Kilpatrick, D.G. (2015). The emergence of 
cooccurring adolescent drug use and depressive symptoms: A latent growth modeling approach. 
Development and Psychopathology. 
 
Felton, J.W., Collado, A., Cinader, M., Lejuez, C.W., Chronis-Tuscano, A., & Yi, R. (2020). Exposure to 
maternal depressive symptoms and growth in adolescent substance use: The mediating role of delay 
discounting. Development and Psychopathology. 
 
Felton, J.W., Collado, A., Ingram, K.M., Doran, K., & Yi, R. (2019). Improvement of working memory is a 
mechanism for reductions in delay discounting among mid-age individuals in an urban medically- 
underserved area. Annals of Behavioral Medicine. 
 
Lin, H., & Epstein, L. H. (2014). Living in the moment: Effects of time perspective and emotional 
valence of episodic thinking on delay discounting. Behavioral Neuroscience, 128(1), 12–19. 
https://doi.org/10.1037/a0035705 
Moreland, A.M., Felton, J.F., Hanson, R.F., Jackson, C., & Dumas, J.E. (2016). The relation between 
parenting stress and parenting locus of control: Mechanisms of change in parenting interventions. 
Journal of Child and Family Studies, 25, 2046-2054. 
Snider, S. E., DeHart, W. B., Epstein, L. H., & Bickel, W. K. (2019). Does delay discounting predict 
maladaptive health and financial behaviors in smokers? Health Psychology, 38(1), 21. 
Stein, J. S., Wilson, A. G., Koffarnus, M. N., Daniel, T. O., Epstein, L. H., & Bickel, W. K. (2016). Unstuck 
in time: Episodic future thinking reduces delay discounting and cigarette smoking. 
Psychopharmacology, 233(21), 3771–3778. https://doi.org/10.1007/s00213-016-4410-y