A Brief Intervention to Enhance Supportive Parenting and Treatment Engagement Among Families Waiting for Trauma-Focused Services
Phase: NA
Conditions: Parent-Child Relations, Parenting, Child Mental Disorder
Sponsor: Medical University of South Carolina

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PROTOCOL TITLE: 
 
Examine the Feasibility and Acceptability of Project Support 
 
PRINCIPAL INVESTIGATOR: 
Caitlin Rancher 
 
 

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1.0 
Objectives / Specific Aims 
• 
Examine the feasibility and acceptability of delivering Project Support via telehealth. 
Conduct a mixed-methods proof-of-concept pilot trial with n = 30 families waiting 
for trauma-focused services. 
• 
Hypothesis (1) Project Support will be feasible and acceptable as evidenced by 
benchmarks for recruitment, retention at post assessment, engagement, fidelity, and 
program satisfaction.  
• 
Hypothesis (2) participants who receive Project Support will report improvements in 
supportive parenting, parenting self-efficacy, hopefulness, and child mental health 
symptoms. 
2.0 
Background 
Over two-thirds of children experience traumatic events such as child maltreatment, 
violence, or sudden or violent loss. Many of these children sustain significant emotional 
and developmental difficulties including trauma symptoms, aggression, and suicidality. 
Emotional support from a caregiver is theorized to buffer against the effects of trauma; 
however, many caregivers lack the self-efficacy and skills to effectively support their child, 
or struggle to apply these skills during the stressful time following trauma. Unfortunately, 
programs designed for caregivers following child trauma are scarce. Existing interventions 
are lengthy (lasting 8-20 sessions) and result in families placed on long waitlists. This 
proposal asserts the adverse effects of child trauma can be interrupted though a brief 
intervention (the Project Support Positive Parenting Module) that enhances supportive 
parenting – delivered via telehealth to families on waitlists for trauma-focused services.  
The objective is to examine the telehealth delivery of the Project Support Positive 
Parenting Module (Project Support) among families waiting for trauma-focused services. 
Project Support uses didactic instruction to teach caregivers how to listen to and comfort 
their child. In my preliminary work, I found this intervention can be delivered by 
paraprofessionals, improve parenting self-efficacy and emotional support, and increase 
later trauma-focused treatment attendance (Rancher et al., 2023). While it shares some 
features of stepped care models, Project Support is the only brief, empirically-supported 
program designed to enhance parenting and engagement following child trauma. 
Long-term, this research will generate an effective intervention that addresses the needs of 
families affected by trauma, which can be scaled up to address other public health 
epidemics that impede supportive parenting and child development. 
3.0 
Intervention to be studied (if applicable) 
 
This research involves a proof-of-concept pilot trial to examine the feasibility and acceptability of 
delivering the Project Support Positive Parenting module via telehealth to families on the waitlist 
for trauma-focused services. The Project Support Positive Parenting Module is a subset of a 
longer, efficacious parenting intervention, Project Support, that uses didactic, tailored instruction 
to teach caregivers how to attentively listen to and comfort their child (Jouriles et al. 2018, 
Rancher et al., 2021). The core components of the intervention are outlined in Table 1. 
 
 
 

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Table 1. Project Support Positive Parenting Module Components 
Program 
Components 
Short-term 
Objectives 
Midterm 
Objectives 
Long-term 
Goals 
Psychoeducation 
on the importance 
of listening to and 
comforting your 
child 
Increase 
knowledge about 
parent-child 
communication 
Increase 
caregiver’s 
motivation for 
spending time 
listening to 
and 
comforting 
their child 
Improve 
caregiver 
emotional 
support 
 
Handouts and 
discussion of 
“Do’s” and 
“Don’ts” for the 
Listening and 
Comforting skills 
Increase 
knowledge and 
awareness of 
skills 
Increase 
supportive 
and 
responsive 
parenting 
behaviors 
Improve 
parenting 
self-
efficacy 
 
Didactic 
instruction and 
role-play practice 
with service 
provider 
Increase efficacy 
and ability to use 
listening and 
comforting skills 
Increase the 
time and 
frequency the 
caregiver 
spends 
listening to 
and 
comforting 
their child 
Decrease 
child 
adjustment 
problems 
After mastery of 
skills is obtained 
with provider, use 
of skill with child 
Increase efficacy 
and ability to use 
listening and 
comforting skills 
with child 
 
 
 
Caregivers will receive up to four, 60- to 90-minute sessions focused on teaching two parenting 
skills – attentive listening and comforting. Attentive listening involves providing accurate and 
timely responses to show interest and keep the child engaged until they are ready to end the 
conversation. This skill involves both verbal and nonverbal listening behaviors including requests 
for clarification, reflecting what the child is saying, reflecting feelings, and simple verbal 
responses to encourage conversation (e.g., “Interesting!”). Comforting involves using the same 
attentive listening skills when the child is upset or distressed. Effective mastery of the listening 
and comforting skills also requires caregivers to withhold any non-listening or non-comforting 
responses, such as interruptions, accusations, judgements, criticisms, or dismissive gestures. 
 
The program is individually tailored to the caregiver’s parenting abilities: caregivers with stronger 
skills, or those who mastered the skills more quickly, could complete the program in less time 
(i.e., fewer sessions) than those who need more time to master implementation of the skills. 
Service providers educate caregivers about the skills, using handouts to summarize their purpose 
and correct use; then engage in an iterative process of modeling the skills, engaging the caregivers 
in behavioral practice using the skills; and provide stepped, tailored, supportive feedback designed 
to help caregivers gain mastery. Most session time is focused on behavioral practice and feedback, 
with caregivers learning and mastering the skills incrementally through role-plays with the service 
provider (for further refinement and feedback) and the child (for observation and determination of 
mastery). Caregivers are deemed to have met mastery if they can provide at least six appropriate 
listening and/or comforting responses and refrain from providing any non-listening/non-
comforting responses during a 3- to 5- minute interaction. Caregivers who demonstrated mastery 
of the skills are considered to have received the full “dosage” of the intervention. 
 
Previous randomized-controlled trials conducted by the Principal Investigator of this proposed 
research (Rancher, McDonald, Cook, et al., 2023; Rancher, McDonald, Ostner, et al., 2023). have 

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found that Project Support can effectively improve caregiver support, parenting self-efficacy, and 
later engagement in therapy services. Project Support has been delivered by paraprofessionals with 
high fidelity to a range of caregivers, including mothers, fathers, kinship caregivers, and 
grandparents. Project Support has been administered in English, Spanish, and Swedish. This 
current evaluation will examine whether it is feasible and acceptable to deliver Project Support via 
telehealth to families on the waitlist for trauma-focused services. 
 
4.0 
Study Endpoints (if applicable) 
• 
N/A 
 
5.0 
Inclusion and Exclusion Criteria/ Study Population 
• 
Participants will be screened for eligibility during an initial phone call from a 
member of the research team.  
• 
Inclusion Criteria: 
(1) Family is seeking trauma-focused services for their child as measured by their 
placement on the waitlist for services at the National Crime Victims Center; 
(2) Child is between 5 – 12 years old; 
(3) Caregiver agreed to be contacted for volunteer research opportunities; 
(4) Caregiver and child can communicate in either English; 
(5) Child has been living with caregiver for at the last 6 months or longer; 
(6) Family is able to participate in services delivered via telehealth. 
• 
Exclusion Criteria:  
(1) Child or caregiver has a diagnosis that would impair their ability to participate 
in or benefit from services (e.g., traumatic brain injury, developmental 
disability, psychosis); 
(2) Child is in Foster Care or Department of Social Services custody; 
(3) The caregiver is unwilling or unable to give informed consent and/or the child 
is unwilling and unable to give assent. 
• We plan to include children in the present study as we are explicitly interested in 
evaluating a parenting intervention for families of school-aged children on the waitlist 
for trauma-focused services. 
6.0 
Number of Subjects 
Total N = 30 child and caregiver pairs 
7.0 
Setting 
• 
All procedures will take place remotely via telehealth.  
8.0 
Recruitment Methods 
• 
Potential participants will be contacted by phone by a member of the research team.  

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• 
Potential participants will be identified from a review of the waitlist at the trauma 
mental health clinic (e.g., National Crime Victims Center). The waitlist will provide 
initial information on child age and whether the family was willing to be contacted 
for volunteer research opportunities.  
• 
Research team members will continuously monitor the waitlist for potential 
participants.  
• 
Research team members will verbally describe the research study during a phone call 
with potential participants. This recruitment script and phone screen are attached in 
the eIRB application.  
9.0 
Consent Process 
We will be obtaining informed consent and assent. 
• 
We will collect electronic consent and assent remotely (e.g., at the subject’s home or 
another convenient venue) since all study procedures will take place remotely.  
• 
The consent and assent process will take place in a private setting. 
• 
Adult subjects will be given the opportunity to read the consent and ask questions 
before signing the consent.  
• 
The study involves children between ages 5-12 years old, however, consistent with 
HRPP Section 8.5 – Research Involve Children, only child subjects aged 12 years or 
older will complete assent procedures. Children ages 12 years or older will have the 
assent form read aloud to them and will be given the opportunity to ask questions 
before signing the assent form. 
• 
Parental permission will be obtained by first having each caregiver complete the 
consent process. Only for those adult caregivers who provide consent will we ask 
their child to provide assent.  
• 
Children in the current study will not reach the age of majority during the study, so 
they will not complete any re-consent procedures.  
• 
Participants will provide an electronic signature using the REDCap eConsent feature. 
A member of the research team is a NEXUS Research Coordinator (Emma McLeod) 
at MUSC SCTR and will facilitate accurate use of this eConsent feature. 
• 
Participants will be provided a copy of the signed consent via email. Adult caregivers 
will also receive a copy of their child’s assent via email. 
 
10.0 Study Design / Methods 
• 
All participants (caregivers and children) will complete a baseline survey assessment 
on demographics, parenting behaviors, and mental health symptoms (surveys are 
attached in the eIRB application.  
• 
All caregivers will then receive the Project Support intervention (described above in 
“Intervention to be Studied”). Briefly this entails up to four 60-minute live sessions 
focused on teaching caregivers how to listen to and comfort their child. Participants 
will receive one-on-one didactic instruction and feedback on their real-time use of the 
skills in role-plays with a treatment provider. The caregiver and provider will meet 
on a videoconferencing platform (e.g., MUSC COM licensed Zoom). In the role-

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plays the provider first demonstrates how to use the skill in a brief example of typical 
situations in which the skill could be used. In these examples the caregiver takes on 
the role of their child and the provider takes on the role of the caregiver. 
Subsequently the caregiver and provider switch roles so the caregiver has an 
opportunity to practice executing the skill. The provider helps the caregiver process 
their experience of each role-play and provides real-time, targeted feedback to help 
the caregiver develop their ability to use the skills.  
• 
Project Support sessions will be recorded to facilitate coding of treatment fidelity and 
to provide ongoing training in group supervision. 
• 
Approximately 4-6 weeks after the baseline assessment, all participants (caregivers 
and children) will complete a post-test survey assessment. This will also include 
measures of service satisfaction and acceptability of the Project Support intervention.  
• 
Both the baseline and post-test survey assessments should take less than 30 minutes 
to complete.  
• 
We anticipate participation time will be up to 6 weeks, including the baseline 
assessment, up to four Project Support sessions, and the post-test assessment. 
Participating in this research study will not delay or impact scheduling the trauma-
focused treatment. We will closely monitor the waitlist to note when intakes are 
scheduled, so that study participation will be completed by the onset of clinical 
services. Part of our research questions include the feasibility of completing the 
intervention during the time families are waiting for services, so we will closely track 
the number of sessions families are able to complete during that time. Over the last 2 
years, families spend, on average, 12-15 weeks on the waitlist.  
• 
All services and data collection will take place remotely, via telehealth and a secure 
web-based platform. Specifically, Project Support intervention sessions will be held 
using a HIPAA-compliant videoconferencing platform (e.g., MUSC COM licensed 
Zoom). Surveys will be administered using REDCap survey software. 
• 
Caregivers will be invited to complete the survey assessments independently. 
Research staff will be available to read items aloud via video conferencing or phone 
to ensure comprehension and attention. Research staff will read items aloud to child 
participants. 
• 
Participant flow through the study is described in Figure 1. 

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11.0 Specimen Collection and Banking (if applicable) 
N/A 
12.0 Data Management  
• The aim of this pilot study is to determine feasibility and acceptability; therefore, 
sample size was determined for pragmatic reasons as advocated by Hertzog (2008). 
With 30 participants, I will be able to estimate proportions with a 95% Confidence 
Interval of (.02, .28) and (.14, .46) for values of the true population proportion (p) of 
0.15 and 0.30, respectively (Hertzog, 2008). I used Kraemer’s guidelines (Kraemer, 
2010) to identify appropriate benchmarks for dissemination feasibility: 
▪ Recruitment: Proportion of caregivers who agree to participate relative 
to the number approached. I will consider it successful if participation 
is > 60% of approached families. 
▪ Retention: Proportion of participants who complete both assessments 
vs. only the baseline assessment. I will consider it successful if > 70% 
of participants are retained for the post-test assessment.  
▪ Engagement: Participation in the Project Support treatment sessions. I 
will consider it successful if > 75% of participants attend 1+ treatment 
session. 
• To examine trends in supportive parenting, parenting self-efficacy, hopefulness, and 
child mental health symptoms I will use multilevel modeling (MLM). Consistent with 
an intent-to-treat approach, MLM includes all participants, regardless of missing data. 
Further MLM can be used in samples as small as 10 participants and still produce 
unbiased coefficient estimates (Maas & Hox, 2005). I will conduct separate analyses 
for each of the outcome variables and examine the effect of time – the change in 
outcome from baseline to post-test – as a preliminary test of intervention effect.  
• All data (Project Support sessions and survey data) will be stored via a password 
protected secure server maintained by MUSC for a minimum of six years, per MUSC 
Baseline Assessment 
Project Support 
Post-test  Assessment 
4 to 6 weeks 
Figure 1. Participant Flow Through Study 
Placed on waitlist for  
trauma-focused services 
Begin trauma-focused services 

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policy. Only the investigators associated with this study will have access to study 
information. 
 
13.0 Provisions to Monitor the Data to Ensure the Safety of Subjects (if applicable) 
The present study was funded by NICHD. This section is based on the recommendations in 
NICHD’s “Data and Safety Monitoring (DSM) Policies for Extramural Clinical Trials and 
Clinical Research.” (https://www.nichd.nih.gov/sites/default/files/inline-
files/NICHD_DSM_Policy_2020.pdf).  
Overall Summary 
The purpose of this study is to examine the telehealth delivery of a brief parenting 
intervention (Project Support) for caregivers on the waitlist for trauma-focused services for 
their child. I will conduct a proof-of-concept pilot trial to examine the feasibility and 
acceptability of the intervention with n = 30 caregivers. The sample will be recruited from 
agencies providing services to children exposed to trauma (e.g., MUSC National Crime 
Victims Center). 
The Principal Investigator (PI), Dr. Rancher, will be responsible for monitoring the safety 
and efficacy of this study, executing the Data and Safety Monitoring (DSM) plan, and 
complying with the reporting requirements. Dr. Rancher will provide a summary of the 
DSM report to NICHD on an annual basis as part of the progress report. The DSM report 
will include the participants’ sociodemographic characteristics, expected versus actual 
recruitment rates, study retention rates, any quality assurance or regulatory issues that 
occurred during the past year, summary of adverse events, serious adverse events, 
unanticipated problems, and any actions or changes with respect to the protocol. The DSM 
report to NICHD will also include, when available, the results of any data analysis 
conducted. 
Data monitoring plan 
All services and data collection will take place via telehealth and a HIPAA-compliant 
secure web-based platform (i.e., RedCap). Participant data will only be identified with a 
study ID. The codes that link the name of the participant and the study ID will be kept 
confidential by the Principal Investigator in a secured cabinet. SPSS software will be used 
to analyze the data. The quality of the data will be monitored once per month. Data quality 
will be monitored by random inspection of the data files by a research assistant and any 
problems detected will be discussed with the PI.  
Safety monitoring plan 
Potential participants will complete a phone screen to determine their eligibility and safety 
of their participation in this study. History of suicidal ideation or suicide attempts, and 
other suicidal risk factors, including suicidal ideation, intent, and plan will be carefully 
assessed and monitored through the study. The PI will be contacted immediately regarding 
clients who are at risk to commit suicide to aid in safety assessment and will be offered 
additional treatment (e.g., hospitalization) as needed and appropriate.  
All adverse events (AEs) will be reported to the MUSC Institutional Review Board (IRB) 
and NIH within 10 working days. AEs are reportable if they are unexpected AND related 
or possibly related to study participation AND serious or more prevalent than expected. 
The IRB definition of unexpected is that the AE is not identified in nature, severity, or 
frequency in the current proposal, informed consent, or with other current risk information. 

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The definition of related is that there is a reasonable possibility that the adverse event may 
have been caused by the study device, drug, or intervention. Serious adverse events (SAEs) 
will be reported within 24 hours. SAEs are defined as any event associated with the 
subject’s participation in research that meets any of the following criteria: death, a life-
threatening event, requires or prolongs inpatient hospitalization, persistent or significant 
disability/incapacity, or a congenital anomaly or birth defect. Important medial events that 
may not result in death, be life-threatening or require hospitalization may be considered a 
SAE when, based upon appropriate medical judgement, they may jeopardize the subject 
and may require medical or surgical intervention to prevent one of the outcomes listed in 
this definition.  
Any SAE, whether or not related to study intervention, will be reported to the MUSC IRB 
and NIH. The initial SAE report will be followed by submission of a completed SAE 
report to both institutions. In the event that a client either withdraws from the study or the 
investigator decides to discontinue a patient due to SAE, the client will be monitored by 
the investigators via ongoing status assessment until 1) a resolution is reached i.e., the 
problem requiring hospitalization has resolved or stabilized with no further changes 
expected 2) the SAE is determined to be clearly unrelated to the study intervention, or 3) 
the SAE results in death. Outcome of SAEs will be periodically reported to NIH. A 
summary of the SAEs that occurred during the previous year will be included in the annual 
progress report to NIH. 
All research staff involved with adverse event reporting will receive training including 
identification, evaluation, and documentation and reporting. All research staff will identify 
any potential AEs or Unanticipated Problems (UPs) during the course of the study from 
self-report and interview data and administration of assessments and the brief intervention. 
This information will be reported to the PI (Dr. Rancher), all mentors and co-investigators, 
the MUSC IRB, the NICHD Program Officer, and the Data and Safety Monitoring Board 
Members.  
Data and Safety Monitoring Board (DSMB)  
We have recruited a DSMB to monitor overall participant safety, the rate and severity of 
adverse events, the progress of the study, and to review procedures for maintaining the 
confidentiality of data, the assent and consent process for all participants, the quality of 
data collection, and data management and analyses. Frequency of meetings of the DSMB 
will be determined by recruitment milestones (e.g., after 20% of participants have been 
recruited, etc.), and will follow each SAE report, but meetings will occur no less than once 
per year. The purpose of these meetings will be to review study progress, data quality, and 
participant safety. DSMB members include an array of disciplinary backgrounds (e.g., 
clinical researchers, statisticians) that are not directly involved in the project.  
Members include: 
◼ Rochelle Hanson, PhD, Professor at the MUSC National Crime Victims Center has 
extensive experience with the population of interest and clinical research among 
families who have experienced trauma.  
◼ Rosmary Ros-Demarize, PhD, Assistant Professor at MUSC Developmental-
Behavioral Pediatrics has expertise in parenting interventions, telehealth service 
delivery, and implementation science. 

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◼ Elizabeth Baumler, PhD, Director of Biostatistics for the Center of Violence 
Prevention and Associate Professor at UT Health has extensive expertise in design 
and analysis of clinical trials.  
Data will be presented in a blinded manner during the open sessions of the DSMB. At 
DSMB meetings, data and discussion are confidential. Participant identities will not be 
known to the DSMB members. 
Conflict of Interest for DSMB’s 
DSMB members will have no direct involvement with the study investigators or 
intervention (e.g., no portion of their effort will be covered by the study). Each DSMB 
member will sign a Conflict of Interest statement which includes current affiliations (if 
any) with pharmaceutical and biotechnology companies (e.g., stockholder, consultant), and 
any other relationship that could be perceived as a conflict of interest related to the study 
and/or associated with commercial interests pertinent to study objectives.  
14.0 Withdrawal of Subjects (if applicable) 
• 
N/A 
15.0 Risks to Subjects 
• 
Although not a direct component of our study, participants may feel distress related 
to the trauma experience and their referral to the trauma mental health clinic. 
• 
Breaches of confidentiality are a concern with Internet-based components of any 
study. For example, it is possible that other people could overhear the participants’ 
intervention sessions with a treatment provider. However, such risks are minimized 
by procedures such as informing the participant that it is possible to reschedule at a 
more convenient time or telling the participant to take steps to insure their privacy 
(e.g., private location, use of headphones).  
• 
Survey assessments of psychological symptoms and history of traumatic event 
exposure may cause participants to feel small to moderate amounts of distress. 
16.0 Potential Benefits to Subjects or Others 
• 
Caregivers and children will directly receive the benefit of an evidence-based 
parenting intervention, Project Support, that has been found to increase emotional 
support, parenting self-efficacy, and reduce child distress. Caregivers will receive 
the intervention at no cost. 
17.0 Sharing of Results with Subjects 
No study results will be shared with participants or others.  
 
18.0 Drugs or Devices (if applicable)  
• 
N/A 
References 
Hertzog, M. A. (2008). Considerations in determining sample size for pilot studies. Research in 
Nursing & Health, 31(2), 180-191. 
 

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Jouriles, E. N., Rosenfield, D., McDonald, R., Vu, N. L., Rancher, C., & Mueller, V. (2018). 
Children exposed to intimate partner violence: Conduct problems, interventions, and partner 
contact with the child. Journal of Clinical Child and Adolescent Psychology, 47(3), 397-409. doi: 
10.1080/15374416.2016.1163706 
 
Kraemer, H. (2010). Randomized clinical trial design: 50 years of learning from mistakes. New 
Research Approaches for Mental Health Interventions, Boca Raton, FL. 
 
Maas, C. J., & Hox, J. J. (2005). Sufficient sample sizes for multilevel 
modeling. Methodology, 1(3), 86-92. 
 
Rancher, C., McDonald, R., Cook, K., & Jouriles, E. N. (2023). Randomized controlled pilot trial: 
Project Support Positive Parenting Module following sexual abuse. Research on Social Work 
Practice, 0(0), 1-12. doi: 10.1177/10497315231212195 
 
Rancher, C., McDonald, R., Ostner, S. G., & Jouriles E. N. (2023). A randomized controlled pilot 
study of the Project Support Positive Parenting Module. Research on Social Work Practice, 34(2), 
132-143. doi: 10.1177/10497315231159049 
 
Rancher, C., McDonald, R., Draxler, H., & Jouriles, E. N. (2021). Working with families and 
children exposed to intimate partner violence. In J.L. Allen, D. J. Hawes, & C. J. Essau (Eds.), 
Family-Based Intervention for Child and Adolescent Mental Health: A Core Competencies 
Approach. Cambridge, UK: Cambridge University Press.