Walk With Me (WWM) for Perinatal Grief
Phase: NA
Conditions: Grief, Traumatic Stress, Usability
Sponsor: Oregon Research Behavioral Intervention Strategies, Inc.

ORI IRB# 00000278 
 
Protocol Version 6/1/2021 
 
Official Title: Walk With Me (WWM) for Perinatal Grief 
 
Principal Investigators: Camille C. Cioffi, Ph.D. and David Smith, Ph.D. 
 
Oregon Research Behavior Interventions Strategies, dba Influents Innovations 
 
Award No. R43 MH126788 
 
Final Version Dated: 6/1/2021 
 
 

STUDY PROTOCOL 
 
Participant Recruitment, Enrollment, and Overall Design 
Recruitment for the 52 parents for the evaluation testing was coordinated in collaboration 
with PeaceHealth staff members who provided potentially eligible parents with a brief 
description of the project and obtained consent to share their information with Influents 
Innovations staff for our research to contact them to provide further information about the study 
two weeks following their loss to mirror the in-app referral process that will occur in phase II. 
Parents that did not give permission for PeaceHealth staff were not contacted by Influents 
Innovations, though they could contact Influents Innovations directly using the contact 
information in a brochure that they received from PeaceHealth. Once PeaceHealth staff received 
permission from a parent for Influents Innovations to contact them, project staff called to further 
explain the details of the project, confirm eligibility requirements and discuss confidentiality. If 
the parent expressed interest in participating, we sent them an electronic informed consent and 
survey to complete intake. We were available by phone or email to answer any questions. 
After consent, parents completed the baseline survey (T1) via the Qualtrics online assessment 
form and then be provided download access to the Walk With Me (WWM) prototype. After 6 
weeks, parents were administered the post-treatment surveys (T2 and T3). This design allowed 
us to evaluate baseline to follow-up change in the proposed study outcomes and acceptability of 
the prototype WWM program. 
We evaluated feasibility and initial eﬃcacy of WWM in a within-subjects pre-post design 
study (pretest, 4- and 8-week posttests [T1-T3]). We provided the mobile-based provider 
component for use by Health Care Providers (HCPs) who worked in our partner hospital.  
 
Walk with Me (WWM) Prototype Intervention Program 
We developed professional training and modules for health care professionals (HCPs) and 
grief processing and healing activities for bereaved parents, via an iterative formative 
development process with stakeholder input. We embedded the core intervention components in 
administrative, provider, and client interfaces which will comprise the protype Walk with Me 
(WWM) intervention. 
 
Measures 
T1, T2, and T3 surveys measured parents’ parenting traumatic stress (Impact of Events Scale-
revised with 22 items), grief intensity (Perinatal Grief Intensity Scale with 12 items), grief 
management self-efficacy (3 items that rate bereaved parents confidence in their ability to cope 
with grief, use knowledge of mindfulness skills to cope, and engage in positive behaviors to help 
coping), care experiences (6 items of experiences of care at the time of loss and follow-up 
appointments after loss), and difficulties with emotional regulation (11 items from the Emotional 
Regulation Scale). The T3 survey also contained measures of parent satisfaction, acceptability, 
and usability of the WWM intervention program. Demographics were collected at T1, and usage 
data measured parents’ usage of WWM. 
 
STATISTICAL ANALYSIS PLAN 
 
Preliminary analyses included a descriptive summary of the sample, summary of 
participation and missing data, and attrition analysis. 

For change in study outcomes, we used mixed effects growth models estimated with full 
information maximum likelihood using PROC MIXED from SAS (Version 9.4). The model 
included a fixed effect of time that was coded in weeks and the pretest assessment was defined as 
a random intercept. The time term is a test of the efficacy of the intervention to produce 
favorable change in the study outcomes.  
 
A critical element of evaluation is the acceptability of the program for the targeted 
population. To address this factor, we provide a descriptive summary parent satisfaction with the 
program, and program use metrics.