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\begin{document}

\title{Randomized Controlled Trial to Prevent Postpartum Depression: An Infant
Carrier Interventio}



\author[1]{Emily E. Little}%
\author[2]{Lisa Bain}%
\author[3]{Jennifer Hahn-Holbrook}%
\affil[1]{Nurturely 56 E 15th Ave Eugene OR 97401}%
\affil[2]{Global Communities}%
\affil[3]{University of California Merced}%


\vspace{-1em}



  
  \date{May 23, 2024}


\begingroup
\let\center\flushleft
\let\endcenter\endflushleft
\maketitle
\endgroup





\selectlanguage{english}
\begin{abstract}
\subsection*{}\label{section}

There is a need for effective interventions to reduce symptomatology of
postpartum depression. The objective of this study was to test whether
providing an ergonomic infant carrier would reduce postpartum depression
symptomatology.

\subsubsection*{Methods}\label{methods}

A randomized two-arm, parallel-group trial with 100 participants was
conducted between February 2018 and June 2019 in a low-income community.
At 30-weeks' gestation, 50 participants were randomly assigned to
receive an ergonomic infant carrier and instructions on proper use
(intervention group), and 50 participants were assigned to a waitlist
(control group). Participants tracked the extent of their infant carrier
use and completed the Edinburgh Postpartum Depression Scale (EPDS) to
assess postpartum depression symptomatology at 6-weeks postpartum.

\subsubsection*{Results}\label{results}

Participants in the intervention group reported using an infant carrier
significantly more often than the control group
(\selectlanguage{greek}β\selectlanguage{english}\,=\,2.69,~\emph{SE}\,=\,0.347,~\emph{p}\,\textless{}\,.001,
95\,\%~\emph{CI}\,=\,2.08--3.41). The intervention group reported fewer
depressive symptoms at 6-weeks postpartum than the control group
(\selectlanguage{greek}β\selectlanguage{english}\,=\,-0.541,~\emph{p}\,=\,.042).

\subsubsection*{Limitations}\label{limitations}

The sample size was relatively small and thus our results may not be
generalizable to the general population.

\subsubsection*{Conclusion}\label{conclusion}

Infant carrying may be a cost-effective intervention to reduce
postpartum depression symptomatology. Large-scale studies are warranted
to further examine the efficacy and cost-effectiveness of providing
carriers as an intervention to reduce postpartum depression
symptomatology.%
\end{abstract}%



\sloppy




\textbf{Randomized Controlled Trial to Prevent Postpartum Depression: An
Infant Carrier Intervention}

Emily E. Little\textsuperscript{a}, PhD, Lisa Bain\textsuperscript{b},
MPH, Jennifer Hahn-Holbrook\textsuperscript{c}, PhD

\textbf{Affiliations:}

\textsuperscript{a} Nurturely, 56 E 15th Ave, Eugene, OR 97401

\textsuperscript{b}Global Communities, 5151 Murphy Canyon Rd, San Diego,
CA 92123

\textsuperscript{c} University of California Merced, Department of
Psychological Sciences, 5200 North Lake Rd.

Merced, CA 95343

\textbf{Corresponding Author:} Emily Little; Executive Director;
Nurturely,

56 E 15th Ave, Eugene, OR 97401; Phone: 707-391-7477;
emily@nurturely.org

\textbf{Short title:} Infant Carriers and Postpartum Depression



\par\null

\subsection*{Introduction}\label{introduction}

Postpartum depression is the most common complication of childbirth,
impacting approximately 19\,\% of postpartum mothers globally
(Fish-Williamson and Hahn-Holbrook, 2023). Postpartum depression is a
major public health problem because it raises the risk of parental
suicide (Miranda and Patel, 2005; Oates, 2003) and can impair parenting
behavior, adversely impacting the cognitive and behavioral development
of children (Field, 2010; Paulson et al., 2006). Given the widespread
adverse consequences of postpartum depression, significant resources
have been devoted to identifying interventions that may help to prevent
postpartum depression (Dennis and Dowswell, 2013; Werner et al., 2015).
One previously identified target of prevention is parent-infant
skin-to-skin contact directly after birth, which has been found to
reduce postpartum depression symptoms in parents of preterm or low
birthweight infants (Scime et al., 2019). However, no research has
examined the effect of infant carrying on postpartum depression
symptomatology in healthy parent-infant dyads.

Parent-infant skin-to-skin contact with preterm and low birthweight
neonates is a well-established intervention that can improve parental
mood by reducing stress (Tessier et al., 1998), enhancing anxiety
regulation (Cong et al., 2021), and reducing postpartum depression
symptomatology (Feldman et al., 2010). Physiologically, skin-to-skin
contact can trigger the release of the bonding hormone oxytocin (Carter
et al., 2007; Cong et al., 2015; M\selectlanguage{ngerman}örelius et al., 2015), and decreased
levels of the stress hormone cortisol (Takahashi et al., 2011), both of
which have been implicated in reduced postpartum depression risk (Yim et
al., 2015). Behaviorally, skin-to-skin contact between parents and
infants reduces infant crying (Erlandsson et al., 2007), supports
breastfeeding (Moore and Anderson, 2007), and bolsters parent-infant
bonding (Tessier et al., 1998), all of which may reduce postpartum
depression risk (Alimi et al., 2022; Hahn-Holbrook et al., 2017; Shovers
et al., 2021). Although less is known about how parent-infant physical
contact outside of clinical skin-to-skin interventions may prevent
postpartum depression symptomatology, recent studies have shown that
infant carrying -- by attaching the infant to the caregiver's body with
a textile wrap or semi-structured carrier, also known as ``babywearing''
-- shapes some of the same outcomes as direct skin-to-skin contact.

A recent review (Grisham et al., 2023) highlighted a small but growing
body of work connecting infant carrying with postpartum mental health
and related outcomes. For example, a correlational study found that
mothers who self-reported using an infant carrier more often reported
less repetitive negative thinking and more positive mental health while
infant carrying (Schoppmann et al., 2023). Although no randomized
controlled trials have assessed how infant carrying shapes postpartum
mental health specifically, a handful of randomized controlled trials
showed an effect of infant carrying on potentially related postpartum
outcomes, including secure attachment (Anisfeld et al., 1990; Williams
and Turner, 2020a) and parental responsiveness during the still-face
task (Williams, 2020). Similarly, from data collected as part of the
current randomized controlled trial, our group showed that mothers
randomly assigned to receive an ergonomic infant carrier in pregnancy
were significantly more likely to be breastfeeding at six months
compared to mothers in the waitlist control condition (Little et al.,
2021). Though this literature is still fairly sparse, the emerging body
of work results suggest that infant carrying could have psychological
and physiological benefits related to postpartum mental health. Thus
far, this hypothesis has not been directly tested.

We examined whether a randomized controlled intervention with infant
carriers would result in decreased postpartum depression symptomatology
in the first six weeks after birth. We predicted that the infant
carrying intervention would reduce postpartum depression symptomatology
at 6-weeks postpartum compared to a waitlist control condition. We also
predicted an inverse dose-response relationship between infant carrier
use and postpartum depression, with more hours of carrier use being
associated with fewer postpartum depression symptoms.

\subsection*{Section snippets}\label{section-snippets}

\subsection*{Methods}\label{methods}

A randomized two-arm, parallel group trial
(\href{https://clinicaltrials.gov/}{clinicaltrials.gov}~id:~\href{https://clinicaltrials.gov/show/NCT04376021}{NCT04376021})
was conducted between February 2018 (first participant enrolled February
7, 2018) and June 2019 to study the effects of an infant career
intervention on postpartum depression symptomatology, breastfeeding
rates, and parent-infant bonding in collaboration with a home visiting
program for perinatal parents in a primarily Latinx, income-constrained
urban community. The breastfeeding results are reported previously by~

\subsection*{Participant
characteristics}\label{participant-characteristics}

A total of 238 participants were assessed for eligibility, with 138
excluded and 100 randomized during pregnancy into the intervention
(\emph{n}\,=\,50) or waitlist control (\emph{n}\,=\,50) conditions (see
the Consort Diagram in Fig. 1).

Demographic characteristics are presented in Table 1, with all
participants identifying as female (hereafter referred to as mothers).
Mothers in the intervention and control groups had similar intentions to
breastfeed and had similar demographic and health characteristics
except~

\subsection*{Main findings}\label{main-findings}

In experimentally testing the efficacy of an infant carrier intervention
to reduce postpartum depression symptomatology, we found that
participants randomly assigned to receive an infant carrier reported
significantly fewer depressive symptoms at 6-weeks postpartum than
participants in the waitlist control group. Further, there was good
uptake of the carrier intervention (79.5\,\% of participants in
intervention groups used their carriers in the first 6-weeks
postpartum), although there was no

\subsection*{Conclusion}\label{conclusion}

Postpartum depression and other mood disorders cost an estimated \$14.2
billion per year in the US (Luca et al., 2019) and have health
consequences for both the birthing parent and the child (Slomian et al.,
2019). Our research demonstrates that providing parents with an
ergonomic infant carrier may be an easy and effective intervention to
decrease depressive symptomatology during the high-risk period of the
first weeks after birth. To understand the generalizability of this
intervention, we

\subsection*{CRediT authorship contribution
statement}\label{credit-authorship-contribution-statement}

Dr. Little led the study design, data collection, and manuscript
preparation. Lisa Bain helped with intervention implementation plan,
participant recruitment, and data collection efforts. Dr. Hahn-Holbrook
helped to design the study, conducted all analyses, and reviewed and
revised the manuscript. All authors approved the final manuscript as
submitted and agree to be accountable for all aspects of the work.

\subsection*{Details of ethics
approval}\label{details-of-ethics-approval}

All procedures received ethics approval from the relevant ethics
committee responsible for human experimentation: Institutional Review
Board for Project Concern International, now Global Communities
(approved protocol \# 28).

\subsection*{Funding}\label{funding}

ErgoBaby donated all infant carriers used in this study but did not
participate in any part of the research.

\subsection*{Uncited references}\label{uncited-references}

Little et al., 2018

Pisacane et al., 2012

\subsection*{Conflict of interest}\label{conflict-of-interest}

ErgoBaby donated all infant carriers used in this study but did not
participate in any part of the research. The authors have no other
financial, personal, political, intellectual, or religious relationships
relevant to this article to disclose.

\subsection*{Acknowledgments}\label{acknowledgments}

The study protocol was developed in partnership with California Border
Healthy Start (CBHS), a program of Project Concern International (now
Global Communities). The program began operation in 2007 and is funded
through the National Healthy Start initiative, which aims to address
disparities in birth outcomes. The authors appreciate the support of
CBHS staff (especially Alejandra Leon) in helping with the protocol
design; recruitment and retention of study participants; and the
provision of

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There are more references available in the full text version of this
article.













\textbf{}

\textbf{Table 1} \emph{Baseline Participant Characteristics}\selectlanguage{english}
\begin{longtable}[]{@{}lllll@{}}
\toprule
& Control & Intervention & \emph{Exp(B)} & \emph{p-value}\tabularnewline
\textbf{Age, mean (\emph{SD})} & \textbf{28.83 (5.65)} & \textbf{24.25
(6.21)} & \textbf{.881} & \textbf{.003}\tabularnewline
Breastfeeding intentions & 11.05 (4.66) & 11.33 (4.60) & 1.013 &
.791\tabularnewline
\textbf{English Language Proficiency} & \textbf{2.39 (1.13)} &
\textbf{1.44 (.84)} & \textbf{.399} & \textbf{.000}\tabularnewline
Latina & 92\% & 97\% & 3.364 & .304\tabularnewline
High School Graduate & 64\% & 70\% & 1.319 & .572\tabularnewline
US Born & 39\% & 53\% & 1.737 & .864\tabularnewline
\textbf{Married or Living in Union} & \textbf{79\%} & \textbf{57\%} &
\textbf{.346} & \textbf{.051}\tabularnewline
Currently Employed & 10\% & 15\% & 1.607 & .542\tabularnewline
\textbf{Preterm} & \textbf{0\%} & \textbf{10\%} & \textbf{21.203} &
\textbf{.001}\tabularnewline
Primiparous & 82\% & 67\% & 2.333 & .133\tabularnewline
\emph{Note: Binomial logistic regression was used in all analyses to
predict differences in demographics across study condition (0 = control;
1 = intervention). Each demographic factor was compared across
conditions individually, in separate models. Any variable that differed
between groups at p \textless{} .10 was included as a potentially
confounding variable in follow-up models testing for the effect of the
intervention (highlighted in bold). Exp(B) is a odds ratio, with 1
meaning no difference, values under 1 meaning slightly less likely, and
values over 1 meaning more likely to occur in the intervention compared
to control group. English language proficiency scores ranged from 1 to
4, with 4 being completely English proficient and 1 being no English
proficiency.} & \emph{Note: Binomial logistic regression was used in all
analyses to predict differences in demographics across study condition
(0 = control; 1 = intervention). Each demographic factor was compared
across conditions individually, in separate models. Any variable that
differed between groups at p \textless{} .10 was included as a
potentially confounding variable in follow-up models testing for the
effect of the intervention (highlighted in bold). Exp(B) is a odds
ratio, with 1 meaning no difference, values under 1 meaning slightly
less likely, and values over 1 meaning more likely to occur in the
intervention compared to control group. English language proficiency
scores ranged from 1 to 4, with 4 being completely English proficient
and 1 being no English proficiency.} & \emph{Note: Binomial logistic
regression was used in all analyses to predict differences in
demographics across study condition (0 = control; 1 = intervention).
Each demographic factor was compared across conditions individually, in
separate models. Any variable that differed between groups at p
\textless{} .10 was included as a potentially confounding variable in
follow-up models testing for the effect of the intervention (highlighted
in bold). Exp(B) is a odds ratio, with 1 meaning no difference, values
under 1 meaning slightly less likely, and values over 1 meaning more
likely to occur in the intervention compared to control group. English
language proficiency scores ranged from 1 to 4, with 4 being completely
English proficient and 1 being no English proficiency.} & \emph{Note:
Binomial logistic regression was used in all analyses to predict
differences in demographics across study condition (0 = control; 1 =
intervention). Each demographic factor was compared across conditions
individually, in separate models. Any variable that differed between
groups at p \textless{} .10 was included as a potentially confounding
variable in follow-up models testing for the effect of the intervention
(highlighted in bold). Exp(B) is a odds ratio, with 1 meaning no
difference, values under 1 meaning slightly less likely, and values over
1 meaning more likely to occur in the intervention compared to control
group. English language proficiency scores ranged from 1 to 4, with 4
being completely English proficient and 1 being no English proficiency.}
& \emph{Note: Binomial logistic regression was used in all analyses to
predict differences in demographics across study condition (0 = control;
1 = intervention). Each demographic factor was compared across
conditions individually, in separate models. Any variable that differed
between groups at p \textless{} .10 was included as a potentially
confounding variable in follow-up models testing for the effect of the
intervention (highlighted in bold). Exp(B) is a odds ratio, with 1
meaning no difference, values under 1 meaning slightly less likely, and
values over 1 meaning more likely to occur in the intervention compared
to control group. English language proficiency scores ranged from 1 to
4, with 4 being completely English proficient and 1 being no English
proficiency.}\tabularnewline
\bottomrule
\end{longtable}



\textbf{Table 2}

\emph{Step-Wise Linear Regression Model Testing for Differences in
Postpartum Depressive Symptomology Between Study Condition}\selectlanguage{english}
\begin{longtable}[]{@{}llllll@{}}
\toprule
& B & SE & \emph{P value} & \emph{95\% CI} & \emph{95\%
CI}\tabularnewline
\textbf{Model 1} & & & & &\tabularnewline
Study Condition & -.477 & .233 & .046 & .046 & -.933 to
-.012\tabularnewline
\textbf{Model 2} & & & & &\tabularnewline
Study Condition & -.541 & .263 & .042 & .042 & -1.048 to
-.016\tabularnewline
Maternal Age & .034 & .027 & .212 & .212 & -.018 to .086\tabularnewline
English Language Proficiency & -.223 & .138 & .110 & .110 & -.501 to
.041\tabularnewline
Preterm Delivery & -.614 & .299 & .042 & .042 & -1.164 to
-.002\tabularnewline
Married or Living in Union & \textbf{-}.146 & .256 & .570 & .570 & -.666
to .364\tabularnewline
\emph{Note: Step-Wise linear regression model was used with
bootstrapping across 5000 samples to improve estimate accuracy given the
small sample size. Model 1 gives the estimates for condition alone (0 =
control, 1 = intervention) on EPDS scores at 6 weeks (log-transformed to
improve normal distribution and z-scored to ease model interpretation).
Model 2 gives the estimated impact of study conditions after
statistically adjusting for factors that differed across conditions.} &
\emph{Note: Step-Wise linear regression model was used with
bootstrapping across 5000 samples to improve estimate accuracy given the
small sample size. Model 1 gives the estimates for condition alone (0 =
control, 1 = intervention) on EPDS scores at 6 weeks (log-transformed to
improve normal distribution and z-scored to ease model interpretation).
Model 2 gives the estimated impact of study conditions after
statistically adjusting for factors that differed across conditions.} &
\emph{Note: Step-Wise linear regression model was used with
bootstrapping across 5000 samples to improve estimate accuracy given the
small sample size. Model 1 gives the estimates for condition alone (0 =
control, 1 = intervention) on EPDS scores at 6 weeks (log-transformed to
improve normal distribution and z-scored to ease model interpretation).
Model 2 gives the estimated impact of study conditions after
statistically adjusting for factors that differed across conditions.} &
\emph{Note: Step-Wise linear regression model was used with
bootstrapping across 5000 samples to improve estimate accuracy given the
small sample size. Model 1 gives the estimates for condition alone (0 =
control, 1 = intervention) on EPDS scores at 6 weeks (log-transformed to
improve normal distribution and z-scored to ease model interpretation).
Model 2 gives the estimated impact of study conditions after
statistically adjusting for factors that differed across conditions.} &
\emph{Note: Step-Wise linear regression model was used with
bootstrapping across 5000 samples to improve estimate accuracy given the
small sample size. Model 1 gives the estimates for condition alone (0 =
control, 1 = intervention) on EPDS scores at 6 weeks (log-transformed to
improve normal distribution and z-scored to ease model interpretation).
Model 2 gives the estimated impact of study conditions after
statistically adjusting for factors that differed across conditions.} &
\emph{Note: Step-Wise linear regression model was used with
bootstrapping across 5000 samples to improve estimate accuracy given the
small sample size. Model 1 gives the estimates for condition alone (0 =
control, 1 = intervention) on EPDS scores at 6 weeks (log-transformed to
improve normal distribution and z-scored to ease model interpretation).
Model 2 gives the estimated impact of study conditions after
statistically adjusting for factors that differed across
conditions.}\tabularnewline
\bottomrule
\end{longtable}

\selectlanguage{english}
\FloatBarrier
\end{document}

