Premature Birth Clinical Trial
Official title:
Improving Outcomes of LBW Premature Infants and Parents
The purpose of this study is to determine whether beginning an enriched
educational/behavioral program for parents of premature infants, very early in the Neonatal
Intensive Care Unit (NICU) stay, and lasting until the child is 3 years old, has beneficial
results for both the parents and their infants.
The hospital phase of the program gives parents an understanding of what to expect in the
NICU environment; physical characteristics and needs of their premature baby; and how and
when to best support their infant's development during this time. The information given
during the home phase of the program continues with information specific to the growth and
development and the effective parenting of an infant/toddler who has been born prematurely.
It is believed that this information will help decrease parents' stress, anxiety and
depression levels that can be related to giving birth to a premature infant. It is also
expected that it will strengthen the mother's and father's ability to parent their premature
child in a way that will help support their child's brain development and learning ability
and to also decrease negative behaviors as the child grows.
The incidence of premature and low birthweight (LBW) births continues to climb in the U.S.
despite increased efforts to prevent it. Interventions to enhance coping in parents of
infants in an attempt to improve both parent and child outcomes have not kept pace with the
rapid technological advances to sustain survival for these medically compromised infants.
Consequently, there is an urgent need to develop and evaluate coping interventions for
parents of LBW premature infants in order to facilitate effective clinical practice
strategies that are empirically based.
The primary objective for this study is to evaluate the short- and long-term effects of a
theoretically-driven intervention program (COPE: Creating Opportunities for Parent
Empowerment) on the process and outcomes of mothers and fathers/significant others' (SOs)
coping with a LBW premature infant and infant developmental outcomes. The secondary
objectives are to:
- Explore how the coping process and outcomes of mothers and fathers/significant others
together contribute to the outcomes of LBW premature infants;
- Determine the cost-effectiveness of the COPE program; and
- Explore what factors moderate the effects of the intervention (e.g., family structure,
SES, birthweight, disability, and infant temperament).
In this randomized clinical trial, the investigators are testing the following hypotheses
separately for mothers and for fathers/significant others:
- Mothers/fathers who receive the COPE program will report less anxiety, depression, and
stress related to the NICU environment than mothers/fathers who receive the comparison
program;
- Mothers/fathers who receive the COPE program will demonstrate a higher quality of
parenting during hospitalization than mothers/fathers who receive the comparison
program;
- Mothers/fathers who receive the COPE program will report less anxiety and depression
following hospitalization than mothers/fathers who receive the comparison program;
- Mothers/fathers who receive the COPE program will perceive their children as less
vulnerable than mothers/fathers who receive the comparison program;
- Fathers who receive the COPE program will report greater involvement in their infants'
lives (average time spent with infant per week) than fathers who receive the comparison
program;
- Infants of mothers/fathers who receive the COPE program will have greater cognitive
development than infants of mothers/fathers in the comparison program;
- Children of mothers/fathers in the COPE program will have less negative behaviors at 2
years corrected age than children of mothers/fathers in the comparison program;
- The proposed model to explain the effects of the COPE program on the process and
outcomes of parental coping and infant outcomes will be supported for mothers and for
fathers.
In addition, the following study questions will be answered:
- How do parental beliefs and coping outcomes of both mothers and fathers together
contribute to the outcomes of LBW premature infants?
- Are there reciprocal effects between parent and child outcomes as well as parental
emotional and functional coping outcomes?
- How do infant cognitive development and parental coping outcomes change over time
within the subjects and between the experimental groups?
- What factors moderate the effects of the intervention on child outcomes (e.g., family
structure, SES, birth-weight, disability, and infant temperament)?
- What is the incremental cost of the COPE intervention compared to the comparison group,
when the health care sector perspective is considered?
- What is the incremental cost of the COPE intervention compared to the comparison group
intervention, when the societal perspective is considered?
- How sensitive are the findings in these economic evaluations to the assumptions and
parameter estimates made in the analyses?
The first 3 years of life and the quality of early parent-child relations are principal
building blocks for adult cognitive and emotional functioning. However, investigators have
found that parents have impaired relationships with their premature infants, providing
heightened stimulation to the infants at inappropriate times in hopes of increasing
responsiveness to them. These dysfunctional patterns place parents at risk for negative
emotions and parenting outcomes and place children at risk for emotional, behavioral, and
developmental problems. Therefore, early interventions are critical to decrease the negative
effects of prematurity on parenting and parent-infant interactions. Early intervention may
be a critical key to future successful programs with parents and their premature infants
because it is recognized that, once a trajectory of parent-infant interaction is initiated,
changes are difficult to implement and even harder to sustain; this program has the
potential to benefit a significant number of LBW premature infants and their parents across
the country.
A randomized block design with repeated measures is being used. Subjects at each of two
study sites are randomly assigned to the COPE or comparison group by 4-week periods of time.
Using random assignment at each site will allow for assessment of an interaction effect as
part of the data analytic strategy. Based on the average NICU stay in the pilot study (mean
= 29.6 days), the decision to use 4-week blocks of time was made to decrease the likelihood
of parent to parent and staff to parent contamination which would be more likely with
individual randomization.
The COPE program provides parents with: (a) information on the appearance and behavioral
characteristics of premature infants and information on how parents can participate in their
infant's care, meet their infant's needs, enhance the quality of interaction with their
infant, and facilitate their infant's development (parental role information); and (b)
activities that assist parents in implementing the experimental information. The content of
the COPE program is driven by the theoretical framework, developmental theory, the
literature review, interventions found to be effective in previous studies, and prior work
by the research team.
The COPE program consists of 7 phases. Phase I (within 2 to 4 days after the infant's NICU
admission) consists of audiotaped information. A written copy of the information is also
provided for parents to read as they listen to the audiotape. Also, parents are given their
first set of parenting activities that consist of: (a) identifying the special
characteristics of their baby; and (b) keeping a record of milestones that their baby
achieves while in the NICU. Phase II (within 2 to 4 days after the first intervention)
consists of audiotaped and written information that reinforce the critical content of the
initial audiotape and provides supplemental information on: (a) premature infants' behaviors
and development; and (b) further suggestions regarding how parents can participate in their
infant's care and enhance their infant's development. Additional activities are introduced
to parents that consist of: (a) identifying the special characteristics of their baby at
this time; and (b) recognizing their baby's stress cues as well as cues that signal
readiness for communication. The parent activities are designed to: (a) supplement mothers
and fathers' existing parenting repertoire by providing them with parent activities specific
to the situation; (b) increase parents' confidence and certainty regarding how they can best
meet their infant's needs; and (c) enhance infant developmental outcomes. Phase III (1 to 4
days prior to the infant's discharge to home) consists of developmentally appropriate
information, including specific details about infant states and the best times for mothers
and fathers to interact with their infant. The audiotape also contains parental role
information regarding how to smooth the transition from hospital to home as well as how to
continue to foster a positive mother/father-baby relationship. Parent activities during
Phase III include: (a) continuing to assist parents in recognizing their baby's cues; and
(b) helping parents to recognize strategies that help their baby when he or she is stressed.
The Phase III intervention was planned for this window of time because discharge to home is
empirically supported as a stressful transition for parents.
Phase IV (within 1 week after discharge) is delivered in the parents' home. Audiotaped
information at this time contains information specific to continued growth and development
of the infant and suggestions for fostering a positive parent-infant relationship. Further
parenting activities are given to mothers and fathers that outline specific things for them
to do with their infant to foster his or her cognitive development (e.g. age appropriate
games and songs). One of these activities is a book, The Little Engine that Could, for
parents to read to their infants. Emphasis is placed upon interacting when the infant is
most receptive to stimuli (e.g., while in the quiet alert state). Phase V (2 months
corrected age) is also delivered in the parents' home. Parents again receive audiotaped and
written information about appropriate upcoming developmental milestones and how they can
enhance their infant's development. Emphasis is placed on specific age-appropriate
information about: (a) their infant's developmental characteristics; (b) typical sleep,
crying, and temperament patterns; and (c) strategies to foster their infant's cognitive and
social development. The COPE information places emphasis on assessing their infants based on
their corrected versus chronological age. Parenting activities in this phase of the
intervention include: (a) rattle play; (b) playing "peek-a-boo"; (c) repeating an action;
(d) tasting and touching to explore; and (e) vocalizing to take a turn. At Phase VI (9
months corrected age) parents are provided with audiotaped information that: (a) educates
them regarding what to expect in their infant's upcoming development; and (b) provides
suggestions for enhancing their child's development. Because mothers of LBW premature
infants frequently continue to view their children as "fragile" through the preschool years
and engage in overprotective parenting, this intervention focuses on the importance of
letting toddlers engage in autonomy, exploration, self-initiation, and self-assertion. The
COPE information outlines parenting strategies that foster positive attributes in the
children in addition to teaching age-appropriate limits. Parenting activities to enhance
development in this phase include: (a) learning the meaning of "no"; (b) learning about
colors and sizes; (c) finger-painting; (d) reading; and (e) identifying body parts. Phase
VII (18 months corrected age) information continues to emphasize the importance of allowing
the child to develop autonomy, self-initiation, and appropriate exploration. Detailed
information about the adverse effects of overprotective parenting is provided. Parents are
given more information about how to engage in appropriate limit setting and discipline as
well as strategies to continue to foster cognitive and social development with their
toddler. The following parent-child activities are provided: (a) playdough and paint-recipes
for fun; (b) matching objects to pictures; (c) learning to sort; (d) remembering where
things belong; (e) learning to imitate two word phrases; and (f) recognizing and naming
pictures.
The comparison program also consists of a series of audiotapes delivered at the same times
as the 7 phases of the COPE program. Phases I and II audiotaped and written information
contains information about the hospital services. The Phase III audiotape contains discharge
information that is given to all parents. The audiotape provided during the Phase IV
intervention contains information regarding immunizations. Phases V to VII audiotaped and
written interventions focus on age appropriate child safety and nutrition issues.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind
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