Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00120614
Status:
COMPLETED
Last Update Posted:
2009-04-08
First Post:
2005-07-07
Brief Title:
EducationalBehavioral Intervention Program for Parents of Premature Infants
Sponsor:
University of Rochester
Organization:
University of Rochester
Study Overview
Official Title:
Improving Outcomes of LBW Premature Infants and Parents
Status:
COMPLETED
Status Verified Date:
2009-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether beginning an enriched educationalbehavioral 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 infants 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 infanttoddler 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 mothers and fathers ability to parent their premature child in a way that will help support their childs brain development and learning ability and to also decrease negative behaviors as the child grows
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 infants 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 infanttoddler 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 mothers and fathers ability to parent their premature child in a way that will help support their childs brain development and learning ability and to also decrease negative behaviors as the child grows
Detailed Description:
The incidence of premature and low birthweight LBW births continues to climb in the US 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 fatherssignificant 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 fatherssignificant 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 eg 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 fatherssignificant others
Mothersfathers who receive the COPE program will report less anxiety depression and stress related to the NICU environment than mothersfathers who receive the comparison program
Mothersfathers who receive the COPE program will demonstrate a higher quality of parenting during hospitalization than mothersfathers who receive the comparison program
Mothersfathers who receive the COPE program will report less anxiety and depression following hospitalization than mothersfathers who receive the comparison program
Mothersfathers who receive the COPE program will perceive their children as less vulnerable than mothersfathers 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 mothersfathers who receive the COPE program will have greater cognitive development than infants of mothersfathers in the comparison program
Children of mothersfathers in the COPE program will have less negative behaviors at 2 years corrected age than children of mothersfathers 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 eg 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 296 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 infants care meet their infants needs enhance the quality of interaction with their infant and facilitate their infants 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 infants 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 infants care and enhance their infants 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 babys 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 infants needs and c enhance infant developmental outcomes Phase III 1 to 4 days prior to the infants 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 motherfather-baby relationship Parent activities during Phase III include a continuing to assist parents in recognizing their babys 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 eg 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 eg 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 infants development Emphasis is placed on specific age-appropriate information about a their infants developmental characteristics b typical sleep crying and temperament patterns and c strategies to foster their infants 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 infants upcoming development and b provides suggestions for enhancing their childs 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
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 fatherssignificant 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 fatherssignificant 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 eg 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 fatherssignificant others
Mothersfathers who receive the COPE program will report less anxiety depression and stress related to the NICU environment than mothersfathers who receive the comparison program
Mothersfathers who receive the COPE program will demonstrate a higher quality of parenting during hospitalization than mothersfathers who receive the comparison program
Mothersfathers who receive the COPE program will report less anxiety and depression following hospitalization than mothersfathers who receive the comparison program
Mothersfathers who receive the COPE program will perceive their children as less vulnerable than mothersfathers 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 mothersfathers who receive the COPE program will have greater cognitive development than infants of mothersfathers in the comparison program
Children of mothersfathers in the COPE program will have less negative behaviors at 2 years corrected age than children of mothersfathers 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 eg 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 296 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 infants care meet their infants needs enhance the quality of interaction with their infant and facilitate their infants 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 infants 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 infants care and enhance their infants 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 babys 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 infants needs and c enhance infant developmental outcomes Phase III 1 to 4 days prior to the infants 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 motherfather-baby relationship Parent activities during Phase III include a continuing to assist parents in recognizing their babys 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 eg 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 eg 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 infants development Emphasis is placed on specific age-appropriate information about a their infants developmental characteristics b typical sleep crying and temperament patterns and c strategies to foster their infants 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 infants upcoming development and b provides suggestions for enhancing their childs 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5RO1MR5077-5 | None | None | None |