- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05532202
A Mobile Web-Based Parenting Intervention to Strengthen Social-Emotional Development of Low Birth Weight Infants
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Infants born at low birth weight (LBW) present special health care needs and unique challenges to parenting, especially with regard to parents' ability to recognize and sensitively respond to subtle infant social communication signals15. Research has demonstrated the positive impact of parent sensitivity and responsiveness on infant cognitive, social-emotional, and language development as well as subsequent risk mitigation. In contrast, research has demonstrated the negative impact of adverse infant-parent interactions on infant social-emotional difficulties and subsequent internalizing and externalizing disorders. Sadly, poverty and associated environmental risks increase the probability of mothers experiencing both the birth of a LBW infant as well as subsequent parenting difficulties. While targeted interventions can strengthen maternal responsiveness and sensitivity, and, thereby, improve infant social-emotional behavior and developmental outcomes such interventions by and large have yet to reach children and families through home visitation service delivery systems. Moreover, national studies on access to Part-C early intervention programs show that families who are poor and of minority status tend to receive these services later, if at all, and when they do they are more likely to live in communities where service delivery systems are highly stressed and least resourced to deliver effective targeted intervention. Further compounding these service delivery issues is the growing incidence of LBW in the face of historically unprecedented funding cuts to home visitation programs. These issues underscore the need for research examining efficient delivery mechanisms for evidence-based interventions to promote healthy development and early positive behavior for all children, but especially for those with or at risk for disability due to LBW and poverty.
Consistent with the goals of Healthy People 2020 to: (a) achieve health equity, eliminate disparities, and improve the health of all groups; (b) create social and physical environments that promote good health; and (c) promote healthy development and healthy behaviors across every stage of life, we will address Maternal Child Health (MCH) Strategic Research Issue #IV: Promoting the healthy development of Maternal Child Health populations, and its correlate the Maternal Child Health Bureau Strategic Plan Fiscal Years 2003-2007, Goal 2: Promoting an Environment that Supports Maternal and Child Health. We will do so by focusing on efficient delivery of effective prevention strategies aimed at improving health and developmental outcomes for LBW infants. This project builds upon the investigator team's prior National Institute of Mental Health funded research efforts with mothers living in poverty wherein we adapted into a web-based format (InfantNet) the evidence-based Playing and Learning Strategies program (PALS). InfantNet demonstrated success not only in engaging mothers living in disadvantage into the intervention but also significantly strengthening maternal functioning as well as infant behavior in interaction at home13. It is within the context of this prior work and the framework of Healthy People 2020 goals and MCHB investments that the investigator team proposes the following aims and hypotheses: Aim 1: Implement and evaluate the effectiveness of InfantNet for mothers of LBW infants living in societal disadvantage. This aim includes the following: a) Increase the resonance and motivational impact of InfantNet specifically for mothers with LBW infants by adding initial session content related to the special needs of both LBW infants and mothers once exiting the Neonatal Intensive Care Unit (NICU) to go home; and increase the accessibility to LBW-InfantNet for these mothers and infants by overlaying the existing web-based InfantNet program onto mobile web-based access through Smart-Phone delivery, an increasingly prevalent technology in the lives of mothers. The new format will be called NICU Mom and Baby Net; b) Implement a randomized trial to evaluate the impact of NICU Mom and Baby Net with 60 mother-infant dyads living in disadvantage and exiting NICU in the Kansas City inner urban area. Mothers will be randomly assigned to receive either the NICU Mom and Baby Net intervention or a Smart-Phone Attention Control intervention containing information on general infant development. Mothers in both conditions will be provided with an iPhone for mobile web access to their assigned program. Mothers in each condition will be allowed a 6-month intervention period; c) Assess the effectiveness of NICU Mom and Baby Net relative to maternal and infant outcomes. Maternal outcome domains of interest are: observed maternal behavior in interaction with her infant as well as maternal parenting knowledge, attitudes and stress; infant outcome domains of interest are: observed infant behavior in interaction with their mother as well as general infant social-emotional functioning. Outcomes will be assessed at pre- and post-intervention (6-month interval); maintenance on selected outcomes will be assessed again at a 2-month, post intervention follow-up (see Method Variable Table for specific Aim indicators); d) Examine the extent to which maternal satisfaction with and use of the NICU Mom and Baby Net program are associated with positive parent-infant intervention outcomes. Usage indicators will be measured in a formative manner through electronic tracking of usage factors; satisfaction will be measured through within session streaming data report as well as through post-intervention questionnaires (see Variable Table below for specific Aim indicators). Aim 2: Evaluate the extent to which contextual and maternal intrapersonal risks relate to a) initial levels of observed parent and infant behavioral difficulties; and b) parent and infant behavioral change resulting from intervention (see Variables Table). Aim 3: Estimate the preliminary costs associated with InfantNet-VLBW implementation such that the benefits to mothers and their LBW infants can be viewed in relation to these costs by community agencies and policy makers. Hypotheses: 1) Mothers receiving NICU Mom and Baby Net will evidence greater gains in (a) observed maternal sensitive and responsive parenting behavior in interaction with their infant; (b) maternal knowledge of these behaviors; (c) general infant development knowledge; and (d) attitudes towards parenting when compared to their Attention Control Counterparts. Moreover, NICU Mom and Baby Net mothers will evidence greater reductions in: (a) parenting stress when compared to Attention Control mothers. 2) Infants of mothers receiving NICU Mom and Baby Net will evidence greater gains in: (a) observed infant social-emotional behaviors in interaction with their mothers; and (b) general social-emotional functioning when compared to Attention Control infants. 3) Higher levels of initial maternal contextual and intrapersonal risk will not only relate to higher initial levels of observed mother and infant behavioral difficulties, but also act to moderate NICU Mom and Baby Net effects such that those with higher risk levels will evidence lower intervention gain trajectories when compared to lower-risk mothers.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Biological or adoptive mothers living in the metropolitan area of Kansas City Missouri
- English speaking
- Infants at birth weighed <2500
- Infants at birth were at least 24 weeks' gestational age,
- Infants were no more than 5 months corrected gestational age at NICU exit
Exclusion Criteria:
- Infant diagnosis of hydrocephalus
- Infant diagnosis bronchopulmonary dysplasia
- Infant diagnosis beyond grade 3 intraventricular hemorrhage
- At the time of screening mother stated she was unable to meaningfully participate due to homelessness, inpatient drug or mental health treatment, physical illness requiring intensive treatment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: NICU Mom and Baby Net
12-session mobile internet intervention with remote video based coaching targeting maternal mood, sensitive and responsive parenting interactional practices with their infants to facilitate infant social engagement with their mothers.
Each session included (1) a web-based self-directed learning program through video-based teaching with check-in questions and provision of immediate corrective feedback, (2) an action plan outlining daily activity practice (homework) based on session content, (3) parent-recorded video and secure upload of session skill practice during interaction with her infant, and (4) a video-based coach call to co-view the parent-recorded video of interaction with her infant.
|
See arm descriptions.
|
Active Comparator: NICU Developmental Awareness System
Identical to NICU Mom and Baby Net in terms of number of sessions and session structure to serve as an equivalent attention control.
12-session mobile internet intervention with remote coaching of mother awareness of infant developmental milestones.
Each session included (1) web-based self-directed learning program through video-based teaching with check-in questions and provision of immediate corrective feedback, (2) an action plan outlining daily activity practice (homework) based on session content, (3) parent-recorded video and secure upload of session skill practice during interaction with her infant, and (4) a video-based coach call to co-view the parent-recorded video of interaction with her infant.
|
See arm description.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Indicator of Parent Child Interaction II- Mother behavior
Time Frame: Assessed Pre-intervention and Post- 6-month intervention
|
Pre-post change in direct observation of mother facilitators and interrupters of infant engagement during 5-minute semi-structured free play interaction with infant at home
|
Assessed Pre-intervention and Post- 6-month intervention
|
Indicator of Parent Child Interaction II- Infant behavior
Time Frame: Assessed Pre-intervention and Post- 6-month intervention
|
Pre-post change in direct observation of infant engagement and distress behavior during 5-minute semi-structured free play interaction with mother at home
|
Assessed Pre-intervention and Post- 6-month intervention
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Kathleen M Baggett, PhD, Georgia State University
Publications and helpful links
General Publications
- Baggett KM, Davis B, Landry SH, Feil EG, Whaley A, Schnitz A, Leve C. Understanding the Steps Toward Mobile Early Intervention for Mothers and Their Infants Exiting the Neonatal Intensive Care Unit: Descriptive Examination. J Med Internet Res. 2020 Sep 22;22(9):e18519. doi: 10.2196/18519.
- Davis B, Baggett KM, Patterson AL, Feil EG, Landry SH, Leve C. Power and Efficacy of Maternal Voice in Neonatal Intensive Care Units: Implicit Bias and Family-Centered Care. Matern Child Health J. 2022 Apr;26(4):905-912. doi: 10.1007/s10995-021-03199-z. Epub 2021 Jun 23.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R40MC26822
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Parenting
-
Johns Hopkins UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development...Not yet recruiting
-
Johns Hopkins UniversityThe Rita and Alex Hillman Foundation; Abell Foundation; Richman Foundation; Sherman... and other collaboratorsRecruitingParenting | Parenting InterventionUnited States
-
Tampere University HospitalTampere UniversityCompletedParenting Satisfaction | Parenting Self-efficacyFinland
-
University of MinnesotaArizona State UniversityCompleted
-
WestatMakerere UniversityCompleted
-
Central Hospital, Nancy, FranceCompleted
-
Yale UniversityCompleted
-
Georgetown UniversityRecruiting
-
University of South FloridaEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedParentingUnited States
Clinical Trials on NICU Mom and Baby Net
-
Georgia State UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedMaternal Depression and Parent Practices, Postpartum | Infant Social-Emotional and Social Communication Competency DevelopmentUnited States
-
Rush University Medical CenterNational Institute on Minority Health and Health Disparities (NIMHD); Ohio...RecruitingPreterm Birth | Infant, Very Low Birth Weight | Milk, Human | Pumping, BreastUnited States
-
Oregon Research InstituteRecruiting
-
Oregon Research InstituteCompleted
-
Oregon Research InstituteCompletedMaternal Care PatternsUnited States
-
Children's Hospital Medical Center, CincinnatiUniversity of CincinnatiCompletedSudden Unexplained Infant Death | Child Rearing | LiteracyUnited States
-
University of NottinghamHeartlight Systems LimitedSuspended
-
Stony Brook UniversityUniversity of MichiganRecruitingOpioid Use DisorderUnited States
-
Brigham and Women's HospitalPOM Wonderful LLCRecruiting
-
Federico II UniversityCompletedST-elevation Myocardial Infarction | Thrombus | StentsItaly