A Mobile Web-Based Parenting Intervention to Strengthen Social-Emotional Development of Low Birth Weight Infants
Condition: Intensive Care Units Neonatal; Parenting; Infant Health
MeSH terms: Birth Weight
Study type: Interventional

Summary: 
      Low birth weight (LBW) infants are at significantly elevated risk for a host of detrimental
      outcomes including cognitive, language, and social delays and disabilities, which persist
      into adulthood. An important protective factor for mitigating risk is sensitive and
      responsive parenting. While evidence- based home visiting interventions exist and were
      developed specifically for LBW infants, such as the Play and Learning Strategies program,
      parents face major obstacles in accessing these interventions. In general, interventions
      demonstrated to be effective through federal research are very slow to migrate to community
      service delivery systems. Exacerbating this problem currently is the fact that while VLBW has
      been increasing, and disproportionately so for those who are poor an of minority status, home
      visiting programs have sustained some of the largest cuts in their histories. Consequently,
      there is high demand for effective interventions that can be delivered remotely. Through
      prior, the investigator team addressed this need by adapting the evidence-based PALS program
      for web-based delivery using laptop computers with streaming video of in-home parent child
      interactions and weekly remote coaching. The investigator team then rigorously tested its
      effects in a sample of low-income mothers and infants with typical birth histories. Results
      of this randomized controlled study showed pre-post growth in maternal sensitivity behaviors
      and significant increases in infants' social engagement with their mothers, with moderate to
      large effect sizes for the intervention group as compared to the control group. These
      encouraging results provide a strong empirical basis for the enhanced web-based delivery
      method of the PALS program. Although PALS was originally developed and tested with LBW
      infants, the web-based version, InfantNet, has not yet been tested with this population.
      Moreover, emergent trends show that young Latino and Black women most often access the
      Internet through smart phones, not laptops. Consequently, there is great demand for improving
      access to evidence-based interventions by making them available on mobile devices such as
      smart phones. Response: To address the need for more accessible evidence-based interventions,
      the investigator team will overlay the InfantNet program onto the iPhone and rigorously test
      its effects with 60 low- income mothers and their LBW infants through a 2-arm, 3 cohort,
      randomized-controlled design.
    

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.
    

Intervention name(s): NICU Mom and Baby Net; NICU Developmental Awareness System
Intervention type(s): Behavioral; Other
Intervention description(s): See arm descriptions.; See arm description.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Controlled Pilot Trial Study
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Telehealth; Parenting; Infant; Low Birthweight