A Mobile Web-Based Parenting Intervention to Strengthen Social-Emotional Development of Low Birth Weight Infants

NCT05532202 | Completed

• 1 other identifier: R40MC26822
• Study Type: interventional
• Target: 102
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Intensive Care Units Neonatal; Parenting; Infant Health

Keywords

Telehealth; Parenting; Infant; Low Birthweight

Outcome Measures

Primary Outcomes (2)

• Indicator of Parent Child Interaction II- Mother behavior

  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

  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

Study Arms (2)

NICU Mom and Baby Net

EXPERIMENTAL

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.

Behavioral: NICU Mom and Baby Net

NICU Developmental Awareness System

ACTIVE COMPARATOR

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.

Other: NICU Developmental Awareness System

Interventions

NICU Mom and Baby Net BEHAVIORAL

See arm descriptions.

NICU Mom and Baby Net

NICU Developmental Awareness System OTHER

See arm description.

NICU Developmental Awareness System

Eligibility Criteria

• Age: 2 Months - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Georgia State University: lead
• Health Resources and Services Administration (HRSA): collaborator

Related Publications (2)

• 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.

  PMID: 32960178 BACKGROUND

• 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.

  PMID: 34160758 BACKGROUND

Study Officials

• Kathleen M Baggett, PhD

  Georgia State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants naive to treatment condition and Assessors naive to treatment condition and assessment time point
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Mark Chaffin Center for Healthy Development

Model Details: Randomized Controlled Pilot Trial Study

Study Record Dates

• First Submitted: July 23, 2022
• First Posted: September 8, 2022
• Study Start: February 11, 2015
• Primary Completion: June 16, 2017
• Study Completion: June 16, 2017
• Last Updated: September 21, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share