Parent-child Interactions, Child Developmental Health, and Health System Costs at 6 Months Corrected Age

NCT03357458 | Completed

• 1 other identifier: ACHRI FICare 6mth
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this novel health services research proposal is to assess the longer-term outcomes, to 6 months corrected age, of an adapted Family Integrated Care (FICare) model of care for moderate and late preterm infants admitted to a Level II neonatal intensive care unit (NICU). This follow-up study will enroll infants at 6 months CA (± 1 month) recruited to the original FICare randomized controlled trial (clinicaltrials.gov ID: NCT02879799) from four level II NICU sites; two intervention and two control.

Conditions

Preterm Birth; Prematurity; Infant,Premature; Infant Development; Child Development; Parent-Child Relations; Mental Health Wellness 1

Keywords

Family Integrated Care; Parenting education; Nursing; Cost effectiveness; Patient engagement; Randomized controlled trial; Neonatal intensive care unit

Outcome Measures

Primary Outcomes (1)

• Maternal-Child Interactions

  We will measure maternal-child interactions using the Parent-child interaction Teaching Scale (PCITS) to code video-taped structured play sessions of mothers with their infants. The PCITS is the most widely used macro-level, binary observational measure of the presence or absence of dyadic behaviours. The parent total (50 items; possible score of 50) is the sum of subscales: Sensitivity to Cues, Response to Distress, Social-Emotional Growth Fostering, and Cognitive Growth Fostering. The child total (23 items; possible score of 23) is the sum of subscales: Responsiveness to Caregiver and Clarity of Cues. Higher scores indicate more optimal interactions. It has been validated with preterm infants.

  At 6-months corrected age

Secondary Outcomes (13)

• Infant global development

  At 6-months corrected age

• Infant social and emotional development

  At 6-months corrected age

• Maternal-reported infant sleep

  At 6-months corrected age

• Maternal parenting self-efficacy

  At 6-months corrected age

• Breastfeeding rates

  At 6-months corrected age

Study Arms (2)

Family Integrated Care

EXPERIMENTAL

Study participants receive FICare, a dynamic psycho-educational intervention, while their infant(s) was/were admitted to a Level II NICU.

Behavioral: Family Integrated Care

FICare Control Group

NO INTERVENTION

Study participants received standard care while their infant(s) was/were admitted to a Level II NICU.

Interventions

Family Integrated Care BEHAVIORAL

FICare is a dynamic psycho-educational intervention. The goal of FICare is a change in culture and practice that permits, encourages and supports parents in their parenting role while their infant is receiving health care in a Level II NICU. Underpinned by adult learning and change theories, FICare empowers parents to build their knowledge, skill and confidence so that the family is well-prepared to care for their infant long before discharge.

Family Integrated Care

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Mothers of infants born between 32 weeks and zero days and 34 weeks and 6 days gestation who enrolled in the FICare Alberta cluster controlled trial (cRCT) at one of four of the ten Level II NICU sites. The FICare cRCT enrolled mothers of any age who have decision making capacity; mothers who are able to speak, read and understand English well enough to provide informed consent, and complete surveys online or via telephone.

You may not qualify if:

• The FICare Alberta Level II NICU cRCT excluded mothers whose infants have serious congenital or chromosomal anomalies that require surgery, or are receiving palliative care; mothers who are not able to communicate in English; mothers with complex social issues.

Sponsors & Collaborators

• University of Calgary: lead
• Alberta Children's Hospital Research Institute: collaborator

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N1N4, Canada

Location

MeSH Terms

Conditions

Premature Birth; Patient Participation

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2017
• First Posted: November 30, 2017
• Study Start: January 22, 2018
• Primary Completion: March 3, 2019
• Study Completion: March 31, 2019
• Last Updated: April 17, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)