Guided Participation Discharge Program for Very Preterm Infants

Very Premature Baby Clinical Trial

Official title:

Feasibility of a Guided Participation Discharge Program for Very Preterm Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03668912
• Other study ID #: 001
• Status: Completed
• Phase: N/A
• Start date: March 1, 2016
• Est. completion date: December 31, 2016

Study information

• Verified date: September 2018
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aimed at investigating the feasibility of a new guided participation (GP) discharge program for parents of very preterm infants. A randomized controlled trial was conducted in a neonatal intensive care unit. The intervention included three structured GP sessions and one follow-up phone call. The control group received usual care. Outcomes measured included parents' efficacy and satisfaction with parenting, and perceived stress. Data collection was conducted at baseline, on day of discharge, after the follow-up phone call, and 1 month after discharge. The outcomes were analyzed on the basis of intention-to-treat principles.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 31, 2016
• Est. primary completion date: November 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 32 Weeks

Eligibility

For Infants:

Inclusion Criteria:

• A gestational age of =32 weeks at birth

Exclusion Criteria:

• Have congenital malformation(s)

• Need to undergo a major surgery

For Parents:

Inclusion Criteria:

• Must be the infant's primary caregiver

Inclusion Criteria:

• Diagnosed with a mental illness

Related Conditions & MeSH terms

• Very Premature Baby

Intervention

Behavioral:
• Guided participation discharge programme
A nurse-led GP discharge intervention (3 structured 30- to 60-minute GP sessions and 1 follow-up phone call)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parents' change in score of Parenting Sense of Competence Scale from baseline to up to 8 weeks	The Chinese version of the Parenting Sense of Competence Scale is a self-reported instrument which includes 17 items in two subscales (efficacy and satisfaction). Each item is rated on a 6- point Likert scale ('Strongly disagree' = 1; 'Strongly agree' = 6). Nine items (items 2, 3, 4, 5, 8, 9, 12, 14 and 16) were reverse-coded. The total scores ranged from 17 to 102. A higher score indicates a higher sense of competence and satisfaction with parenting by parents.	Baseline, and at 3-, 4-, and 8-weeks after baseline
Secondary	Parents' change in score of Perceived Stress Scale from baseline to up to 8 weeks	The Chinese version of the Perceived Stress Scale consists of 10 items. Each item is rated on a 5-point Likert scale ('never' = 0; 'very often' = 4). The total score is yielded by summing the scores of all items. The total score ranges from 0 to 40. The higher the score, the higher is the parents' perceived stress in parenting.	Baseline, and at 3-, 4-, and 8-weeks after baseline