Guided Participation Discharge Program for Very Preterm Infants

Not Applicable

Completed

• Conditions: Very Premature Baby
• Interventions: Behavioral: Guided participation discharge programme

• Registration Number: NCT03668912
• Lead Sponsor: Chinese University of Hong Kong

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-01
• Primary Completion: 2016-11-30
• Study Completion: 2016-12-31
• Status Verified: 2018-09
• Study First Submitted: 2018-09-11
• Study First Submitted QC: 2018-09-11
• Last Update Submitted: 2018-09-12
• Study First Posted: 2018-09-13
• Last Update Posted: 2018-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Guided participation group	Guided participation discharge programme	-

Primary Outcome Measures

Name	Time	Method
Parents' change in score of Parenting Sense of Competence Scale from baseline to up to 8 weeks	Baseline, and at 3-, 4-, and 8-weeks after baseline	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.

Secondary Outcome Measures

Name	Time	Method
Parents' change in score of Perceived Stress Scale from baseline to up to 8 weeks	Baseline, and at 3-, 4-, and 8-weeks after baseline	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.