Guided Participation Discharge Program for Very Preterm Infants

NCT03668912 | Completed DMC

• 1 other identifier: 001
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Very Premature Baby

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

Guided participation group

EXPERIMENTAL

Behavioral: Guided participation discharge programme

Usual care group

NO INTERVENTION

Interventions

Guided participation discharge programme BEHAVIORAL

A nurse-led GP discharge intervention (3 structured 30- to 60-minute GP sessions and 1 follow-up phone call)

Guided participation group

Eligibility Criteria

• Age: Up to 32 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \- A gestational age of ≤32 weeks at birth

You may not qualify if:

• Have congenital malformation(s)
• Need to undergo a major surgery
• For Parents:
• \- Must be the infant's primary caregiver
• \- Diagnosed with a mental illness

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Related Publications (1)

• Lee SY, Chau JPC, Choi KC, Lo SHS. Feasibility of a guided participation discharge program for very preterm infants in a neonatal intensive care unit: a randomized controlled trial. BMC Pediatr. 2019 Nov 4;19(1):402. doi: 10.1186/s12887-019-1794-y.

  PMID: 31684903 DERIVED

Study Officials

• lsy307@ha.org.hk Lee

  Department of Pediatrics, Prince of Wales Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 11, 2018
• First Posted: September 13, 2018
• Study Start: March 1, 2016
• Primary Completion: November 30, 2016
• Study Completion: December 31, 2016
• Last Updated: September 14, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share