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Completed

NCT Number: NCT03668912

Guided Participation Discharge Program for Very Preterm Infants

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.

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Key information

Conditions

Very Premature Baby

Age range

Up to 32 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Primary outcomes

  1. Parents' change in score of Parenting Sense of Competence Scale from baseline to up to 8 weeks

    Time frame: 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 outcomes

  1. Parents' change in score of Perceived Stress Scale from baseline to up to 8 weeks

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

Feasibility of a Guided Participation Discharge Program for Very Preterm Infants

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Sep 13, 2018
Registry last updated
Sep 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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