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Guided Participation Discharge Program for Very Preterm Infants

Feasibility of a Guided Participation Discharge Program for Very Preterm Infants

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03668912
Enrollment
30
Registered
2018-09-13
Start date
2016-03-01
Completion date
2016-12-31
Last updated
2018-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Very Premature Baby

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.

Interventions

BEHAVIORALGuided participation discharge programme

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

Sponsors

Chinese University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
No minimum to 32 Weeks
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Parents' change in score of Parenting Sense of Competence Scale from baseline to up to 8 weeksBaseline, and at 3-, 4-, and 8-weeks after baselineThe 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

MeasureTime frameDescription
Parents' change in score of Perceived Stress Scale from baseline to up to 8 weeksBaseline, and at 3-, 4-, and 8-weeks after baselineThe 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026