Guided Participation Discharge Program for Very Preterm Infants

Study Overview
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Brief Summary
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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.

Official Title
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Feasibility of a Guided Participation Discharge Program for Very Preterm Infants

Conditions
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Very Premature Baby

Intervention / Treatment
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* Behavioral: Guided participation discharge programme


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 32 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Guided participation group<br> | Behavioral: Guided participation discharge programme<br>* A nurse-led GP discharge intervention (3 structured 30- to 60-minute GP sessions and 1 follow-up phone call)<br>|
| No Intervention: Usual care group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |