Guided Participation Discharge Program for Very Preterm Infants
September 12, 2018 updated by: Lee Suk Yin, Chinese University of Hong Kong
Feasibility of a 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 7 months (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Usual care group
|
|
|
Experimental: Guided participation group
|
A nurse-led GP discharge intervention (3 structured 30- to 60-minute GP sessions and 1 follow-up phone call)
|
What is the study measuring?
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
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.
|
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
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.
|
Baseline, and at 3-, 4-, and 8-weeks after baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: lsy307@ha.org.hk Lee, Department of Pediatrics, Prince of Wales Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2016
Primary Completion (Actual)
November 30, 2016
Study Completion (Actual)
December 31, 2016
Study Registration Dates
First Submitted
September 11, 2018
First Submitted That Met QC Criteria
September 11, 2018
First Posted (Actual)
September 13, 2018
Study Record Updates
Last Update Posted (Actual)
September 14, 2018
Last Update Submitted That Met QC Criteria
September 12, 2018
Last Verified
September 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- 001 (Marta Eliza Miller Foundation)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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