Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-28 @ 12:02 AM
Study NCT ID:
NCT05269693
Status:
COMPLETED
Last Update Posted:
2024-04-29
First Post:
2022-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A BHI to Increase Hope Level and Stress Level of Parents With a CMC
Sponsor:
The Hong Kong Polytechnic University
Organization:
Study Overview
Official Title:
A Brief Hope Intervention to Increase Hope Level and Decrease Stress Level of Parents With Children With Medical Complexity in the Community? A Pilot RCT
Status:
COMPLETED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Being a parent of a child with medical complexity (CMC) poses an enormous stress because these CMC have a multisystem disease, a severe neurologic condition or cancer which may result in premature death. Parents may feel challenged, lacking in confidence and high level of stress when managing their daily caregiving activities and child's new symptom. Literature suggested that hope is believed to be the central agent in facilitating positive psychological change when parents are facing difficulties and feeling stress. Brief Hope Intervention (BHI) is an alternative method considered to be feasible in improving parental hope level meanwhile, decreasing their stress level associated with daily caregiving activities. The purpose of BHI is to help these parents to develop workable goals, and concentrate on problem solving skill along with achievable planned actions in order to terminate the stressors associated from the caregiving activities.
This proposed pilot randomized controlled trial will test the feasibility and preliminary effect of the BHI in term of increasing the level of hope meanwhile decreasing the stress level of parents with a CMC. Eligibility, recruitment rates, and attrition rates will be collected in percentage to evaluate the feasibility of the study. Content analysis will be adopted to analysis the qualitative feedback on the acceptability of BHI from the parents. A repeated-measures, two-group design will be used to evaluate the preliminary effects between intervention and wait-listed control groups by comparing Brief Hope Intervention and wait-listed control groups receiving usual community care for 64 randomly selected parents over a 1-month follow-up. The outcome measures include parental hope and stress level. They will be measured before intervention, immediately after intervention and one-month after intervention.
With positive outcomes found in this study, this intervention will be implemented in a larger scale to improve local psychological health service for parents with a CMC.
This proposed pilot randomized controlled trial will test the feasibility and preliminary effect of the BHI in term of increasing the level of hope meanwhile decreasing the stress level of parents with a CMC. Eligibility, recruitment rates, and attrition rates will be collected in percentage to evaluate the feasibility of the study. Content analysis will be adopted to analysis the qualitative feedback on the acceptability of BHI from the parents. A repeated-measures, two-group design will be used to evaluate the preliminary effects between intervention and wait-listed control groups by comparing Brief Hope Intervention and wait-listed control groups receiving usual community care for 64 randomly selected parents over a 1-month follow-up. The outcome measures include parental hope and stress level. They will be measured before intervention, immediately after intervention and one-month after intervention.
With positive outcomes found in this study, this intervention will be implemented in a larger scale to improve local psychological health service for parents with a CMC.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: