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A BHI to Increase Hope Level and Stress Level of Parents With a CMC: a Feasibility Study

Primary Purpose

Child With Cancer, Muscular Atrophy, Spinal, Child With Cerebral Palsy

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Brief Hope Intervention
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Child With Cancer focused on measuring Brief Hope Therapy, Parent, Children with medical complexity, stress

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Parents of a CMC will be recruited via the special schools for the children with physical disabilities. The eligible criteria for parents are

  1. one of the parent of a child with medical complexity aged 5-18,
  2. able to communicate in Chinese and read Chinese,
  3. willing to participate in face-to-face activities and a telephone follow-up,
  4. alert and oriented, able to sustain approximately 1 hour of attention and interaction, and
  5. able to be reached by phone.

Exclusion Criteria:

Parents are

  1. a reported mental health disorder,
  2. inability to communicate in Cantonese,
  3. engaging in other Hope Therapy related to stress relief and hope enhancement, and
  4. severe hearing deficit that prevented them from engaging in phone communication.

Sites / Locations

  • School of Nursing, The Hong Kong Polytechnic UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

the Brief Hope Intervention group

wait-listed control group

Arm Description

The BHI consisted of 4 one-on-one sessions: 2 (1 hr) face- to-face sessions, and 2 (30 min) telephone follow-up sessions in-between.

Usual community care

Outcomes

Primary Outcome Measures

Recruitment
Enrollment and dropout rates will be calculated for each participant and summarized for all participants in the study
Intervention Delivery Rating Scale
5-point Likert scale for evaluating the useful level of intervention, ranging from 1 (not at all) to 5 (most).Higher scores mean more better outcome.
Change of Hope Level
State Hope Scale (Chinese version): consisting of 6 items. Each item is rated on a 8-point scale, with 1 = definitely false and 8 = definitely true. Higher scores mean higher hope level.
Change of Stress Level
Perceived Stress Scale (Chinese version): consisting of 14 items. Each item is rated on a 5-point scale, ranging from 1 (not at all) to 5 (extremely). Higher scores mean higher stress level.

Secondary Outcome Measures

Full Information

First Posted
January 5, 2022
Last Updated
February 25, 2022
Sponsor
The Hong Kong Polytechnic University
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1. Study Identification

Unique Protocol Identification Number
NCT05269693
Brief Title
A BHI to Increase Hope Level and Stress Level of Parents With a CMC: a Feasibility Study
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 Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
November 30, 2022 (Anticipated)
Study Completion Date
January 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Child With Cancer, Muscular Atrophy, Spinal, Child With Cerebral Palsy, Endocrine System Diseases
Keywords
Brief Hope Therapy, Parent, Children with medical complexity, stress

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a single-blinded, pilot randomized controlled trial with two-armed repeated measures
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
the Brief Hope Intervention group
Arm Type
Experimental
Arm Description
The BHI consisted of 4 one-on-one sessions: 2 (1 hr) face- to-face sessions, and 2 (30 min) telephone follow-up sessions in-between.
Arm Title
wait-listed control group
Arm Type
No Intervention
Arm Description
Usual community care
Intervention Type
Other
Intervention Name(s)
Brief Hope Intervention
Intervention Description
The BHI consisted of 4 one-on-one sessions: 2 (1 hr) face- to-face sessions, and 2 (30 min) telephone follow-up sessions
Primary Outcome Measure Information:
Title
Recruitment
Description
Enrollment and dropout rates will be calculated for each participant and summarized for all participants in the study
Time Frame
Week 4
Title
Intervention Delivery Rating Scale
Description
5-point Likert scale for evaluating the useful level of intervention, ranging from 1 (not at all) to 5 (most).Higher scores mean more better outcome.
Time Frame
Week 4
Title
Change of Hope Level
Description
State Hope Scale (Chinese version): consisting of 6 items. Each item is rated on a 8-point scale, with 1 = definitely false and 8 = definitely true. Higher scores mean higher hope level.
Time Frame
Week 0, Week 4, Week 8
Title
Change of Stress Level
Description
Perceived Stress Scale (Chinese version): consisting of 14 items. Each item is rated on a 5-point scale, ranging from 1 (not at all) to 5 (extremely). Higher scores mean higher stress level.
Time Frame
Week 0, Week 4, Week 8

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Parents of a CMC will be recruited via the special schools for the children with physical disabilities. The eligible criteria for parents are one of the parent of a child with medical complexity aged 5-18, able to communicate in Chinese and read Chinese, willing to participate in face-to-face activities and a telephone follow-up, alert and oriented, able to sustain approximately 1 hour of attention and interaction, and able to be reached by phone. Exclusion Criteria: Parents are a reported mental health disorder, inability to communicate in Cantonese, engaging in other Hope Therapy related to stress relief and hope enhancement, and severe hearing deficit that prevented them from engaging in phone communication.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Winsome Lam, PhD
Phone
2766
Ext
4291
Email
winsome.lam@polyu.edu.hk
First Name & Middle Initial & Last Name or Official Title & Degree
School of Nursing
Phone
2766
Ext
4369
Email
sn.go@polyu.edu.hk
Facility Information:
Facility Name
School of Nursing, The Hong Kong Polytechnic University
City
Hong Kong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Winsome Lam, PhD
Phone
2766
Ext
4291
Email
winsome.lam@polyu.edu.hk

12. IPD Sharing Statement

Plan to Share IPD
No

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A BHI to Increase Hope Level and Stress Level of Parents With a CMC: a Feasibility Study

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