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

Endocrine System Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05269693
• Other study ID #: HongKongPUSN
• Status: Completed
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: February 1, 2023

Study information

• Verified date: February 2022
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 1, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Palsy
• Endocrine System Diseases
• Muscular Atrophy
• Muscular Atrophy, Spinal

Intervention

Other:
• Brief Hope Intervention
The BHI consisted of 4 one-on-one sessions: 2 (1 hr) face- to-face sessions, and 2 (30 min) telephone follow-up sessions

Locations

Country	Name	City	State
China	School of Nursing, The Hong Kong Polytechnic University	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment	Enrollment and dropout rates will be calculated for each participant and summarized for all participants in the study	Week 4
Primary	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.	Week 4
Primary	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.	Week 0, Week 4, Week 8
Primary	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.	Week 0, Week 4, Week 8