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

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

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.

Study Overview

• Status: Completed
• Conditions: Endocrine System Diseases; Muscular Atrophy, Spinal; Child With Cancer; Child With Cerebral Palsy
• Intervention / Treatment: Other: Brief Hope Intervention

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hong Kong, China
    • School of Nursing, The Hong Kong Polytechnic University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: the Brief Hope Intervention group; 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.	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
No Intervention: wait-listed control group; Usual community care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment	Enrollment and dropout rates will be calculated for each participant and summarized for all participants in the study	Week 4
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
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
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

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): February 1, 2023
• Study Completion (Actual): February 1, 2023

Study Registration Dates

• First Submitted: January 5, 2022
• First Submitted That Met QC Criteria: February 25, 2022
• First Posted (Actual): March 8, 2022

Study Record Updates

• Last Update Posted (Actual): April 29, 2024
• Last Update Submitted That Met QC Criteria: April 25, 2024
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: stress; Parent; Children with medical complexity; Brief Hope Therapy
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Neuromuscular Diseases; Neurodegenerative Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Spinal Cord Diseases; Atrophy; Motor Neuron Disease; Cerebral Palsy; Muscular Atrophy; Endocrine System Diseases; Muscular Atrophy, Spinal
• Other Study ID Numbers: HongKongPUSN

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