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

NCT05269693 | Completed

• 1 other identifier: HongKongPUSN
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Child With Cancer; Muscular Atrophy, Spinal; Child With Cerebral Palsy; Endocrine System Diseases

Keywords

Brief Hope Therapy; Parent; Children with medical complexity; stress

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

the Brief Hope Intervention group

EXPERIMENTAL

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

wait-listed control group

NO INTERVENTION

Usual community care

Interventions

Brief Hope Intervention OTHER

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

the Brief Hope Intervention group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

School of Nursing, The Hong Kong Polytechnic University

Hong Kong, China

Location

MeSH Terms

Conditions

Muscular Atrophy, Spinal; Endocrine System Diseases

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; Neuromuscular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This is a single-blinded, pilot randomized controlled trial with two-armed repeated measures

Study Record Dates

• First Submitted: January 5, 2022
• First Posted: March 8, 2022
• Study Start: December 1, 2021
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: April 29, 2024

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)