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

Sponsor

The Hong Kong Polytechnic University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05269693

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

4.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Child With Cancer Muscular Atrophy, Spinal Child With Cerebral Palsy Endocrine System Diseases	Other: Brief Hope Intervention	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

64 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Dec 1, 2021

Anticipated Primary Completion Date :

Nov 30, 2022

Anticipated Study Completion Date :

Jan 31, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Recruitment [Week 4]
Enrollment and dropout rates will be calculated for each participant and summarized for all participants in the study
Intervention Delivery Rating Scale [Week 4]
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 [Week 0, Week 4, Week 8]
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 [Week 0, Week 4, Week 8]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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

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.