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

NCT ID: NCT05269693

Last Updated: 2024-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2023-02-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Brief Hope Intervention

Intervention Type: 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

wait-listed control group

Usual community care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: OTHER

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

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hong Kong Polytechnic University

OTHER

Sponsor Role: lead

Responsible Party

Dr Winsome Lam

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

School of Nursing, The Hong Kong Polytechnic University

Hong Kong, , China

Countries

China

Other Identifiers

HongKongPUSN

Identifier Type: -

Identifier Source: org_study_id