Clinical trial NCT05269693: A BHI to Increase Hope Level and Stress Level of Parents With a CMC
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child With Cancer
Muscular Atrophy, Spinal
Child With Cerebral Palsy
Endocrine System Diseases
Keywords: Brief Hope Therapy
Parent
Children with medical complexity
stress
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2022-03-08
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a single-blinded, pilot randomized controlled trial with two-armed repeated measures
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Recruitment
timeFrame: Week 4
measure: Intervention Delivery Rating Scale
timeFrame: Week 4
measure: Change of Hope Level
timeFrame: Week 0, Week 4, Week 8
measure: Change of Stress Level
timeFrame: Week 0, Week 4, Week 8
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: School of Nursing, The Hong Kong Polytechnic University
Study officials:
References: