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Completed

NCT Number: NCT05269693

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

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.

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Key information

Conditions

Child With Cancer Central Nervous System Diseases Child With Cerebral Palsy Endocrine System Diseases Motor Neuron Disease Muscular Atrophy, Spinal Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Spinal Cord Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Nursing, The Hong Kong Polytechnic University

Hong Kong, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Recruitment

    Time frame: Week 4

    Enrollment and dropout rates will be calculated for each participant and summarized for all participants in the study

  2. Intervention Delivery Rating Scale

    Time frame: 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.

  3. Change of Hope Level

    Time frame: 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.

  4. Change of Stress Level

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 8, 2022
Registry last updated
Apr 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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