An interventional study of Brief Hope Intervention in Child With Cancer, Muscular Atrophy, Spinal and Child With Cerebral Palsy, sponsored by The Hong Kong Polytechnic University. Completed at 1 site in China. Per ClinicalTrials.gov, last updated 2024-04-29.
Sponsored by The Hong Kong Polytechnic University · Not applicable, Interventional, and Treatment
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.
294 studies on the registry are indexed under Muscular Atrophy, Spinal; 77 are open to participants now.
This study's enrollment of 40 is above the median of 27 across 165 interventional studies indexed under Muscular Atrophy, Spinal.
Browse Muscular Atrophy, Spinal studies →The Hong Kong Polytechnic University is the lead sponsor of 676 studies on the registry; 254 are open to participants now.
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Parents of a CMC will be recruited via the special schools for the children with physical disabilities. The eligible criteria for parents are
Exclusion Criteria:
Parents are
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
Usual community care
The BHI consisted of 4 one-on-one sessions: 2 (1 hr) face- to-face sessions, and 2 (30 min) telephone follow-up sessions
Recruitment
Enrollment and dropout rates will be calculated for each participant and summarized for all participants in the study
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Week 0, Week 4, Week 8
Plan to share: No
No publications or documents are linked to this record.
Ran from Dec 2021 to primary completion in Feb 2023, 14 months.
Of 51 non-industry interventional studies with no phase under Muscular Atrophy, Spinal, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 51. This study's 14 months is below that.
Counting every sponsor, half of 60 studies reached it within 26 months; a quarter within 17 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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The Hong Kong Polytechnic University →