Trials / Completed
CompletedNCT02998086
PRISM for Parents of Children With Cancer Promoting Resilience in Stress Management (PRISM) Intervention for Parents of Children With Cancer
A Pilot Randomized Controlled Trial of the Promoting Resilience in Stress Management (PRISM) Intervention for Parents of Children With Cancer
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 107 (actual)
- Sponsor
- Seattle Children's Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Parenting a child with cancer is highly stressful. The investigators have designed a promising parent-centered intervention to bolster parent resilience and reduce stress and distress. This study will test 2 formats of the intervention (individual or group-based) and compare them to usual care.
Detailed description
Parenting a child with cancer is highly distressing. Both during and after cancer therapy, parents may suffer from poor mental health, risky health behaviors, and financial hardship, all of which may impact patients, siblings, and the family unit. Positive psychological resources can mitigate negative outcomes. In this regard, resilience is particularly important, describing an individual's ability to maintain psychological and/or physical well-being in the face of stress. The investigators have previously described the "Promoting Resilience in Stress Management" (PRISM) intervention for adolescent and young adult patients with cancer. This brief, 1:1 intervention targets four "resilience resources" over approximately 3 months: skills in stress-management/mindfulness, goal-setting, cognitive restructuring, and meaning-making. Notably, every parent whose child received the PRISM requested a similar intervention for him- or herself. Hence, the investigators adapted two versions of the intervention for parents (the "PRISM-P"). First, using the same 1:1 format, they piloted the PRISM-P amongst 12 parents of children with cancer. Feedback was highly positive; however, many parents requested additional group-based social support. Second, they conducted a half-day symposium and administered small-group adaptations of the PRISM-P to 70 parents of children with serious illness. Feedback was again positive; however, the opportunity to develop individual skills was limited. This application proposes a pilot Randomized Clinical Trial (RCT) to evaluate and compare these 2 formats of the PRISM-P with usual care, in order to determine optimal methodologies and preferences for future, larger studies. Consecutive eligible parents of children with newly diagnosed cancer will be randomly assigned to one of the 3 options (N=75 total, n=25 per arm). Secondary aims will assess parent-reported stress, burden of care, hope, goals, optimism, benefit-finding, psychological distress, and health behaviors, and ongoing perceptions of usefulness, feasibility, and preference.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Promoting Resilience in Stress Management | Skills-based intervention designed to promote resilience resources |
Timeline
- Start date
- 2016-12-05
- Primary completion
- 2018-12-30
- Completion
- 2020-12-01
- First posted
- 2016-12-20
- Last updated
- 2021-03-17
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02998086. Inclusion in this directory is not an endorsement.