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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02998086
Enrollment
107
Registered
2016-12-20
Start date
2016-12-05
Completion date
2020-12-31
Last updated
2021-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric Cancer

Brief 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.

Interventions

Skills-based intervention designed to promote resilience resources

Sponsors

Seattle Children's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Parents of children who: * Are aged 2-24 years * Have been diagnosed with new malignancy between 1-10 weeks prior * Are scheduled to receive cancer-directed therapy at Seattle Children's Hospital * Has provided written informed consent (child aged 18 years and older), written assent (child aged 13-17 years), verbal assent (child aged 7-12 years). * Able to speak and read English language * Cognitively able to participate in interactive interviews

Exclusion criteria

* Parent is \< 18 years of age * Parent is cognitively or physically unable to participate in interactive interview * Parent is unable to speak and read English language * Parent or child participated on prior PRISM intervention study

Design outcomes

Primary

MeasureTime frame
Parent-Reported Resilience3 months

Secondary

MeasureTime frame
Parent-reported Stress Survey Response3 months
Parent-reported psychological distress Survey Response3 months
Parent-reported social support Survey Response3 months
Parent-reported quality of life Survey Response3 months
Parent-reported benefit finding Survey Response3 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026