PRISM for Parents of Children With Cancer Promoting Resilience in Stress Management (PRISM) Intervention for Parents of Children With Cancer

March 15, 2021 updated by: Abby Rosenberg, Seattle Children's Hospital

A Pilot Randomized Controlled Trial of the Promoting Resilience in Stress Management (PRISM) Intervention for Parents of Children With Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

107

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98145
        • Seattle Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Individual (1:1)
Individual, 1:1 version of the Promoting Resilience in Stress Management for Parents (PRISM-P) intervention
Behavioral: Promoting Resilience in Stress Management
Skills-based intervention designed to promote resilience resources
Other Names:
  • PRISM
Experimental: Group
Group-based version of the Promoting Resilience in Stress Management for Parents (PRISM-P) intervention
Behavioral: Promoting Resilience in Stress Management
Skills-based intervention designed to promote resilience resources
Other Names:
  • PRISM
No Intervention: Usual Care
Usual non-directed psychosocial supportive care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Parent-Reported Resilience
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Parent-reported Stress Survey Response
Time Frame: 3 months
3 months
Parent-reported psychological distress Survey Response
Time Frame: 3 months
3 months
Parent-reported social support Survey Response
Time Frame: 3 months
3 months
Parent-reported quality of life Survey Response
Time Frame: 3 months
3 months
Parent-reported benefit finding Survey Response
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seattle Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 5, 2016

Primary Completion (Actual)

December 30, 2018

Study Completion (Actual)

December 1, 2020

Study Registration Dates

First Submitted

December 13, 2016

First Submitted That Met QC Criteria

December 15, 2016

First Posted (Estimate)

December 20, 2016

Study Record Updates

Last Update Posted (Actual)

March 17, 2021

Last Update Submitted That Met QC Criteria

March 15, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • SC-N120

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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