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Randomized Controlled Trial
. 2019 Sep 4;2(9):e1911578.
doi: 10.1001/jamanetworkopen.2019.11578.

Effect of the Promoting Resilience in Stress Management Intervention for Parents of Children With Cancer (PRISM-P): A Randomized Clinical Trial

Affiliations
Randomized Controlled Trial

Effect of the Promoting Resilience in Stress Management Intervention for Parents of Children With Cancer (PRISM-P): A Randomized Clinical Trial

Abby R Rosenberg et al. JAMA Netw Open. .

Abstract

Importance: Parents of children with serious illness, such as cancer, experience high stress and distress. Few parent-specific psychosocial interventions have been evaluated in randomized trials.

Objective: To determine if individual- or group-based delivery of a novel intervention called Promoting Resilience in Stress Management for Parents (PRISM-P) improves parent-reported resilience compared with usual care.

Design, setting, and participants: This parallel, phase 2 randomized clinical trial with enrollment from December 2016 through December 2018 and 3-month follow-up was conducted at Seattle Children's Hospital. English-speaking parents or guardians of children who were 2 to 24 years old, who had received a diagnosis of a new malignant neoplasm 1 to 10 weeks prior to enrollment, and who were receiving cancer-directed therapy at Seattle Children's Hospital were included. Parents were randomized 1:1:1 to the one-on-one or group PRISM-P intervention or to usual care. Data were analyzed in 2019 (primary analyses from January to March 2019; final analyses in July 2019).

Interventions: The PRISM-P is a manualized, brief intervention targeting 4 skills: stress management, goal setting, cognitive reframing, and meaning making. For one-on-one delivery, skills were taught privately and in person for 30 to 60 minutes approximately every other week. For group delivery, the same skills were taught in a single session with at least 2 parents present.

Main outcomes and measures: Participants completed patient-reported outcome surveys at enrollment and at 3 months. Linear regression modeling evaluated associations in the intention-to-treat population between each delivery format and the primary outcome (Connor-Davidson Resilience Scale scores, ranging from 0 to 40, with higher scores reflecting greater resilience) and secondary outcomes (benefit finding, social support, health-related quality of life, stress, and distress) at 3 months.

Results: In total, 94 parents enrolled, were randomized to 1 of the 3 groups, and completed baseline surveys (32 parents in one-on-one sessions, 32 in group sessions, and 30 in usual care). Their median (interquartile range) ages were 35 to 38 (31-44) years across the 3 groups, and they were predominantly white, college-educated mothers. Their children had median (interquartile range) ages of 5 to 8 (3-14) years; slightly more than half of the children were boys, and the most common cancer type was leukemia or lymphoma. One-on-one PRISM-P delivery was significantly associated with improvement compared with usual care in parent-reported outcomes for resilience (β, 2.3; 95% CI, 0.1-4.6; P = .04) and for benefit finding (β, 0.5; 95% CI, 0.2-0.8; P = .001). No significant associations were detected between either platform and other parent-reported outcomes.

Conclusions and relevance: When delivered individually, PRISM-P was associated with improved parent-reported resilience and benefit finding. This scalable psychosocial intervention may help parents cope and find meaning after their child receives a diagnosis of a serious illness.

Trial registration: ClinicalTrials.gov identifier: NCT02998086.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Rosenberg reported receiving a grant from the National Palliative Care Research Center during the conduct of the study. Dr Taylor reported receiving a grant from the University of Washington during the conduct of the study. Dr Kross reported receiving grants from the National Institutes of Health, the American Lung Association, and the American Thoracic Society outside the submitted work. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. CONSORT Flow Diagram of Study Enrollment and Retention
aParticipants were randomized into 1 of 3 groups: one-on-one (1:1) sessions, in which Promoting Resilience in Stress Management for Parents (PRISM-P) was delivered individually and privately to a single parent, with each of the 4 PRISM-P skills (to find out what these are, see the introductory paragraph of the text) taught approximately every other week; group sessions, in which PRISM-P was delivered to 2 or more parents at once, with all 4 skills learned in the same sitting; or usual care, in which no PRISM-P or other intervention was provided.
Figure 2.
Figure 2.. Mean Difference in Parent Outcome Score Change Associated With Promoting Resilience in Stress Management for Parents (PRISM-P) Intervention
One-on-one (1:1) indicates PRISM-P delivered individually to a single parent, with each of the 4 PRISM-P skills (to find out what these are, see the introductory paragraph of the text) taught approximately every other week. Group indicates PRISM-P delivered to 2 or more parents at once, with all 4 skills learned in the same sitting. UC represents usual care, with no PRISM-P or other intervention. Squares indicate effect estimates; horizontal lines, 95% CIs from adjusted linear regression models after multiple imputation for missing 3-month scores.

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