Facilitating Parent Adaptation to Pediatric Transplant: The P-SCIP Trial

Rutgers The State University of New Jersey

Status: Completed

Conditions: Childhood Cancers

Treatments: Other: Respite care; Behavioral: Behavioral intervention sessions; Other: CD-ROM; Other: DVD and pamphlet

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00939380

IRB#07-848 ( 15032-01;Other Identifier)

P30CA072720 (U.S. NIH Grant/Contract)

1R01CA127488-01A1 (U.S. NIH Grant/Contract)

130906

FCCC-07848

0220090280 (Other Identifier)

CDR0000632012 (Registry Identifier)

Details and patient eligibility

About

The investigators have developed a parent social-cognitive processing intervention (P-SCIP) to help decrease distress among parent caregivers of children undergoing hematopoietic stem cell transplant (HSCT). The investigators will evaluate the efficacy of P-SCIP in reducing short- and long-term distress and parenting stress among 300 parents of children undergoing HSCT. P-SCIP will be delivered during the child's inpatient HSCT hospitalization and is specifically designed to improve parent social (e.g., sharing concerns) and cognitive (e.g., acceptance) processing of the transplant experience. The intervention includes five in-person sessions that are accompanied by an interactive CD-ROM. The CD-ROM complements the materials in the in-person sessions and provides parents with the opportunity to enhance and deepen their cognitive and social processing of the HSCT experience. The intervention will be tested against best-practices psychosocial care (BPC) available in four enriched pediatric HSCT settings across the United States. P-SCIP will be provided to both Spanish- and English-speaking parents. Participants will complete measures of psychological distress, well-being, and social and cognitive processing at the time of HSCT, two, six and twelve months after HSCT. Research questions will address the effects of P-SCIP versus BPC on parent psychological adaptation and social and cognitive processing, as well as evaluate parent personal resources as well as child medical course variables that contribute to intervention response. The investigators will also examine barriers to participation in the intervention by comparing barriers to participation among parents who refuse participation in the trial and parents who accept.

Enrollment: 212 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• biological or foster parent of children under 19 years of age who are scheduled for HSCT within the next month
• participant is the primary caregiver
• participant must have phone service
• caregiver speaks, reads, and writes English or Spanish (Spanish is for Childrens Hospital Los Angeles and Columbia University only)

Exclusion criteria

• pediatric patient has a diagnosis of medulloblastoma or other cancer of the brain

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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212 participants in 2 patient groups

P-SCIP

Experimental group

Description:

Arm I (Parent Social-Cognitive Intervention Program \[P-SCIP\]): Participants undergo five 60-minute behavioral intervention sessions once or twice weekly for 3 weeks to learn how to engage in effective social and cognitive processing to deal with fears and worries about the transplant and transplant-related concerns. Participants receive a laptop computer and a CD-ROM after the first session.

Treatment:

Other: CD-ROM

Behavioral: Behavioral intervention sessions

BPC

Experimental group

Description:

Arm II (Best-recommended Psychosocial Care \[BPC\]): Participants undergo usual care and receive a "Discovery to Recovery" DVD and pamphlet developed by the National Marrow Donor Program (NMDP) describing psychological issues associated with hematopoietic stem cell transplantation (HSCT), the booklet "Top Tips for Parent Caregivers During the BMT Process" published by National Marrow Donor Program-Link describing caregiver issues during HSCT and advice on how to handle them, 2 walkie-talkies, a laptop to view the DVD, and 5 hours of respite care from a child-life specialist once or twice weekly for 3 weeks.

Treatment:

Other: Respite care

Other: DVD and pamphlet