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

Summary

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.

Conditions

• Childhood Cancers

Interventions

BEHAVIORAL

Behavioral intervention sessions

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.

OTHER

CD-ROM

Participants receive a laptop computer and a CD-ROM after the first session of behavioral intervention.

OTHER

DVD and pamphlet

Participants 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.

OTHER

Respite care

Participants receive 5 hours of respite care from a child-life specialist once or twice weekly for 3 weeks.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Children's Hospital Los Angeles

  collaborator OTHER

• Columbia University

  collaborator OTHER

• Emory University

  collaborator OTHER

• Memorial Sloan Kettering Cancer Center

  collaborator OTHER

• University of Medicine and Dentistry of New Jersey

  collaborator OTHER

• Icahn School of Medicine at Mount Sinai

  collaborator OTHER

• Weill Medical College of Cornell University

  collaborator OTHER

• National Marrow Donor Program

  collaborator OTHER

• Rutgers, The State University of New Jersey

  lead OTHER

Principal Investigators

• Sharon L Manne, Ph.D. · Rutgers Cancer Institute of New Jersey

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2010-05-31

Primary Completion

2015-01-31

Completion

2015-05-31

Countries

• United States

Study Locations