Clinical Trials Directory

Trials / Completed

CompletedNCT00939380

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
212 (actual)
Sponsor
Rutgers, The State University of New Jersey · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
BEHAVIORALBehavioral intervention sessionsParticipants 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.
OTHERCD-ROMParticipants receive a laptop computer and a CD-ROM after the first session of behavioral intervention.
OTHERDVD and pamphletParticipants 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.
OTHERRespite careParticipants receive 5 hours of respite care from a child-life specialist once or twice weekly for 3 weeks.

Timeline

Start date
2010-05-01
Primary completion
2015-01-01
Completion
2015-05-01
First posted
2009-07-15
Last updated
2016-03-10

Locations

5 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00939380. Inclusion in this directory is not an endorsement.