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Clinical Trials/NCT00939380
NCT00939380
Completed
Not Applicable

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

Rutgers, The State University of New Jersey5 sites in 1 country212 target enrollmentMay 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Childhood Cancers
Sponsor
Rutgers, The State University of New Jersey
Enrollment
212
Locations
5
Primary Endpoint
Beck Depression Inventory
Status
Completed
Last Updated
10 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
May 2010
End Date
May 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Beck Depression Inventory

Time Frame: 7 years

Beck Anxiety Inventory

Time Frame: 7 years

Mental Health Inventory

Time Frame: 7 years

Impact of Events Scale-Revised

Time Frame: 7 years

Axis I Structured Clinical Interview for DSM-IV (SCID)

Time Frame: 7 years

Secondary Outcomes

  • Fear Structure(7 years)
  • Brief COPE(7 years)

Study Sites (5)

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