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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Children's Hospital Los Angeles
Columbia University
Emory University
Memorial Sloan-Kettering Cancer Center
University of Medicine and Dentistry of New Jersey
Mount Sinai School of Medicine
Weill Medical College of Cornell University
National Marrow Donor Program
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT00939380
First received: July 14, 2009
Last updated: April 30, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Childhood Cancers
Behavioral: Behavioral intervention sessions
Other: CD-ROM
Other: DVD and pamphlet
Other: Respite care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Facilitating Parent Adaptation to Pediatric Transplant: The P-SCIP Trial

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • Beck Depression Inventory [ Time Frame: 7 years ] [ Designated as safety issue: No ]
  • Beck Anxiety Inventory [ Time Frame: 7 years ] [ Designated as safety issue: No ]
  • Mental Health Inventory [ Time Frame: 7 years ] [ Designated as safety issue: No ]
  • Impact of Events Scale-Revised [ Time Frame: 7 years ] [ Designated as safety issue: No ]
  • Axis I Structured Clinical Interview for DSM-IV (SCID) [ Time Frame: 7 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fear Structure [ Time Frame: 7 years ] [ Designated as safety issue: No ]
  • Brief COPE [ Time Frame: 7 years ] [ Designated as safety issue: No ]

Enrollment: 212
Study Start Date: August 2008
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: P-SCIP
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.
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.
Experimental: BPC
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.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00939380

Locations
United States, California
Childrens Hospital Los Angeles
Los Angeles, California, United States, 90027
United States, Georgia
Emory University/Childrens Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
United States, New Jersey
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 080903
United States, New York
Columbia University
New York, New York, United States, 10032
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Rutgers, The State University of New Jersey
Children's Hospital Los Angeles
Columbia University
Emory University
Memorial Sloan-Kettering Cancer Center
University of Medicine and Dentistry of New Jersey
Mount Sinai School of Medicine
Weill Medical College of Cornell University
National Marrow Donor Program
Investigators
Principal Investigator: Sharon L Manne, Ph.D. Rutgers Cancer Institute of New Jersey
  More Information

No publications provided

Responsible Party: Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT00939380     History of Changes
Obsolete Identifiers: NCT00953082
Other Study ID Numbers: 130906, 1 R01 CA127488-01A1, CDR0000632012, FCCC-07848, 0220090280, P30CA072720, IRB#07-848; 15032-01
Study First Received: July 14, 2009
Last Updated: April 30, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Rutgers, The State University of New Jersey:
hematopoietic stem cell transplant
bone marrow transplant
children
parents
counseling
depression

ClinicalTrials.gov processed this record on November 20, 2014