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

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.

Study Overview

• Status: Completed
• Conditions: Childhood Cancers
• Intervention / Treatment: Behavioral: Behavioral intervention sessions; Other: CD-ROM; Other: DVD and pamphlet; Other: Respite care

• Study Type: Interventional
• Enrollment (Actual): 212
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90027
      • Childrens Hospital Los Angeles
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University/Childrens Healthcare of Atlanta
  • New Jersey
    • New Brunswick, New Jersey, United States, 080903
      • Rutgers Cancer Institute of New Jersey
  • New York
    • New York, New York, United States, 10021
      • Memorial Sloan-Kettering Cancer Center
    • New York, New York, United States, 10032
      • Columbia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Beck Depression Inventory	7 years
Beck Anxiety Inventory	7 years
Mental Health Inventory	7 years
Impact of Events Scale-Revised	7 years
Axis I Structured Clinical Interview for DSM-IV (SCID)	7 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Fear Structure	7 years
Brief COPE	7 years

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Collaborators: National Cancer Institute (NCI); Memorial Sloan Kettering Cancer Center; Columbia University; Icahn School of Medicine at Mount Sinai; Emory University; Weill Medical College of Cornell University; Children's Hospital Los Angeles; University of Medicine and Dentistry of New Jersey; National Marrow Donor Program
• Investigators: Principal Investigator: Sharon L Manne, Ph.D., Rutgers Cancer Institute of New Jersey

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: July 14, 2009
• First Submitted That Met QC Criteria: July 14, 2009
• First Posted (Estimate): July 15, 2009

Study Record Updates

• Last Update Posted (Estimate): March 10, 2016
• Last Update Submitted That Met QC Criteria: March 9, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: depression; children; counseling; parents; hematopoietic stem cell transplant; bone marrow transplant
• Other Study ID Numbers: 130906; P30CA072720 (U.S. NIH Grant/Contract); 1R01CA127488-01A1 (U.S. NIH Grant/Contract); CDR0000632012 (Registry Identifier: PDQ (Physician Data Query)); FCCC-07848; 0220090280 (Other Identifier: IRB Number); IRB#07-848; 15032-01 (Other Identifier: Fox Chase number)