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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00939380
Acronym
P-SCIP
Enrollment
212
Registered
2009-07-15
Start date
2010-05-31
Completion date
2015-05-31
Last updated
2016-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Childhood Cancers

Keywords

hematopoietic stem cell transplant, bone marrow transplant, children, parents, counseling, depression

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.

Interventions

BEHAVIORALBehavioral 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.

OTHERCD-ROM

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

OTHERDVD 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.

OTHERRespite care

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

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Children's Hospital Los Angeles
CollaboratorOTHER
Columbia University
CollaboratorOTHER
Emory University
CollaboratorOTHER
Memorial Sloan Kettering Cancer Center
CollaboratorOTHER
University of Medicine and Dentistry of New Jersey
CollaboratorOTHER
Icahn School of Medicine at Mount Sinai
CollaboratorOTHER
Weill Medical College of Cornell University
CollaboratorOTHER
National Marrow Donor Program
CollaboratorOTHER
Rutgers, The State University of New Jersey
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Beck Anxiety Inventory7 years
Impact of Events Scale-Revised7 years
Axis I Structured Clinical Interview for DSM-IV (SCID)7 years
Beck Depression Inventory7 years
Mental Health Inventory7 years

Secondary

MeasureTime frame
Brief COPE7 years
Fear Structure7 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026