Clinical trial NCT00939380: Facilitating Parent Adaptation to Pediatric Transplant: The P-SCIP Trial
Official title: Facilitating Parent Adaptation to Pediatric Transplant: The P-SCIP Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Cancers
Keywords: hematopoietic stem cell transplant
bone marrow transplant
children
parents
counseling
depression
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Children's Hospital Los Angeles
name: Columbia University
name: Emory University
name: Memorial Sloan Kettering Cancer Center
name: University of Medicine and Dentistry of New Jersey
name: Icahn School of Medicine at Mount Sinai
name: Weill Medical College of Cornell University
name: National Marrow Donor Program
First posted: 2009-07-15
Enrollment: 212
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Beck Depression Inventory
timeFrame: 7 years
measure: Beck Anxiety Inventory
timeFrame: 7 years
measure: Mental Health Inventory
timeFrame: 7 years
measure: Impact of Events Scale-Revised
timeFrame: 7 years
measure: Axis I Structured Clinical Interview for DSM-IV (SCID)
timeFrame: 7 years
Secondary outcomes:
measure: Fear Structure
timeFrame: 7 years
measure: Brief COPE
timeFrame: 7 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Childrens Hospital Los Angeles
state: California
city: Atlanta
country: United States
facility: Emory University/Childrens Healthcare of Atlanta
state: Georgia
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: New York
country: United States
facility: Columbia University
state: New York
Study officials:
affiliation: Rutgers Cancer Institute of New Jersey
name: Sharon L Manne, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: