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

NCT00939380 | Completed

• 7 other identifiers: 1309061R01CA127488-01A1CDR0000632012FCCC-078480220090280P30CA072720IRB#07-848; 15032-01
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 5

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.

Conditions

Childhood Cancers

Keywords

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

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• Fear Structure

  7 years

• Brief COPE

  7 years

Study Arms (2)

P-SCIP

EXPERIMENTAL

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; Other: CD-ROM

BPC

EXPERIMENTAL

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; Other: Respite care

Interventions

Behavioral intervention sessions BEHAVIORAL

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.

P-SCIP

CD-ROM OTHER

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

P-SCIP

DVD and pamphlet OTHER

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.

BPC

Respite care OTHER

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

BPC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• pediatric patient has a diagnosis of medulloblastoma or other cancer of the brain

Sponsors & Collaborators

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

Study Sites (5)

Childrens Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Emory University/Childrens Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

Location

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 080903, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Columbia University

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Depression

Interventions

CD-ROM; Respite Care

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Compact Disks; Videodisc Recording; Optical Storage Devices; Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture; Television; Home Nursing; Nursing Care; Patient Care; Therapeutics; Home Care Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Sharon L Manne, Ph.D.

  Rutgers Cancer Institute of New Jersey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2009
• First Posted: July 15, 2009
• Study Start: May 1, 2010
• Primary Completion: January 1, 2015
• Study Completion: May 1, 2015
• Last Updated: March 10, 2016

Record last verified: 2016-03

Locations

US (5)