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Completed

NCT Number: NCT00939380

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Childrens Hospital Los Angeles, Los Angeles, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

CD-ROM

Other

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

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.

Respite care

Other

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

Primary outcomes

  1. Beck Depression Inventory

    Time frame: 7 years

  2. Beck Anxiety Inventory

    Time frame: 7 years

  3. Mental Health Inventory

    Time frame: 7 years

  4. Impact of Events Scale-Revised

    Time frame: 7 years

  5. Axis I Structured Clinical Interview for DSM-IV (SCID)

    Time frame: 7 years

Secondary outcomes

  1. Fear Structure

    Time frame: 7 years

  2. Brief COPE

    Time frame: 7 years

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Collaborators

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

Registry information

Acronym: P-SCIP

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Jul 15, 2009
Registry last updated
Mar 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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