Facilitating Parent Adaptation to Pediatric Transplant: The P-SCIP Trial
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Childhood Cancers |
Behavioral: P-SCIP Behavioral: BPC |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Facilitating Parent Adaptation to Pediatric Transplant: The P-SCIP Trial |
- Beck Depression Inventory [ Time Frame: Baseline, 1 month post-baseline, 6 mos post-baseline, 12 mos post-baseline ] [ Designated as safety issue: No ]
- Beck Anxiety Inventory [ Time Frame: Baseline, 1 month post-baseline, 6 mos post-baseline, 12 mos post-baseline ] [ Designated as safety issue: No ]
- Mental Health Inventory [ Time Frame: Baseline, 1 month post-baseline, 6 mos post-baseline, 12 mos post-baseline ] [ Designated as safety issue: No ]
- Impact of Events Scale-Revised [ Time Frame: Baseline, 1 month post-baseline, 6 mos post-baseline, 12 mos post-baseline ] [ Designated as safety issue: No ]
- Axis I Structured Clinical Interview for DSM-IV (SCID) [ Time Frame: Mood & Anxiety Modules at Baseline and 6 mo f/u; PTSD module at 6 mo f/u ] [ Designated as safety issue: No ]
- Fear Structure [ Time Frame: Baseline, 1 month post-baseline, 12 months post-baseline ] [ Designated as safety issue: No ]
- Brief COPE [ Time Frame: Baseline, 1 month post-baseline, 12 mos post-baseline ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 312 |
| Study Start Date: | August 2008 |
| Estimated Study Completion Date: | August 2013 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: P-SCIP
Consists of 5 60-minute counseling sessions. Sessions will begin immediately upon hospital admission. Session will occur over a three-week time span as some children are discharged 3 weeks after HSCT. The primary emphasis is learning how to engage in effective social and cognitive processing to deal with fears and worries about the transplant and transplant-related concerns.
|
Behavioral: P-SCIP
5 60-minute sessions with an interventionist
|
|
Experimental: BPC
BPC will consist of the available care at each site, a DVD and pamphlet describing psychological issues associated with HSCT and a booklet describing caregiver issues during HSCT and advice on how to handle them. An interventionist will meet with the parent to provide him/her with a walkie-talkie, description of five hours of respite care from a child life specialist, and a laptop to view the DVD.
|
Behavioral: BPC
Brief meeting with parent to provide BPC materials
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- biological or foster parent of children under 18 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
Contacts and Locations| Contact: Tina M Gajda, M.A. | 732-235-6472 | gajdatm@umdnj.edu |
| United States, California | |
| Childrens Hospital Los Angeles | Recruiting |
| Los Angeles, California, United States, 90027 | |
| Contact: Octavio Zavala, B.S. 323-660-2450 ext 16362 ozavala@chla.usc.edu | |
| Contact: Brenda Quinonez-Garcia, M.S.W. 323-361-4933 BQuinonez@chla.usc.edu | |
| Principal Investigator: Ernest Katz, Ph.D. | |
| United States, Georgia | |
| Emory University/Childrens Healthcare of Atlanta | Recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Contact: Maxson Bonnie, M.S. 404-785-1242 Bonnie.maxson@choa.org | |
| Principal Investigator: Mee Laura, Ph.D. | |
| United States, New Jersey | |
| Umdnj Cinj | Recruiting |
| New Brunswick, New Jersey, United States, 080903 | |
| Contact: Tina M Gajda, M.S. 732-235-6472 gajdatm@umdnj.edu | |
| Contact: Sharon Manne, PhD 732-235-6759 mannesl@umdnj.edu | |
| Principal Investigator: Sharon L Manne, Ph.D. | |
| United States, New York | |
| Columbia University | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Mirko Savone, BA ms4750@columbia.edu | |
| Principal Investigator: Stephen Sands, Psy.D. | |
| Memorial Sloan-Kettering Cancer Center | Recruiting |
| New York, New York, United States, 10021 | |
| Contact: Caraline Craig, B.A. 646-888-0131 craigc@mskcc.org | |
| Principal Investigator: Bartell Abraham, M.D., M.B.A. | |
| Principal Investigator: | Sharon L Manne, Ph.D. | University of Medicine and Dentistry New Jersey |
More Information
No publications provided
| Responsible Party: | University of Medicine and Dentistry New Jersey |
| ClinicalTrials.gov Identifier: | NCT00939380 History of Changes |
| Other Study ID Numbers: | IRB#07-848; 15032-01, 1 R01 CA127488-01A1 |
| Study First Received: | July 14, 2009 |
| Last Updated: | May 8, 2013 |
| Health Authority: | United States: Institutional Review Board United States: Federal Government |
Keywords provided by University of Medicine and Dentistry New Jersey:
|
hematopoietic stem cell transplant bone marrow transplant children |
parents counseling depression |
ClinicalTrials.gov processed this record on June 17, 2013