Trial Information

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

OBJECTIVES:

Primary

- To evaluate the relative impact of the Parent Social-Cognitive Intervention Program
(P-SCIP) vs the Best-Recommended Psychosocial Care (BPC) interventions on parent short-
and long-term psychological distress.

- To evaluate parent personal resources as well as child medical course variables that
contribute to intervention response.

Secondary

- To examine differential effects of P-SCIP vs BPC on parent social and cognitive
processing.

- To investigate barriers to participation in the intervention trial.

OUTLINE: This is a multicenter study.

Participants are stratified according to caregiving parent status (father vs mother), study
center, and primary parent caregiver language at CHLA vs Columbia (English vs Spanish).
Participants are randomized to 1 of 2 intervention arms.

- 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.

- 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.

Participants are assessed periodically by demographic information, hospitalization for
emotional problems, psychosocial services (i.e., religious counseling, professional
counseling, attending a support or therapy group, and other support services in the past
month), psychosocial care services during the child's HSCT hospitalization, psychotropic
medications and sleep medications taken, optimism by the Life Orientation Test, enacted
social support, informational support from medical team, treatment Expectancy, Working
Alliance Inventory, homework adherence (P-SCIP only), utilization of the CD-ROM/DVD, use of
offer of respite care by Child Life Specialist (BPC only), psychosocial and supportive care
available at site, and mental health services by the Awareness and Barriers to
Counseling-Revised questionnaire.

After completion of study intervention, participants are followed up at 1, 6, and 12 months.