Psychological Effects of Bone Marrow Transplants in Children

This study has been completed.
Sponsor:
Collaborator:
Helen DeVos Children's Hospital
Information provided by:
Spectrum Health Hospitals
ClinicalTrials.gov Identifier:
NCT00645931
First received: March 25, 2008
Last updated: December 29, 2009
Last verified: December 2009
  Purpose

This study is designed to examine the psychological effects of bone marrow transplants on children and their families. The investigators hypothesis is that families who show signs of psychological distress before transplant will continue those signs post transplant. The investigators are examining cognitive placement, emotional placement and other psychological factors in both the child undergoing transplant and his or her parent.


Condition Intervention
Psychological
Behavioral: protein and calorie controlled diet and self-hypnotic relaxation

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Proposal for a Bone Marrow Transplant Pre, Post, and Long Term Psychological Evaluation Study.

Resource links provided by NLM:


Further study details as provided by Spectrum Health Hospitals:

Primary Outcome Measures:
  • The specific measure that will be used to determine the effect of the intervention(s). The description should included the time at which the measure will be taken. Examples: all cause mortality at one year; score on a depression rating scale at 6 weeks [ Time Frame: 1 year post transplant ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Other measures that will be used to evaluate the intervention(s), and that are specified in the protocol. The description should include the time at which the measures will be taken. Ex. cardiovascular mortality at 6 mos.; functional status at 4 wks [ Time Frame: 1 year post transplant ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: June 2004
Study Completion Date: December 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: protein and calorie controlled diet and self-hypnotic relaxation
    daily
Detailed Description:

Previous research on bone marrow transplants has conflicting results concerning the effects of maladjustment. The current research is conducted in consortium with DeVos Children's Hospital. Children receiving bone marrow transplants are assessed using the Child Behavior Check List (CBCL) and Cognitive based testing. Parents are assessed using the Parenting Stress Index (PSI). Children and parents are evaluated prior to transplant and then 50 days, 6 months, and one year post transplant. Descriptive statistics are currently being used to determine results.

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients under the age of 18

Criteria

Inclusion Criteria:

  • bone marrow transplant eligible patients
  • 18 years and under
  • male and female

Exclusion Criteria:

  • over the age of 18
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00645931

Locations
United States, Michigan
Helen DeVos Children's Hospital
Grand Rapids, Michigan, United States, 49503
Sponsors and Collaborators
Spectrum Health Hospitals
Helen DeVos Children's Hospital
Investigators
Principal Investigator: Heather Hammerstrom, BA Helen DeVos Children's Hospital
  More Information

No publications provided

Responsible Party: Heather L Hammerstrom, Spectrum Health
ClinicalTrials.gov Identifier: NCT00645931     History of Changes
Other Study ID Numbers: 2004-105, 2004-105
Study First Received: March 25, 2008
Last Updated: December 29, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Spectrum Health Hospitals:
Bone Marrow
Bone Marrow Transplant
Pediatric
Psychological Impact
Psychology

Additional relevant MeSH terms:
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 19, 2014