Psychological Effects of Bone Marrow Transplants in Children

Psychological Clinical Trial

Official title:

Proposal for a Bone Marrow Transplant Pre, Post, and Long Term Psychological Evaluation Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00645931
• Other study ID #: 2004-105
• Secondary ID: 2004-105
• Status: Completed
• Start date: June 2004
• Est. completion date: December 2009

Study information

• Verified date: May 2023
• Source: Spectrum Health Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 18 Years

Eligibility

Inclusion Criteria:

• bone marrow transplant eligible patients

• 18 years and under

• male and female

Exclusion Criteria:

• over the age of 18

Related Conditions & MeSH terms

• Psychological

Intervention

Behavioral:
• protein and calorie controlled diet and self-hypnotic relaxation
daily

Locations

Country	Name	City	State
United States	Helen DeVos Children's Hospital	Grand Rapids	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Spectrum Health Hospitals	Helen DeVos Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		1 year post transplant
Secondary	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		1 year post transplant