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Completed

NCT Number: NCT00645931

Psychological Effects of Bone Marrow Transplants in Children

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.

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Key information

Conditions

Psychological

Age range

1 day–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Helen DeVos Children's Hospital

Grand Rapids, Michigan, 49503, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • over the age of 18

Treatment and study plan

protein and calorie controlled diet and self-hypnotic relaxation

Behavioral

daily

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Corewell Health West

Other

Collaborators

  • Helen DeVos Children's Hospital

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2009
Study completion
2009
First posted
Mar 28, 2008
Registry last updated
Jun 2, 2023

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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