Psychological Effects of Bone Marrow Transplants in Children

NCT ID: NCT00645931

Last Updated: 2023-06-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-06-30

Study Completion Date

2009-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Psychological

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

protein and calorie controlled diet and self-hypnotic relaxation

daily

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* over the age of 18
Minimum Eligible Age

1 Day

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Helen DeVos Children's Hospital

OTHER

Sponsor Role collaborator

Spectrum Health Hospitals

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Spectrum Health

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Heather Hammerstrom, BA

Role: PRINCIPAL_INVESTIGATOR

Helen DeVos Children's Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Helen DeVos Children's Hospital

Grand Rapids, Michigan, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2004-105

Identifier Type: -

Identifier Source: secondary_id

2004-105

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.