Post-Traumatic Stress Symptoms (PTSS) in Transplant Recipients

NCT02892266 | Completed DMC

• 1 other identifier: DAIT CTOTC-11
• Study Type: observational
• Target: 124
• Locations: 1 country
• Sites: 13

Brief Summary

This study is conducted to better understand Post-Traumatic Stress Symptoms (PTSS) in adolescent transplant recipients and their parent/guardian and to see if PTSS play a role in the way adolescent transplant recipients take their prescribed medicine. Target population: medically stable adolescent solid organ (e.g., heart, kidney, liver, lung, small bowel) transplant recipients and their parent(s)/guardian.

Conditions

Solid Organ Transplant Recipients; Parent(s)/Guardian of Referenced Transplant Recipients

Keywords

Transplant recipients; Adolescents; Post-Traumatic Stress Symptoms (PTSS); Transplant Recipient and Family Impact(s)

Outcome Measures

Primary Outcomes (2)

• Medication Level Variability Index (MLVI)

  Defined by fluctuation in medication blood levels. Calculated as the standard deviation (variation) of a minimum of 3 outpatient tacrolimus trough levels, obtained for one year, consisting of 6 months prior to study enrollment plus 6 months post study enrollment.

  6 months retrospective data to 6 months post enrollment

• University of California at Los Angeles Post-Traumatic Stress Disorder Reaction Index DSM-5 (UCLA PTSD RI DSM-5) Total Score

  The UCLA PTSD RI DSM-5 is a widely used and validated self-report questionnaire assessing posttraumatic stress symptoms (PTSS) in children and adolescents ages 8-18 years.

  At enrollment visit

Secondary Outcomes (15)

• Above-threshold Medication Level Variability Index (MLVI)

  6 months post enrollment

• Above-threshold Child PTSS Score

  At enrollment visit

• Child Avoidance Score

  At enrollment visit

• Parent PTSS Total Score

  At enrollment visit

• Parent Avoidance

  At enrollment visit

Other Outcomes (2)

• Exploratory Outcome: Dose of steroids

  At enrollment

• Exploratory Outcome: Presence of Donor Specific Antibodies (DSA)

  At enrollment Visit

Study Arms (1)

Adolescent Transplant Recipients

1. Questionnaire battery at enrollment (Participants and their parents/guardians) 2. Clinical data from patient's chart (6 months of retrospective data \& 6 months of prospective tacrolimus trough level data)

Other: Assessment of adherence, mental health, behavioral, quality of life and biological constructs

Interventions

Assessment of adherence, mental health, behavioral, quality of life and biological constructs OTHER

Adolescent Transplant Recipients

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Adolescent transplant recipients at risk for non-adherence and can reliably answer self-report questionnaires.

You may qualify if:

• The patient:
• and/or their parent(s)/guardian must be able to understand and provide informed consent in English or Spanish;
• is prescribed tacrolimus (either brand or generic formulation); and
• has been seen in the enrolling center's clinic at least twice in the last two years.

You may not qualify if:

• The patient:
• received a transplant less than 18 months prior to enrollment;
• has had more than one transplant (including marrow replacement);
• or their parent(s)/guardian has been diagnosed with severe intellectual disability as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5);
• is not medically stable or is hospitalized;
• is currently enrolled in a study that aims to improve adherence to medical recommendations;
• is receiving cognitive behavioral therapy for confirmed or suspected diagnosis of Post-Traumatic Stress Disorder (PTSD) at enrollment;
• is receiving psychotropic medications for a confirmed or suspected diagnosis of PTSD.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Clinical Trials in Organ Transplantation in Children: collaborator

Study Sites (13)

Ronald Reagan UCLA Medical Center: Pediatric Transplantation

Los Angeles, California, 90095, United States

Location

Lucile Salter Packard Children's Hospital at Stanford: Pediatric Transplantation

Palo Alto, California, 94304, United States

Location

UCSF Benioff Children's Hospital: Pediatric Transplantation

San Francisco, California, 94143, United States

Location

University of Miami, Jackson Memorial Hospital: Pediatric Transplantation

Miami, Florida, 33136, United States

Location

Ann and Robert H. Lurie Children's Hospital of Chicago: Pediatric Transplantation

Chicago, Illinois, 60611, United States

Location

Boston Children's Hospital: Pediatric Transplantation

Boston, Massachusetts, 02215, United States

Location

St. Louis Children's Hospital: Pediatric Transplantation

St Louis, Missouri, 63110, United States

Location

Columbia University Medical Center: Pediatric Transplantation

New York, New York, 10032, United States

Location

Cincinnati Children's Hospital Medical Center: Pediatric Transplantation

Cincinnati, Ohio, 45229, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Children's Hospital of Philadelphia: Pediatric Transplantation

Philadelphia, Pennsylvania, 19104, United States

Location

University of Texas Southwestern/Children's Medical Center: Pediatric Transplantation

Dallas, Texas, 75235, United States

Location

Texas Children's Hospital: Pediatric Transplantation

Houston, Texas, 77030, United States

Location

Related Links

• The National Institute of Allergy and Infectious Diseases (NIAID)
• Division of Allergy, Immunology, and Transplantation (DAIT)
• The Clinical Trials in Organ Transplantation in Children (CTOT-C)

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood

MeSH Terms

Interventions

Mental Health; Quality of Life

Intervention Hierarchy (Ancestors)

Health; Population Characteristics; Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Stuart Sweet, M.D., Ph.D.

  St. Louis Children's Hospital: Pediatric Transplantation

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2016
• First Posted: September 8, 2016
• Study Start: September 1, 2016
• Primary Completion: November 24, 2018
• Study Completion: November 24, 2018
• Last Updated: January 7, 2019

Record last verified: 2019-01

Locations

US (13)