Trial record 4 of 51 for:    Open Studies | "Craniofacial Abnormalities"

Study of Quality of Life in Freeman-Sheldon Syndrome and Related Conditions (FSS-QLS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Freeman-Sheldon Research Group, Inc.
Sponsor:
Information provided by (Responsible Party):
Freeman-Sheldon Research Group, Inc.
ClinicalTrials.gov Identifier:
NCT01307475
First received: February 27, 2011
Last updated: October 21, 2013
Last verified: October 2013
  Purpose

Freeman-Sheldon syndrome (FSS) is a rare human neuromusculoskeletal disorder present before birth, involving primarily limb and craniofacial deformities.

The hypotheses in the present study of FSS and related conditions are: (1) FSS and related conditions are associated with higher rates of posttraumatic stress symptoms (PTSS), depression, and reduced quality of life than is observed in the general population; (2) persons close to an individual with FSS or related condition suffer similarly; and (3) current measures, which are single-disease specific (i.e., PTSS, depression, craniofacial deformities, or limb deformities), do not capture the unique picture of FSS and related conditions, which involve both limb and craniofacial deformities in an intellectually capable individual.

There have been no studies looking at quality of life associated with FSS. Some authors have looked at quality of life in persons with facial differences; other authors have looked at bone and joint problems. Many other authors have looked at PTSS and depression caused by health problems and bad medical experiences. No authors have looked at these problems when they happen together, as they do in FSS. Because of the above, there may be differences in patients that have FSS versus patients in previous quality of life studies. The study will also develop and validate an outcomes-based quality of life survey for FSS and related conditions.


Condition Intervention
Arthrogryposis
Craniofacial Abnormalities
Posttraumatic Stress Disorder
Depressive Disorder
Other: PTSD Checklist-Specific
Other: Modified Flanagan Quality of Life Scale
Other: Center for Epidemiologic Studies Depression Scale
Other: Functional Enquiry Form
Other: Strength, Joint ROM, Girth and Length Measurements
Other: Study Physical Examination
Other: PTSD, Depression, and FSS-Focused Examination
Other: Freeman-Sheldon Specific Quality of Life Survey
Other: Lactate, Glucose, and Adenosine Triphosphate Blood Levels

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Freeman-Sheldon Syndrome Quality of Life Study (FSS-QLS): Cross-sectional, Cohort Study of Concomitant Disorder-Specific Contributors to Quality of Life and Clinical Outcome

Resource links provided by NLM:


Further study details as provided by Freeman-Sheldon Research Group, Inc.:

Primary Outcome Measures:
  • Situational Mental Health in Persons with FSS or Related Condition [ Time Frame: Evaluated during 1-2 study visits (lasting an average of 1-3 hours each) and in self-completed surveys, over an average of 2-4 years from enrolment ] [ Designated as safety issue: No ]
    Increased frequency of mental health symptoms and diagnoses (PTSS, Depression, and reduced quality of life) over expected for general population


Secondary Outcome Measures:
  • Situational Mental Health in Family and Others Close to a Person with FSS or Related Condition [ Time Frame: Evaluated during 1-2 study visits (lasting an average of 1-3 hours each) and in self-completed surveys, over an average of 2-4 years from enrolment ] [ Designated as safety issue: No ]
    Increased frequency of mental health symptoms and diagnoses (PTSS, Depression, and reduced quality of life) over expected for general population

  • Current Survey Correlation with Disorder-Specific Survey for FSS and Related Conditions [ Time Frame: Evaluated during 1-2 study visits (lasting an average of 1-3 hours each) and in self-completed surveys, over an average of 2-4 years from enrolment ] [ Designated as safety issue: No ]
    Ability of current surveys to capture full picture of quality of life for persons, families, and others affected by FSS and related conditions will be assessed to determine need for a disorder-specific survey and usefulness of existing surveys.


Biospecimen Retention:   None Retained

Blood samples will be taken but no retention is expected.


Estimated Enrollment: 20
Study Start Date: February 2011
Groups/Cohorts Assigned Interventions
Proband Group
Patients identified with FSS or a related condition
Other: PTSD Checklist-Specific
Completed by patients before clinical examination; it is a 17-item survey listing of symptoms of posttraumatic stress disorder.
Other Names:
  • PCL-S
  • PCL-C
  • PTSD Checklist-Civilian
Other: Modified Flanagan Quality of Life Scale
Completed by patients before clinical examination; it is a 16-item survey designed for use in persons with chronic illness.
Other Names:
  • QOLS
  • Flanagan Quality of Life Scale
  • Quality of Life Scale
Other: Center for Epidemiologic Studies Depression Scale
Completed by patients before clinical examination; it is a 20-item survey that asks about depressive feelings and behaviours in the past week.
Other Name: CES-D
Other: Functional Enquiry Form
Completed by patients before clinical examination; it is a checklist of medical problems.
Other Names:
  • FSRG Form 08
  • health history
  • review of systems
  • systems review
  • medical history
  • personal health history
Other: Strength, Joint ROM, Girth and Length Measurements
Completed during the clinical examination by the researchers, it is a structured approach to evaluation of muscles, joints, arms, thighs, and legs.
Other Names:
  • SF 527
  • Standard Form 527
  • musculoskeletal examination
  • musculoskeletal exam
  • musculoskeletal evaluation
  • musculoskeletal assessment
  • extremity examination
  • extremity evaluation
  • extremity assessment
  • extremity exam
Other: Study Physical Examination
Completed during the clinical examination by the researchers, it is a structured approach to a full physical examination, minus breasts, genitalia or rectum.
Other Names:
  • FSRG Form 14
  • physical examination
  • physical evaluation
  • physical assessment
  • medical examination
  • medical evaluation
  • medical assessment
  • full medical examination
  • full medical evaluation
  • full medical assessment
  • periodic medical examination
  • periodic medical evaluation
  • periodic medical assessment
  • annual medical examination
  • annual medical evaluation
  • annual medical assessment
  • yearly medical examination
  • yearly medical evaluation
  • yearly medical assessment
  • full physical examination
  • full physical evaluation
  • full physical assessment
  • complete physical examination
  • complete physical evaluation
  • complete physical assessment
  • yearly physical examination
  • yearly physical evaluation
  • yearly physical assessment
  • annual physical examination
  • annual physical evaluation
  • annual physical assessment
  • periodic physical examination
  • periodic physical evaluation
  • periodic physical assessment
  • screening physical examination
  • screening physical evaluation
  • screening physical assessment
  • screening physical
  • physical
  • periodic physical
  • annual physical
  • annual check-up
  • annual check up
  • yearly physical
  • yearly check up
  • yearly check-up
  • check up
  • check-up
  • medical check-up
  • medical check up
  • annual medical check-up
  • annual medical check up
  • yearly medical check-up
  • yearly medical check up
  • periodic medical check-up
  • periodic medical check up
  • periodic health evaluation
  • periodic health assessment
  • annual health evaluation
  • annual health assessment
  • yearly health evaluation
  • yearly health assessment
  • screening health evaluation
  • screening health assessment
  • screening medical examination
  • screening medical evaluation
  • screening medical assessment
  • med check
Other: PTSD, Depression, and FSS-Focused Examination
Completed during the clinical examination by the researchers, it is a structured approach to evaluation of symptoms, signs, and perceptions that may be related to FSS, PTSS, or depressive problems.
Other Names:
  • psychiatric examination
  • psychiatric evaluation
  • psychiatric assessment
  • diagnostic mental health examination
  • diagnostic mental health evaluation
  • diagnostic mental health assessment
  • diagnostic psychiatric examination
  • diagnostic psychiatric evaluation
  • diagnostic psychiatric assessment
  • intake examination
  • intake evaluation
  • intake assessment
  • mental health evaluation
  • mental health examination
  • mental health assessment
  • psychological examination
  • psychological evaluation
  • psychological assessment
  • psychological intake examination
  • psychological intake evaluation
  • psychological intake assessment
  • PTSD examination
  • PTSD evaluation
  • PTSD assessment
  • posttraumatic stress disorder evaluation
  • posttraumatic stress disorder examination
  • posttraumatic stress disorder assessment
  • post-traumatic stress disorder evaluation
  • post-traumatic stress disorder examination
  • post-traumatic stress disorder assessment
  • post traumatic stress disorder evaluation
  • post traumatic stress disorder examination
  • post traumatic stress disorder assessment
  • depression diagnostic examination
  • depression diagnostic evaluation
  • depression diagnostic assessment
  • depression evaluation
  • depression assessment
Other: Freeman-Sheldon Specific Quality of Life Survey
Completed after data analysis from the existing surveys and clinical examination, it will be a specific quality of life survey developed and tested during the study; it will take into consideration individual's total health outcome.
Other Names:
  • psychometric test development
  • psychometric testing
  • psychometric test validation
  • quality of life scale development
  • quality of life scale validation
  • quality of life survey development
  • quality of life survey validation
  • quality of life measure development
  • quality of life measure validation
Other: Lactate, Glucose, and Adenosine Triphosphate Blood Levels
Completed during the clinical examination by the researchers, lactate, glucose, and free and total adenosine triphosphate blood levels are determined at rest.
Other Names:
  • ATP levels
  • ATP blood levels
  • adenosine triphosphate test
  • blood test for ATP
  • blood test for adenosine triphosphate
  • ATP blood test
  • adenosine triphosphate blood test
  • ATP test
  • glucose test
  • glucose blood test
  • sugar test
  • lactic acid levels
  • lactic acid blood test
  • lactate blood test
  • lactate levels
Family Group
Persons who are genetically or legally related to a person with FSS or related condition
Other: PTSD Checklist-Specific
Completed by patients before clinical examination; it is a 17-item survey listing of symptoms of posttraumatic stress disorder.
Other Names:
  • PCL-S
  • PCL-C
  • PTSD Checklist-Civilian
Other: Modified Flanagan Quality of Life Scale
Completed by patients before clinical examination; it is a 16-item survey designed for use in persons with chronic illness.
Other Names:
  • QOLS
  • Flanagan Quality of Life Scale
  • Quality of Life Scale
Other: Center for Epidemiologic Studies Depression Scale
Completed by patients before clinical examination; it is a 20-item survey that asks about depressive feelings and behaviours in the past week.
Other Name: CES-D
Other: Functional Enquiry Form
Completed by patients before clinical examination; it is a checklist of medical problems.
Other Names:
  • FSRG Form 08
  • health history
  • review of systems
  • systems review
  • medical history
  • personal health history
Other: Strength, Joint ROM, Girth and Length Measurements
Completed during the clinical examination by the researchers, it is a structured approach to evaluation of muscles, joints, arms, thighs, and legs.
Other Names:
  • SF 527
  • Standard Form 527
  • musculoskeletal examination
  • musculoskeletal exam
  • musculoskeletal evaluation
  • musculoskeletal assessment
  • extremity examination
  • extremity evaluation
  • extremity assessment
  • extremity exam
Other: Study Physical Examination
Completed during the clinical examination by the researchers, it is a structured approach to a full physical examination, minus breasts, genitalia or rectum.
Other Names:
  • FSRG Form 14
  • physical examination
  • physical evaluation
  • physical assessment
  • medical examination
  • medical evaluation
  • medical assessment
  • full medical examination
  • full medical evaluation
  • full medical assessment
  • periodic medical examination
  • periodic medical evaluation
  • periodic medical assessment
  • annual medical examination
  • annual medical evaluation
  • annual medical assessment
  • yearly medical examination
  • yearly medical evaluation
  • yearly medical assessment
  • full physical examination
  • full physical evaluation
  • full physical assessment
  • complete physical examination
  • complete physical evaluation
  • complete physical assessment
  • yearly physical examination
  • yearly physical evaluation
  • yearly physical assessment
  • annual physical examination
  • annual physical evaluation
  • annual physical assessment
  • periodic physical examination
  • periodic physical evaluation
  • periodic physical assessment
  • screening physical examination
  • screening physical evaluation
  • screening physical assessment
  • screening physical
  • physical
  • periodic physical
  • annual physical
  • annual check-up
  • annual check up
  • yearly physical
  • yearly check up
  • yearly check-up
  • check up
  • check-up
  • medical check-up
  • medical check up
  • annual medical check-up
  • annual medical check up
  • yearly medical check-up
  • yearly medical check up
  • periodic medical check-up
  • periodic medical check up
  • periodic health evaluation
  • periodic health assessment
  • annual health evaluation
  • annual health assessment
  • yearly health evaluation
  • yearly health assessment
  • screening health evaluation
  • screening health assessment
  • screening medical examination
  • screening medical evaluation
  • screening medical assessment
  • med check
Other: PTSD, Depression, and FSS-Focused Examination
Completed during the clinical examination by the researchers, it is a structured approach to evaluation of symptoms, signs, and perceptions that may be related to FSS, PTSS, or depressive problems.
Other Names:
  • psychiatric examination
  • psychiatric evaluation
  • psychiatric assessment
  • diagnostic mental health examination
  • diagnostic mental health evaluation
  • diagnostic mental health assessment
  • diagnostic psychiatric examination
  • diagnostic psychiatric evaluation
  • diagnostic psychiatric assessment
  • intake examination
  • intake evaluation
  • intake assessment
  • mental health evaluation
  • mental health examination
  • mental health assessment
  • psychological examination
  • psychological evaluation
  • psychological assessment
  • psychological intake examination
  • psychological intake evaluation
  • psychological intake assessment
  • PTSD examination
  • PTSD evaluation
  • PTSD assessment
  • posttraumatic stress disorder evaluation
  • posttraumatic stress disorder examination
  • posttraumatic stress disorder assessment
  • post-traumatic stress disorder evaluation
  • post-traumatic stress disorder examination
  • post-traumatic stress disorder assessment
  • post traumatic stress disorder evaluation
  • post traumatic stress disorder examination
  • post traumatic stress disorder assessment
  • depression diagnostic examination
  • depression diagnostic evaluation
  • depression diagnostic assessment
  • depression evaluation
  • depression assessment
Other: Freeman-Sheldon Specific Quality of Life Survey
Completed after data analysis from the existing surveys and clinical examination, it will be a specific quality of life survey developed and tested during the study; it will take into consideration individual's total health outcome.
Other Names:
  • psychometric test development
  • psychometric testing
  • psychometric test validation
  • quality of life scale development
  • quality of life scale validation
  • quality of life survey development
  • quality of life survey validation
  • quality of life measure development
  • quality of life measure validation
Other: Lactate, Glucose, and Adenosine Triphosphate Blood Levels
Completed during the clinical examination by the researchers, lactate, glucose, and free and total adenosine triphosphate blood levels are determined at rest.
Other Names:
  • ATP levels
  • ATP blood levels
  • adenosine triphosphate test
  • blood test for ATP
  • blood test for adenosine triphosphate
  • ATP blood test
  • adenosine triphosphate blood test
  • ATP test
  • glucose test
  • glucose blood test
  • sugar test
  • lactic acid levels
  • lactic acid blood test
  • lactate blood test
  • lactate levels
Other Affected Individuals Group
Persons who have had significant and meaningful contact with a person with FSS or related condition but do not qualify for family group enrolment
Other: PTSD Checklist-Specific
Completed by patients before clinical examination; it is a 17-item survey listing of symptoms of posttraumatic stress disorder.
Other Names:
  • PCL-S
  • PCL-C
  • PTSD Checklist-Civilian
Other: Modified Flanagan Quality of Life Scale
Completed by patients before clinical examination; it is a 16-item survey designed for use in persons with chronic illness.
Other Names:
  • QOLS
  • Flanagan Quality of Life Scale
  • Quality of Life Scale
Other: Center for Epidemiologic Studies Depression Scale
Completed by patients before clinical examination; it is a 20-item survey that asks about depressive feelings and behaviours in the past week.
Other Name: CES-D
Other: Functional Enquiry Form
Completed by patients before clinical examination; it is a checklist of medical problems.
Other Names:
  • FSRG Form 08
  • health history
  • review of systems
  • systems review
  • medical history
  • personal health history
Other: Strength, Joint ROM, Girth and Length Measurements
Completed during the clinical examination by the researchers, it is a structured approach to evaluation of muscles, joints, arms, thighs, and legs.
Other Names:
  • SF 527
  • Standard Form 527
  • musculoskeletal examination
  • musculoskeletal exam
  • musculoskeletal evaluation
  • musculoskeletal assessment
  • extremity examination
  • extremity evaluation
  • extremity assessment
  • extremity exam
Other: Study Physical Examination
Completed during the clinical examination by the researchers, it is a structured approach to a full physical examination, minus breasts, genitalia or rectum.
Other Names:
  • FSRG Form 14
  • physical examination
  • physical evaluation
  • physical assessment
  • medical examination
  • medical evaluation
  • medical assessment
  • full medical examination
  • full medical evaluation
  • full medical assessment
  • periodic medical examination
  • periodic medical evaluation
  • periodic medical assessment
  • annual medical examination
  • annual medical evaluation
  • annual medical assessment
  • yearly medical examination
  • yearly medical evaluation
  • yearly medical assessment
  • full physical examination
  • full physical evaluation
  • full physical assessment
  • complete physical examination
  • complete physical evaluation
  • complete physical assessment
  • yearly physical examination
  • yearly physical evaluation
  • yearly physical assessment
  • annual physical examination
  • annual physical evaluation
  • annual physical assessment
  • periodic physical examination
  • periodic physical evaluation
  • periodic physical assessment
  • screening physical examination
  • screening physical evaluation
  • screening physical assessment
  • screening physical
  • physical
  • periodic physical
  • annual physical
  • annual check-up
  • annual check up
  • yearly physical
  • yearly check up
  • yearly check-up
  • check up
  • check-up
  • medical check-up
  • medical check up
  • annual medical check-up
  • annual medical check up
  • yearly medical check-up
  • yearly medical check up
  • periodic medical check-up
  • periodic medical check up
  • periodic health evaluation
  • periodic health assessment
  • annual health evaluation
  • annual health assessment
  • yearly health evaluation
  • yearly health assessment
  • screening health evaluation
  • screening health assessment
  • screening medical examination
  • screening medical evaluation
  • screening medical assessment
  • med check
Other: PTSD, Depression, and FSS-Focused Examination
Completed during the clinical examination by the researchers, it is a structured approach to evaluation of symptoms, signs, and perceptions that may be related to FSS, PTSS, or depressive problems.
Other Names:
  • psychiatric examination
  • psychiatric evaluation
  • psychiatric assessment
  • diagnostic mental health examination
  • diagnostic mental health evaluation
  • diagnostic mental health assessment
  • diagnostic psychiatric examination
  • diagnostic psychiatric evaluation
  • diagnostic psychiatric assessment
  • intake examination
  • intake evaluation
  • intake assessment
  • mental health evaluation
  • mental health examination
  • mental health assessment
  • psychological examination
  • psychological evaluation
  • psychological assessment
  • psychological intake examination
  • psychological intake evaluation
  • psychological intake assessment
  • PTSD examination
  • PTSD evaluation
  • PTSD assessment
  • posttraumatic stress disorder evaluation
  • posttraumatic stress disorder examination
  • posttraumatic stress disorder assessment
  • post-traumatic stress disorder evaluation
  • post-traumatic stress disorder examination
  • post-traumatic stress disorder assessment
  • post traumatic stress disorder evaluation
  • post traumatic stress disorder examination
  • post traumatic stress disorder assessment
  • depression diagnostic examination
  • depression diagnostic evaluation
  • depression diagnostic assessment
  • depression evaluation
  • depression assessment
Other: Freeman-Sheldon Specific Quality of Life Survey
Completed after data analysis from the existing surveys and clinical examination, it will be a specific quality of life survey developed and tested during the study; it will take into consideration individual's total health outcome.
Other Names:
  • psychometric test development
  • psychometric testing
  • psychometric test validation
  • quality of life scale development
  • quality of life scale validation
  • quality of life survey development
  • quality of life survey validation
  • quality of life measure development
  • quality of life measure validation
Other: Lactate, Glucose, and Adenosine Triphosphate Blood Levels
Completed during the clinical examination by the researchers, lactate, glucose, and free and total adenosine triphosphate blood levels are determined at rest.
Other Names:
  • ATP levels
  • ATP blood levels
  • adenosine triphosphate test
  • blood test for ATP
  • blood test for adenosine triphosphate
  • ATP blood test
  • adenosine triphosphate blood test
  • ATP test
  • glucose test
  • glucose blood test
  • sugar test
  • lactic acid levels
  • lactic acid blood test
  • lactate blood test
  • lactate levels

Detailed Description:

This study is a research project initiated by the research student (Mikaela I. Poling) and assisted by the clinical genetics fellow (Andrés Morales) in partial fulfilment the FSRG Foundation Programme, under approval, direction, and supervision of the study PI (Rodger J. McCormick) and Sub-Investigator (Richard A. Chamberlain).

Mental Health and Congenital Deformities:

Apajasalo et al. (1998) found significantly decreased health-related quality of life versus controls among adults and youth ages with chondrodysplasias. Differences in adult scores were in the areas of mobility, usual activities, and sexual activity and discomfort. Youth scores differed more in school and hobbies and friends and physical appearance. Didierjean-Pillet (2002) stressed concern for aesthetics of reconstruction in consideration of psychiatric impacts of congenital deformities in psychosocial functioning. Nagata et al. (2008) found that 20% of mothers with children operated on for congenital disease were likely to have post-traumatic stress disorder (PTSD). They found that pro-active, effective participation in the child's care may alleviate PTSS. Vitale et al. (2005) found quality of life survey scores among clubfoot patients compatible with age-matched controls, in agreement with Roye (2001), and not correlated to radiograph appearance. They advised quality of life survey scores be primary endpoint in determining therapeutic outcome. Engell et al. (2007) found significant post-operative improvement in the Short Form-12 Health Survey physical component scale in congenital clubbed-foot patients in the Danish Twin Registry. Vitale et al. (2001) observed that tailored quality of life scales were required for paediatric orthopaedic populations. Hawkins and Radcliffe (2006) concluded there was a lack of appropriate and validated PTSD measures for paediatric patients. Part of this problem of lacking validated paediatric PTSD measures was likely do to non-comprehensive Diagnostic and Statistical Manual of Mental Disorders IV Text-Revision criteria.

Relevance to Current Study:

Because FSS-related deformities were more comprehensive, treatment-resistant, and associated with poorer clinical outcome, quality of life studies not including a subset of FSS patients may not be appropriate in the more challenging clinical picture of FSS-related deformities. In many conditions, disorder-specific quality of life measures (QLM) showed increased sensitivity and specificity over general QLMs and were important therapeutic tools to assess efficacy of and prioritise interventions. Results of disorder-specific QLMs were important predictors of clinical outcome.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients, family, and others affected world-wide are welcome, so long as they are or have had significant and meaningful contact with a person who has a qualifying diagnosis.

Criteria

Inclusion Criteria:

  • Freeman-Sheldon syndrome,
  • Sheldon-Hall syndrome,
  • Distal arthrogryposis type 1, or
  • distal arthrogryposis type 3
  • Deceased probands with enough clinical information available to satisfy study requirements
  • Probands who participated in a prior Freeman-Sheldon Research Group (FSRG)-study are automatically accepted, since their diagnoses have been confirmed by FSRG clinical faculty.
  • Probands with a reported qualifying diagnosis, who have not participated in a prior FSRG-study, will be required to complete the complete a survey from a prior study and provide photographs and any requested medical records to confirm their diagnoses.
  • Family members and other close contacts may enrol, so long as they have either resided with or had substantial and prolonged contact with a proband, who has an FSRG-verified qualifying diagnosis. Investigators will make the final decision on a case-by-case basis, based on information provided.

Exclusion Criteria:

  • Patients with other anomalies, not having one of the above syndromes, will not be accepted.
  • Deceased probands will not be accepted for analysis, without enough clinical data available to satisfy study data collection requirements.
  • Patients or parents of minor children not willing to give consent will not be included.
  • Family members or other contacts that neither resided with nor had substantial and prolonged contact with the proband.
  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: NCT01307475

Contacts
Contact: Mikaela I Poling, BA 304-460-9038 poling_mi@fsrgroup.org
Contact: Andrés Morales, MD andresm452@outlook.com

Locations
United States, West Virginia
Freeman-Sheldon Research Group, Inc. Headquarters Recruiting
Buckhannon, West Virginia, United States, 26201
Contact: Mikaela I Poling, BA    304-460-9038    poling_mi@fsrgroup.org   
Principal Investigator: Rodger J McCormick, DEd, MS         
Sub-Investigator: Robert L Chamberlain, MD         
Sub-Investigator: Richard A Chamberlain, MSW         
Sub-Investigator: Mikaela I Poling, BA         
Guatemala
San Juan de Dios General Hospital Recruiting
Guatemala City, Guatemala
Contact: Andrés Morales, MD       andresm452@outlook.com   
Sub-Investigator: Andrés Morales, MD         
Sponsors and Collaborators
Freeman-Sheldon Research Group, Inc.
Investigators
Principal Investigator: Rodger J McCormick, DEd, MS Freeman-Sheldon Research Group, Inc.
Study Director: Richard A Chamberlain, MSW Freeman-Sheldon Research Group, Inc.
  More Information

Additional Information:
Publications:
Responsible Party: Freeman-Sheldon Research Group, Inc.
ClinicalTrials.gov Identifier: NCT01307475     History of Changes
Other Study ID Numbers: 000082, U1111-1120-5996
Study First Received: February 27, 2011
Last Updated: October 21, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Freeman-Sheldon Research Group, Inc.:
Chronic Post-Traumatic Stress Disorder
Delayed Onset Post-Traumatic Stress Disorder
Post-Traumatic Neuroses
Posttraumatic Neuroses
Post-Traumatic Stress Disorders
Posttraumatic Stress Disorders
PTSD
Post TraumaticStress Disorder
Endogenous Depression
Neurotic Depression
Depressive Syndrome
Melancholia
Depressive Neurosis
Unipolar Depression
Depressive Symptoms
Emotional Depression
Quality of Life

Additional relevant MeSH terms:
Craniofacial Abnormalities
Congenital Abnormalities
Arthrogryposis
Depressive Disorder
Depression
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Craniofacial Dysostosis
Joint Diseases
Musculoskeletal Diseases
Muscular Diseases
Musculoskeletal Abnormalities
Mood Disorders
Mental Disorders
Behavioral Symptoms
Anxiety Disorders
Dysostoses
Bone Diseases, Developmental
Bone Diseases
Adenosine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on July 23, 2014