Ignite Creation Date:
2025-12-24 @ 9:18 PM
Ignite Modification Date:
2025-12-29 @ 1:58 AM
Study NCT ID:
NCT01778504
Status:
RECRUITING
Last Update Posted:
2025-12-24
First Post:
2013-01-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Studying Childhood-onset Behavioral, Psychiatric, and Developmental Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001321', 'term': 'Autistic Disorder'}, {'id': 'D007859', 'term': 'Learning Disabilities'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}], 'ancestors': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}, {'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D003147', 'term': 'Communication Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-12-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07-08', 'lastUpdateSubmitDate': '2025-12-23', 'studyFirstSubmitDate': '2013-01-26', 'studyFirstSubmitQcDate': '2013-01-26', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-01-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2029-02-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clinical assessments', 'timeFrame': 'Ongoing', 'description': 'to evaluate correlates of clinical symptomatology and response to standard therapeutic interventions.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Natural History Study', 'Mental Illness', 'Autism', 'Developmental Delay', 'Genetic Disorder', 'Natural History'], 'conditions': ['Neuropsychiatric Disorder', 'Neurological Disorder', 'Neurodevelopmental Disorder', 'Sleep']}, 'referencesModule': {'references': [{'pmid': '1528956', 'type': 'BACKGROUND', 'citation': 'Beneke M, Rasmus W. "Clinical Global Impressions" (ECDEU): some critical comments. Pharmacopsychiatry. 1992 Jul;25(4):171-6. doi: 10.1055/s-2007-1014401.'}, {'pmid': '11055459', 'type': 'BACKGROUND', 'citation': 'Bodfish JW, Symons FJ, Parker DE, Lewis MH. Varieties of repetitive behavior in autism: comparisons to mental retardation. J Autism Dev Disord. 2000 Jun;30(3):237-43. doi: 10.1023/a:1005596502855.'}, {'pmid': '12959421', 'type': 'BACKGROUND', 'citation': 'Constantino JN, Davis SA, Todd RD, Schindler MK, Gross MM, Brophy SL, Metzger LM, Shoushtari CS, Splinter R, Reich W. Validation of a brief quantitative measure of autistic traits: comparison of the social responsiveness scale with the autism diagnostic interview-revised. J Autism Dev Disord. 2003 Aug;33(4):427-33. doi: 10.1023/a:1025014929212.'}, {'pmid': '30921255', 'type': 'DERIVED', 'citation': "Witmer C, Mattingly A, D'Souza P, Thurm A, Hadigan C. Incontinence in Phelan-McDermid Syndrome. J Pediatr Gastroenterol Nutr. 2019 Aug;69(2):e39-e42. doi: 10.1097/MPG.0000000000002342."}, {'pmid': '29402632', 'type': 'DERIVED', 'citation': "Khan OI, Zhou X, Leon J, Kessler R, Gaughan T, D'Souza P, Gropman A, Cohen N, Rennert O, Buckley A, Inati S, Thurm A. Prospective longitudinal overnight video-EEG evaluation in Phelan-McDermid Syndrome. Epilepsy Behav. 2018 Mar;80:312-320. doi: 10.1016/j.yebeh.2017.11.034. Epub 2018 Feb 3."}, {'pmid': '29265961', 'type': 'DERIVED', 'citation': 'Soorya L, Leon J, Trelles MP, Thurm A. Framework for assessing individuals with rare genetic disorders associated with profound intellectual and multiple disabilities (PIMD): the example of Phelan McDermid Syndrome. Clin Neuropsychol. 2018 Aug-Oct;32(7):1226-1255. doi: 10.1080/13854046.2017.1413211. Epub 2017 Dec 21.'}, {'pmid': '27166296', 'type': 'DERIVED', 'citation': 'Gaughan T, Buckley A, Hommer R, Grant P, Williams K, Leckman JF, Swedo SE. Rapid Eye Movement Sleep Abnormalities in Children with Pediatric Acute-Onset Neuropsychiatric Syndrome (PANS). J Clin Sleep Med. 2016 Jul 15;12(7):1027-32. doi: 10.5664/jcsm.5942.'}], 'seeAlsoLinks': [{'url': 'https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_2013-M-0028.html', 'label': 'NIH Clinical Center Detailed Web Page'}]}, 'descriptionModule': {'briefSummary': 'Background:\n\n\\- Many psychiatric, behavioral, and developmental disorders are genetic. This means that they tend to run in families. Some begin in childhood, while others do not appear until adulthood. Researchers want to look at people of all ages who have these disorders that started in childhood. They will also look at relatives of people with these disorders. This information will allow doctors to learn more about childhood behavioral problems and how they are inherited. It may also help doctors treat those disorders.\n\nObjectives:\n\n\\- To study the onset and treatment of childhood behavioral, psychiatric, and developmental disorders.\n\nEligibility:\n\n* Individuals of any age who have a psychiatric, autism spectrum, or developmental disorder, or other behavioral problems.\n* Family members of individuals with the above disorders. This group may include parents, grandparents, siblings, aunts/uncles, cousins, and children.\n\nDesign:\n\n\\- Participants will be screened with a medical history and physical exam. They may have a psychiatric history with tests of thinking, judgment, and behavior. Brain imaging scans may be performed to look at brain function....', 'detailedDescription': 'This is a diagnostic protocol designed to provide opportunities for identifying new clinical syndromes and permitting longitudinal assessments of a variety of childhood behavioral, psychiatric and developmental disorders. Disorders of particular interest are: autism, disorders of social cognition and other neurodevelopmental disorders; childhood psychiatric disorders and particularly those with acute symptom onset; and unique clinical presentations of pediatric behavioral syndromes, such as those associated with genetic disorders or those with a unique family history.\n\nObjectives: The primary objective of this protocol is to evaluate a variety of behavioral, neuropsychiatric, and neurodevelopmental conditions. The protocol will allow OCD investigators to gain additional knowledge about the course of various childhood behavioral syndromes. The information obtained is expected to generate questions to be answered and hypotheses to be tested in future protocols.\n\nStudy Population: The number of participants to be enrolled will be set up to 1,000 probands (children, adolescents and adults).\n\nDesign: This is a natural history protocol. The cross-sectional portion of this study may include in-depth medical, sleep and neurodevelopmental assessments to evaluate the relationship of biological abnormalities with neuropsychiatric symptomatology. Standard therapeutic interventions may be utilized to evaluate their effects in well-characterized participants with unique clinical presentations. Participants also may be asked to return to NIH for periodic follow-up assessments, in order to facilitate the longitudinal assessment of natural and treated courses of illness as a means of better understanding their progression and pathophysiology.\n\nOutcome Measures: No formal outcomes will be measured; however, the clinical assessments of enrolled participants may be used to evaluate correlates of clinical symptomatology and response to standard therapeutic interventions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '1 Day', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Up to 1000 people with psychiatric, behavioral, or developmental disorders will be enrolled in this study.', 'healthyVolunteers': True, 'eligibilityCriteria': '* INCLUSION CRITERIA:\n\nParticipants will be eligible if they:\n\n1. Are aged birth to 99 years\n2. Have a diagnosed or undiagnosed neuropsychiatric disorder, neurodevelopmental disability or abnormal behaviors.\n3. Have the ability to understand and sign an informed consent on behalf of themselves or their minor children, or have a legal guardian (or designated DPA).\n4. Are under the care of a primary physician.\n\nEXCLUSION CRITERIA:\n\nParticipants will not be eligible if they:\n\n* Are unwilling or unable to be evaluated and followed as clinically indicated. Examples might include children with severe behavioral problems who refuse physical examination.\n* The participant does not have a primary healthcare provider.'}, 'identificationModule': {'nctId': 'NCT01778504', 'briefTitle': 'Studying Childhood-onset Behavioral, Psychiatric, and Developmental Disorders', 'organization': {'class': 'NIH', 'fullName': 'National Institutes of Health Clinical Center (CC)'}, 'officialTitle': 'Diagnosis of Childhood-onset Behavioral Disorders, Neuropsychiatric Disorders and Neurodevelopmental Disorders', 'orgStudyIdInfo': {'id': '130028'}, 'secondaryIdInfos': [{'id': '13-M-0028'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Probands', 'description': 'Children, adolescents, and adults'}, {'label': 'Relatives of Probands', 'description': '1st, 2nd, and 3rd degree relatives'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20892', 'city': 'Bethesda', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)', 'role': 'CONTACT', 'email': 'ccopr@nih.gov', 'phone': '800-411-1222', 'phoneExt': 'TTY dial 711'}], 'facility': 'National Institutes of Health Clinical Center', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}], 'centralContacts': [{'name': 'Jessica M Vaughan, C.R.N.P.', 'role': 'CONTACT', 'email': 'jessica.vaughan@nih.gov', 'phone': '(301) 435-7958'}, {'name': 'Ashura W Buckley, M.D.', 'role': 'CONTACT', 'email': 'shu.buckley@nih.gov', 'phone': '(301) 496-5190'}], 'overallOfficials': [{'name': 'Ashura W Buckley, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Institute of Mental Health (NIMH)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}