[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT00271622":3,"trial-entities:NCT00271622":107,"trial-summary:NCT00271622":114},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":9,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":22,"study_type":31,"primary_purpose":9,"phases":32,"enrollment_info":33,"interventions":36,"primary_outcomes":37,"secondary_outcomes":41,"sex":42,"minimum_age":43,"maximum_age":9,"healthy_volunteers":44,"eligibility_criteria":45,"std_ages":53,"locations":57,"central_contacts":74,"overall_officials":83,"references":86,"see_also_links":103},"NCT00271622","060065","The Neurodevelopmental and Behavioral Phenotyping Screening Protocol","Neurodevelopmental and Behavioral Phenotyping Screening Protocol","RECRUITING",null,"2026-06-23","2026-08-24","2006-02-27","National Institute of Mental Health (NIMH)","NIH","The purpose of this protocol is to allow for the careful evaluation of healthy volunteers and individuals with risk for psychiatric disorders or neurodevelopmental disorders, such as autism spectrum disorder for specific protocols at NIH.","The purpose of this protocol is to allow for the careful evaluation of healthy volunteers and individuals with risk for psychiatric disorders or neurodevelopmental disorders, such as autism spectrum disorders. The evaluations may be used to determine if the participant meets criteria for participation in research protocols at the National Institute of Mental Health (NIMH) and other collaborative investigations. Since the entry criteria for these protocols vary, the screening evaluations will also vary. Behavioral evaluations will also be done through this protocol for individuals participating in IRB-approved protocols being conducted by collaborating scientists at NIH. The evaluations might include: a psychiatric interview; a diagnostic interview; developmental and\u002For cognitive testing; ratings of other psychiatric symptoms; neuropsychological testing; a medical history; a physical exam; blood; and a request for medical records. Parents of minors will be interviewed.",[18,19,20,21],"Neurologic Disorders","Autism","Neurodegenerative Disease","Neurobehavioral Manifestation",[23,24,25,26,27,28,29,30],"Developmental Delay","Pediatric","Pervasive Developmental Disorder","Early Development","Healthy Control Subjects","Autism Spectrum Disorders","Healthy Volunteer","HV","OBSERVATIONAL",[],{"count":34,"type":35},5000,"ESTIMATED",[],[38],{"measure":39,"description":39,"timeFrame":40},"Screening evaluations such as a psychiatric interview; a diagnostic interview; developmental and\u002For cognitive testing; ratings of other psychiatric symptoms","Ongoing",[],"ALL","6 Weeks",true,{"inclusion":46,"exclusion":50,"raw_text":52},[47,48,49],"Subjects must be at least 6 weeks of age.","Subjects or their parents must be competent to comprehend the purpose of the screening process and to provide written informed consent. Parents\u002Fguardians will sign the consent form, and both minors and adults (depending on results of capacity assessment) will be asked to assent only if it is determined that they understand their role in the study.","Subjects must be willing to undergo an evaluation which may include a psychiatric interview; and medical, neurological, and laboratory examinations (as appropriate, such as renal and liver function tests, serum electrolytes, urinalysis, blood levels of psychotropic drugs, and urine drug screen for the presence of psychoactive drugs and drugs of abuse, as determined on a subject-to-subject basis).",[51],"Lack of appropriate consent: For minor patients, consent must be obtained from all legal guardians\u002Fcaretakers, including both parents in separated or divorced families where there is shared legal custody of the child. In such cases, both parents must consent to the child s participation in this protocol.","* INCLUSION CRITERIA:\n* Subjects must be at least 6 weeks of age.\n* Subjects or their parents must be competent to comprehend the purpose of the screening process and to provide written informed consent. Parents\u002Fguardians will sign the consent form, and both minors and adults (depending on results of capacity assessment) will be asked to assent only if it is determined that they understand their role in the study.\n* Subjects must be willing to undergo an evaluation which may include a psychiatric interview; and medical, neurological, and laboratory examinations (as appropriate, such as renal and liver function tests, serum electrolytes, urinalysis, blood levels of psychotropic drugs, and urine drug screen for the presence of psychoactive drugs and drugs of abuse, as determined on a subject-to-subject basis).\n\nEXCLUSION CRITERIA:\n\n-Lack of appropriate consent: For minor patients, consent must be obtained from all legal guardians\u002Fcaretakers, including both parents in separated or divorced families where there is shared legal custody of the child. In such cases, both parents must consent to the child s participation in this protocol.",[54,55,56],"CHILD","ADULT","OLDER_ADULT",[58],{"facility":59,"status":8,"city":60,"state":61,"zip":62,"country":63,"contacts":64,"geoPoint":71},"National Institutes of Health Clinical Center","Bethesda","Maryland","20892","United States",[65],{"name":66,"role":67,"phone":68,"phoneExt":69,"email":70},"For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)","CONTACT","800-411-1222","TTY dial 711","ccopr@nih.gov",{"lat":72,"lon":73},38.98067,-77.10026,[75,79],{"name":76,"role":67,"phone":77,"email":78},"Margaret J Pekar","(301) 435-7962","pekarm@mail.nih.gov",{"name":80,"role":67,"phone":81,"email":82},"Genalynne C Mooneyham, M.D.","(301) 435-6651","gena.mooneyham@nih.gov",[84],{"name":80,"affiliation":13,"role":85},"PRINCIPAL_INVESTIGATOR",[87,91,94,97,100],{"pmid":88,"type":89,"citation":90},"31657503","DERIVED","Farmer C, Adedipe D, Bal VH, Chlebowski C, Thurm A. Concordance of the Vineland Adaptive Behavior Scales, second and third editions. J Intellect Disabil Res. 2020 Jan;64(1):18-26. doi: 10.1111\u002Fjir.12691. Epub 2019 Oct 28.",{"pmid":92,"type":89,"citation":93},"28120370","Manwaring SS, Mead DL, Swineford L, Thurm A. Modelling gesture use and early language development in autism spectrum disorder. Int J Lang Commun Disord. 2017 Sep;52(5):637-651. doi: 10.1111\u002F1460-6984.12308. Epub 2017 Jan 24.",{"pmid":95,"type":89,"citation":96},"25894712","Swineford LB, Guthrie W, Thurm A. Convergent and divergent validity of the Mullen Scales of Early Learning in young children with and without autism spectrum disorder. Psychol Assess. 2015 Dec;27(4):1364-78. doi: 10.1037\u002Fpas0000116. Epub 2015 Apr 20.",{"pmid":98,"type":89,"citation":99},"24274034","Thurm A, Manwaring SS, Luckenbaugh DA, Lord C, Swedo SE. Patterns of skill attainment and loss in young children with autism. Dev Psychopathol. 2014 Feb;26(1):203-14. doi: 10.1017\u002FS0954579413000874. Epub 2013 Nov 25.",{"pmid":101,"type":89,"citation":102},"23868881","Joseph L, Thurm A, Farmer C, Shumway S. Repetitive behavior and restricted interests in young children with autism: comparisons with controls and stability over 2 years. Autism Res. 2013 Dec;6(6):584-95. doi: 10.1002\u002Faur.1316. Epub 2013 Jul 18.",[104],{"label":105,"url":106},"NIH Clinical Center Detailed Web Page","https:\u002F\u002Fclinicalstudies.info.nih.gov\u002Fcgi\u002Fdetail.cgi?A_2006-M-0065.html",{"nct_id":4,"conditions":108,"biomarkers":113},[109,110,23,29,111,112],"Autism Spectrum Disorder","Degenerative Disease of Nervous System, Unspecified","Nervous System Disorder","Neurobehavioral Manifestations",[],{"nct_id":4,"found":44,"summary":115,"prompt_version":124},{"design":116,"status":117,"heading":7,"summary":118,"follow_up":119,"word_count":120,"commitments":121,"compensation":122,"drugs_mentioned":123},"This is an observational study, meaning no specific intervention is being tested. It plans to enroll up to 5000 participants.","completed","This study is looking for healthy volunteers and individuals at risk for mental health conditions or neurodevelopmental disorders, like autism spectrum disorder. The goal is to carefully evaluate participants to see if they might be a good fit for other research studies at the National Institute of Mental Health (NIH). You would undergo various evaluations, which could include interviews about your mental health and development, cognitive (thinking) tests, and a medical history. The study is open to people aged 6 weeks and older, of all genders. The success of this study is measured by these ongoing screening evaluations.","The primary evaluations are measured as ongoing, suggesting continuous assessment rather than a fixed follow-up period after treatment.",98,"You would undergo screening evaluations, which may include interviews, developmental\u002Fcognitive testing, and a medical history. Some evaluations might also involve neuropsychological testing, a physical exam, blood tests, and a request for medical records.","Not stated in the trial record.",[],"v2"]