StudyFinder
Search Results Within Category "Intellectual/Developmental Disability"
21 Study Matches
Improving Academic and Social Functioning in Middle-Schoolers With Autism
Ellie Thoma - skillsbuilder@cchmc.org
ALL
10 years to 15 years old
NA
NCT06705907
Inclusion Criteria:
* Diagnosis of autism
* No intellectual disability
* Problems with organization, materials management, and planning and prioritization
* Problems with social skills
* Fully included in middle school
* Stable medication and behavioral treatment regime
Exclusion Criteria:
* Home schooled
* Severe co-occurring psychopathology (e.g., aggression, suicidal)
* Non English-speaking BEHAVIORAL: Achieving Independence and Mastery in School (AIMS), BEHAVIORAL: Building Essential Social Skills for Teens (BESST)
Autism, Autism Spectrum Disorder
social skills, executive functions, academic achievement, middle school
Rett Syndrome Registry (RSR)
Andrea Gonnella - Andrea.Gonnella@cchmc.org
ALL
0 years to 99 years old
NCT05432349
Inclusion Criteria:
* Male or female with a pathologic loss of function alteration of MECP2
Exclusion Criteria:
* Male or female with a gain of function alteration of MECP2, including those with MEPC2 duplication or triplication Rett Syndrome, Rett Syndrome, Atypical, Genetic Disease, Genetic Diseases, X-Linked, Intellectual Disability, Neurobehavioral Manifestations, Neurologic Manifestations, Neurologic Disorder, Neurodevelopmental Disorders, Nervous System Diseases
Rett syndrome, MECP2, Neurodevelopmental disorder, Registry, Natural History Study
Carboxylesterase 1 Genetic Variation and Methylphenidate in ADHD
Simon Abimosleh - simon.abimosleh@cchmc.org
ALL
6 years to 17 years old
PHASE4
NCT03781752
Inclusion Criteria:
\- Youth ages 6-17 years with ADHD as a primary diagnosis
Exclusion Criteria:
* Participants that do not have ADHD as a primary diagnosis
* Participants that do not want, require, or are not healthy enough for a single dose trial of MPH for ADHD per the clinical judgment of the treating and study clinicians
* Participants that are smokers or, are pregnant DRUG: Methylphenidate
ADHD, Attention Deficit Hyperactivity Disorder
PK Study, PD Study, Pharmacokinetics, Pharmacodynamics, Methylphenidate, MPH
Speech-in-noise Perception in Autism and Fragile X
Elizabeth Smith - elizabeth.smith3@cchmc.org
ALL
15 years to 35 years old
NA
NCT06088589
Inclusion Criteria:
• normal audiograms (PTA ≤ 20 dB HL)
• corrected 20/20 vision (Snellen chart)
• no history of premature birth (prior to 36 weeks gestation)
• no medications known to affect EEG signal
• English as the first language Inclusion for the Autism group requires the following: 1\) diagnosis of Autism Spectrum Disorder either based on previous ADOS administration and developmental history, or confirmed via ADOS and developmental history Inclusion for the Autism + FXS group requires the following:
• Documented PCR/Southern Blot genetic testing confirming full mutation FXS
• Diagnosis of Autism Spectrum Disorder, per Autism group. Inclusion for the Typically Developing group requires the following:
• no siblings or parents with an Autism Spectrum Disorder or Fragile X Syndrome
• no current neurological or psychiatric diagnoses
• IQ over 75
Exclusion Criteria:
* Hearing loss or uncorrected vision loss
* history of premature birth (prior to 36 weeks gestation) BEHAVIORAL: Mismatch negativity
Autism Spectrum Disorder, Fragile X Syndrome
The Pediatric Acute Leukemia (PedAL) Screening Trial - A Study to Test Bone Marrow and Blood in Children With Leukemia That Has Come Back After Treatment or Is Difficult to Treat - A Leukemia & Lymphoma Society and Children's Oncology Group Study
- cancer@cchmc.org
ALL
Up to 22 years old
PHASE1
NCT04726241
Inclusion Criteria:
* Patients must be less than 22 years of age at the time of study enrollment
* Patient must have one of the following at the time of study enrollment:
* Patient has known or suspected relapsed/refractory (including primary refractory) AML as defined in protocol
* This includes isolated myeloid sarcoma
* Patient has known or suspected relapsed/refractory (including primary refractory) myeloid leukemia of Down syndrome (ML-DS)
* Patient has known or suspected relapsed ALL as defined in protocol that meets one of the following criteria:
* Second or greater B-ALL medullary relapse, excluding KMT2Ar
* Any first or greater B-ALL medullary relapse involving KMT2Ar
* Any first or greater T-ALL medullary relapse with or without KMT2Ar
* Patient has known or suspected relapsed/refractory (including primary refractory) mixed phenotype acute leukemia (MPAL) as defined in protocol
* Patient has known or suspected de novo or relapsed/refractory (including primary refractory) treatment-related AML (t-AML)
* Patient has known or suspected de novo or relapsed/refractory (including primary refractory) myelodysplastic syndrome (MDS) or treatment-related myelodysplastic syndrome (t-MDS)
* Note: Relapsed/refractory disease includes stable disease, progressive disease, and disease relapse.
* Patient has known or suspected de novo or relapsed/refractory (including primary refractory) juvenile myelomonocytic leukemia (JMML)
* Note: Relapsed/refractory disease includes stable disease, progressive disease, and disease relapse.
* All patients and/or their parents or legal guardians must sign a written informed consent
* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met PROCEDURE: Biospecimen Collection
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Acute Myeloid Leukemia Post Cytotoxic Therapy, Juvenile Myelomonocytic Leukemia, Mixed Phenotype Acute Leukemia, Myelodysplastic Syndrome, Myelodysplastic Syndrome Post Cytotoxic Therapy, Myeloid Leukemia Associated With Down Syndrome
RASopathy Biorepository
Lindsey Aschbacher-Smith - lindsey.aschbacher-smith@cchmc.org
ALL
NCT04395495
Inclusion Criteria:
* Patients with a suspected or known diagnosis of any of the group of disorders known as RASopathies (e.g., Neurofibromatosis, Costello Syndrome, Noonan Syndrome). Diagnosis may be made clinically and/or confirmed through genetic testing.
* Unaffected relatives of patients with a suspected or known diagnosis of any of the group of disorders known as RASopathies.
Exclusion Criteria:
* Individuals who do not have a suspected or definite diagnosis of a RASopathy.
* Individuals who do not have a relative with a suspected or definite diagnosis of a RASopathy.
* Patients who do not have the ability/capacity to undergo the informed consent process OR whose parent/legal guardian is unable to undergo the informed consent process. RAS Mutation, Neurofibromatosis 1, Noonan Syndrome, Noonan Syndrome With Multiple Lentigines, Noonan Neurofibromatosis Syndrome, Cardiofaciocutaneous Syndrome, Costello Syndrome, Legius Syndrome, Smith-Kingsmore Syndrome, MTOR Gene Mutation, GATOR-1 Gene Mutation, SYNGAP1-Related Intellectual Disability, DLG4, MAPK1 Gene Mutation
Autism Doula Program Evaluation
Teresa Smith, PhD - teresa.smith@cchmc.org
ALL
18 months to 71 months old
NA
NCT06896942
Inclusion Criteria:
caregivers of children who are 18 months to five years and recently diagnosed with autism. Caregivers must identify as Black and be over the age of 18 and identify their children as Black. OTHER: Autism Doula, OTHER: DDBP Family Navigation
Health Equity, Autism Spectrum Disorder
health equity, autism spectrum disorder, family navigation
Treatment of Obstructive Sleep Apnea With Personalized Surgery in Children With Down Syndrome (TOPS-DS) (TOPS-DS)
Angie Duggins - angie.duggins@cchmc.org
ALL
2 years to 17 years old
NA
NCT05508971
Requirements to participate in study:
Child has a diagnosis of Down syndrome (Trisomy 21). Child has a diagnosis of moderate to severe OSA diagnosed by PSG (oAHI ≥ 5). Child age is 2.00 to 17.99 years of age. Caregiver can provide signed and dated consent and is 18 years of age or older at the time of consent.
Caregiver can speak, read, and write in English or Spanish. Caregiver is primary caretaker of the child. Child is not expecting their own child. Child is eligible for surgical treatment
Cannot participate in study if:
Child has history of previous tonsillectomy, tonsillotomy, or partial tonsillectomy.
Child has any contraindication to surgery (e.g. bleeding disorders). Child has significant cardiopulmonary comorbidity besides OSA requiring supplemental oxygen, subglottic or tracheal stenosis, tracheostomy dependence.
Caregiver is unwilling or unable to comply with study procedures. Child is or plans to have their own child.
PROCEDURE: DISE-Directed Surgery, PROCEDURE: Adenotonsillectomy
Obstructive Sleep Apnea, Down Syndrome
Alpha Auditory Entrainment for Cognitive Enhancement and Sensory Hypersensitivity in Youth With Developmental Disorders (ENTRAIN)
Jae Citarella - Jae.Citarella@cchmc.org
ALL
5 years to 10 years old
NA
NCT06227780
Inclusion Criteria:
* FXS Cohort: 1) Aged 5-10 years, inclusive; 2) Patient has full FMR1 mutation confirmed by genetic testing.
* ASD Cohort: 1) Aged 5-10 years, inclusive; 2) Have no known genetic mutation; 3) Have documentation of ASD diagnosis; 4) Score ≤ 15 on SCQ screen; 5) Be in good health per investigator.
* TDC Cohort: 1) Aged 5-10 years, inclusive; 2) Have no known genetic mutation; 3) Have documentation of ASD diagnosis; 4) Score ≤ 15 on SCQ screen; 5) Be in good health per investigator; 6) Patient has met normal developmental milestones; Patient has no family history of heritable neuropsychiatric disorders; 7) Patient has an IQ greater than 85 on the Stanford-Binet; 8) Score ≤8 on an SCQ screen.
Exclusion Criteria:
* All subjects: 1) Patient has auditory or visual impairments that cannot be corrected; 2) History of substance abuse or dependence within the past 6 months OTHER: Alpha Auditory Entrainment, OTHER: Sham
Fragile X Syndrome, Autism Spectrum Disorder, Autistic Disorder, Asperger Syndrome
Neurodevelopmental Disorders, Autistic Disorder, Autism Spectrum Disorder, Fragile X Syndrome, Fragile X, FXS, ASD, Asperger, Autism
A Study to Compare Blinatumomab Alone to Blinatumomab With Nivolumab in Patients Diagnosed With First Relapse B-Cell Acute Lymphoblastic Leukemia (B-ALL)
- cancer@cchmc.org
ALL
1 year to 30 years old
PHASE2
NCT04546399
Inclusion Criteria:
* Patients must be \>= 1 and \< 31 years at time of enrollment
* Patients must have first relapse of CD19+ B-ALL (relapse blasts must express CD19) in one of the following categories:
* Isolated bone marrow relapse
* Isolated central nervous system (CNS) (excluding known optic nerve/retinal and CNS chloromas) and/or testicular relapse
* Combined bone marrow with extramedullary relapse in the CNS (excluding known optic nerve/retinal and CNS chloromas) and/or testes
* Patients with Down syndrome (DS) are eligible in the following categories:
* Isolated bone marrow relapse
* Combined bone marrow with CNS (excluding known optic nerve/retinal and CNS chloromas) and/or testicular relapse
* Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients \> 16 years of age and Lansky for patients =\< 16 years of age
* Of note, for patients with developmental delay (e.g., Down syndrome) regardless of age, Lansky scale may be substituted for Karnofsky scale. However, the requirement for ECOG 0-2 remains, regardless of known history of developmental delay
* Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study
* Patients with prior blinatumomab or CD19+ chimeric antigen receptor therapy in the upfront setting will be eligible, provided relapsed lymphoblasts retain CD19 expression
* Patients must not have had a prior hematopoietic stem cell transplant
* A single intrathecal chemotherapy at the time of relapse will be allowed. If \< 7 days have elapsed between this intrathecal therapy (IT) and the start of protocol therapy, then the day 1 intrathecal chemotherapy (i.e. methotrexate, cytarabine, or triple intrathecal) may be omitted
* In the 28 days prior to enrollment, up to five days of post-relapse, pre-enrollment therapy (steroids and/or hydroxyurea only) is permissible
* Patients with Down syndrome who received pre-enrollment therapy and have a white blood count (WBC) \>= 30,000/ul at the time of enrollment still must receive protocol specified cytoreductive therapy with vincristine and dexamethasone, and no "washout" is required
* Patients with Down syndrome who received pre-enrollment therapy and have a WBC \< 30,000/ul at the time of enrollment must be given a 24 hour "washout" before starting immunotherapy
* Note: There is no waiting period or "washout" for patients who relapse while receiving upfront therapy
* Creatinine clearance or radioisotope glomerular filtration rate (GFR) \>= 70 mL/min/1.73 m\^2 OR a serum creatinine based on age/sex as follows (within 7 calendar days prior to enrollment):
* Age: Maximum serum creatinine (mg/dL)
* 1 to \< 2 years: 0.6 (male), 0.6 (female)
* 2 to \< 6 years: 0.8 (male), 0.8 (female)
* 6 to \< 10 years: 1 (male), 1 (female)
* 10 to \< 13 years: 1.2 (male), 1.2 (female)
* 13 to \< 16 years: 1.5 (male), 1.4 (female)
* \>= 16 years: 1.7 (male), 1.4 (female)
* The threshold creatinine values in this Table were derived from the Schwartz formula for estimating GFR utilizing child length and stature data published by the Center for Disease Control (CDC)
* Shortening fraction of \>= 27% by echocardiogram, or ejection fraction of \>= 50% by echocardiogram, cardiac magnetic resonance imaging (MRI) or radionuclide angiogram
* No evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry \> 94% if there is clinical indication for determination
* All patients and/or their parents or legal guardians must sign a written informed consent
* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Exclusion Criteria:
* Patients with B-lymphoblastic lymphoma (B-LLy)
* Patients with Burkitt leukemia/lymphoma or mature B-cell leukemia
* Patients with Philadelphia chromosome positive (Ph+) B-ALL or ABL class Ph-like B-ALL (i.e. rearrangements involving ABL1, ABL2, CSF1R or PDGFRB and predicted to be sensitive to imatinib or dasatinib)
* Patients with mixed phenotype acute leukemia (MPAL)
* Patients with known Charcot-Marie-Tooth disease
* Patients with known MYC translocation associated with mature (Burkitt) B-cell ALL, regardless of blast immunophenotype
* Patients with active, uncontrolled infection defined as:
* Positive bacterial blood culture within 48 hours of study enrollment
* Receiving IV or PO antibiotics for an infection with continued signs or symptoms. Note: Patients may be receiving IV or oral antibiotics to complete a course of therapy for a prior documented infection if cultures have been negative for at least 48 hours and signs or symptoms of active infection have resolved. For patients with clostridium (C.) difficile diarrhea, at least 72 hours of antibacterial therapy must have elapsed and stools must have normalized to baseline.
* Fever above 38.2 degrees Celsius (C) within 48 hours of study enrollment with clinical signs of infection. Fever without clinical signs of infection that is attributed to tumor burden is allowed if blood cultures are negative for \> 48 hours
* A positive fungal culture within 30 days of study enrollment or active therapy for presumed invasive fungal infection
* Active viral or protozoal infection requiring IV treatment
* Patients known to have one of the following concomitant genetic syndromes: Bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome are not eligible.
* Patients with uncontrolled HIV, hepatitis B, or hepatitis C infection. Of note, patients with known human immunodeficiency virus (HIV) infection on effective anti-retroviral therapy with undetectable viral load for at least the last 6 months prior to enrollment are eligible. Similarly, hepatitis B and hepatitis C positive patients who have been treated and have no viral detectable burden are also eligible
* Patients with significant central nervous system pathology that would preclude treatment with blinatumomab, including history of severe neurologic disorder or autoimmune disease with CNS involvement
* Note: Patients with a history of seizures that are well controlled on stable doses of anti-epileptic drugs are eligible Patients with a history of cerebrovascular ischemia/hemorrhage with residual deficits are not eligible. Patients with a history of cerebrovascular ischemia/hemorrhage remain eligible provided all neurologic deficits have resolved
* Patients with an active known/suspected autoimmune disease are not eligible. However, patients with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll
* Patients with DS patients with known non-hematopoietic, non-CNS/testicular extramedullary disease (i.e., chloromatous disease) are not eligible
* Note: Group 3 and 4 patients with known non-hematopoietic, non-CNS/testicular extramedullary disease (i.e., chloromatous disease) are eligible if this is NOT the only site of relapsed disease
* Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained within 7 days prior to enrollment. Patients who are sexually active and of reproductive potential are not eligible unless they agree to use an effective contraceptive method for the duration of this study. Men with female partners of childbearing potential should use effective contraception during the duration of their treatment. The effect of blinatumomab on fertility has not been evaluated. Blinatumomab is not recommended for pregnant women or women of childbearing potential (WOCBP) not using contraception. Females of reproductive potential must use effective contraception during treatment and for at least 48 hours after the last dose of blinatumomab. Studies in animal models have shown that nivolumab can adversely impair pregnancy. Thus, nivolumab is expected to cause fetal harm during pregnancy. WOCBP receiving nivolumab must continue contraception for a period of at least 5 months after the last dose of nivolumab. It is unknown whether nivolumab is present in breast milk, thus breastfeeding should be discontinued while a patient is receiving nivolumab
* Lactating females are not eligible unless they agree to not breastfeed their infants. It is unknown whether blinatumomab or its metabolites are excreted in human breast milk. Women are not permitted to breastfeed while receiving blinatumomab and for the last 48 hours after the last blinatumomab dose. Due to the potential for serious adverse reactions in the breastfed infant, women are not permitted to breastfeed during treatment and for 5 months after the last nivolumab dose RADIATION: 3-Dimensional Conformal Radiation Therapy, DRUG: Asparaginase Erwinia chrysanthemi, PROCEDURE: Biospecimen Collection, BIOLOGICAL: Blinatumomab, PROCEDURE: Bone Marrow Aspiration, PROCEDURE: Bone Marrow Biopsy, DRUG: Calaspargase Pegol, DRUG: Cytarabine, DRUG: Dexamethasone, DRUG: Hydrocortisone Sodium Succinate, PROCEDURE: Lumbar Puncture, DRUG: Mercaptopurine, DRUG: Methotrexate, BIOLOGICAL: Nivolumab, DRUG: Pegaspargase, DRUG: Vincristine Sulfate
Down Syndrome, Recurrent B Acute Lymphoblastic Leukemia
Tracking Early Emergence of Sound Perception Impairments in FXS With Multimodal fNIRS/EEG- Infant
Elizabeth Smith, PhD - elizabeth.smith3@cchmc.org
ALL
6 months to 26 months old
NA
NCT06560242
Inclusion Criteria:
* Diagnoses of Fragile X Syndrome, Typical Development, or History of Premature Birth
* able to sit independently
* English is spoken at home
Exclusion Criteria:
* For all participants: no seizures in the past 6 months
* For typical development group and Fragile X group: not born prior to 32 weeks gestation OTHER: Speech discrimination
Fragile X Syndrome
STRW-T Intervention for Autistic Adolescents in 11th and 12th Grade (STRW-T)
Carrie Fassler - carrie.fassler@cchmc.org
ALL
15 years to 21 years old
NA
NCT06552286
Inclusion Criteria:
* in the last 2 years of high school, or deferring graduation
* diagnosis of ASD based on clinical judgement and/or meeting the cut-off score on the Autism Diagnostic Observation Schedule, 2nd Edition
* full scale IQ of 70 or above as measured by the Wechsler Abbreviated Scale of Intelligence, 2nd Edition
* deficient Daily Living Skills as assessed by the Vineland Adaptive Behavior Scales, 3rd Edition - at least 1 of the 3 Daily Living Skills subdomains is at least 15 points below their full scale IQ
Exclusion Criteria:
* significant aggressive behaviors or mental health issues that require treatment out of the scope of the current intervention.
* if the adolescent has already completed the social skills group (PEERS), either at Cincinnati Children's or in another setting, unless it has been a significant amount of time since they did the PEERS group (2-3 years, or up to the discretion of the PI). BEHAVIORAL: STRW-T, BEHAVIORAL: PEERS-T
Autism Spectrum Disorder
Study of MRM-3379 in Male Participants With Fragile X Syndrome (BLOOM)
Hannah Sachs - Hannah.Sachs@cchmc.org
MALE
13 years to 45 years old
PHASE2
NCT07209462
Inclusion Criteria:
* Willing and able to provide signed informed consent/assent. Where local regulations permit inclusion of participants deemed unable to provide informed consent, a legally authorized representative must provide informed consent on the participant's behalf, and the participant must provide assent if applicable.
* Male, 13-45 years of age (inclusive)
* Weight ≥30 kg and BMI between 18 and 36 kg/m2 (inclusive) at the screening visit
* Diagnosis of FXS with a molecular genetic ≥200 CGG repetitions .
* Able to perform the PVT and ORRT of the NIH-TCB
* Have a consistent caregiver(s) who is willing and able to be present regularly and reliably with the participant
* Able to swallow tablets or capsules
Exclusion Criteria:
History of or current medical condition other than FXS and related issues that would place the participant at higher risk from study participation DRUG: Low dose of MRM-3379, DRUG: Middle Dose of MRM-3379, DRUG: High dose of MRM-3379, DRUG: Placebo, DRUG: Low dose of MRM-3379 Open-Label
Fragile X Syndrome
Fragile X Syndrome, FXS, FMR, Phosphodiesterase 4, PDE4
Down Syndrome Obstructive Sleep Apnea (DOSA)
Suzanna Hicks - suzanna.hicks@cchmc.org
ALL
5 years to 18 years old
PHASE2
NCT06043440
Inclusion Criteria:
• Ages 5.0 to 17.9 years at the time of screening
• Children with OSA and obstructive apnea hypopnea index (OAHI) ≥5/hour.
• Absence of clinically significant hypoxia defined as oxygen saturation \<88% for 5 minutes or episodic desaturation to 60% as these levels would otherwise identify children eligible to routinely receive oxygen.
• Favorable response to oxygen therapy (allowing randomization) will be defined as follows:
• Oxygen saturation nadir \>92% and
• Decrease in obstructive index \< 5 / hour or by \> 50% from screening PSG
• Reaching an optimum oxygen flow which is defined as the flow that achieves the lowest level of AHI with maximum CO2 level less than 65 mmHg observed for 5 consecutive minutes and or an increase in CO2 by less than 15 points above baseline. The above criteria are observed while the patient spends a minimal of 30 minutes in the supine position and at least one cycle of rapid eye movement (REM) sleep.
• Oxygen flow required does not exceed 3.0 LPM and does not exceed a FiO2 \> 40 %.
• Willingness to comply with all study procedures and available for duration of study.
• At baseline the participant attempts to perform the neuropsychological tests
Exclusion Criteria:
• Current CPAP use with documented compliance(\> 4 hrs/ night; \> 70% of nights).
• Oxygen saturation \< 90% at rest during wakefulness.
• Chronic daytime or nighttime use of supplemental oxygen.
• Smoker in the child's bedroom.
• Unrepaired congenital heart disease.
• Moderate to severe pulmonary hypertension requiring treatment with oxygen and or pulmonary vasodilator.
• Unable to participate in a PSG.
• Individuals who develop alveolar hypoventilation with oxygen as previously defined.
• Other severe chronic diseases determined by their provider as making them poor study candidates.
• Enrolled or planning to enroll in another study that may conflict with protocol requirements or confound results in this trial.
• Documented clinically significant untreated hypothyroidism
• Children with adenotonsillar hypertrophy who are candidates for adenotonsillectomy and parents agree to the surgery.
DRUG: Oxygen
Down Syndrome, Obstructive Sleep Apnea
Impact of Short and Mistimed Sleep on Adolescents With ADHD: The Adolescent Attention and Circadian Timing Study (AACT)
- teensleep@cchmc.org
ALL
13 years to 17 years old
NA
NCT07684417
Inclusion Criteria:
* Ages 13-17 years at time of informed consent/assent
* Based on semi-structured clinical interview, participants must meet full DSM-5 criteria for ADHD inattentive or ADHD combined presentation.
Exclusion Criteria:
* Non-traditional school setting (morning-afternoon Monday-Friday).
* Exclusionary diagnoses. We will exclude adolescents with known intellectual disability, autism spectrum disorder, psychosis, bipolar disorder, or neurologic conditions (e.g., epilepsy), per caregiver-report.
* Exclusionary sleep disorders. We will exclude adolescents with symptoms of obstructive sleep apnea or periodic limb movement disorder based on published cutoffs on a validated questionnaire.
* High caffeine intake. To promote adherence to directives not to consume caffeine the day of office visits without withdrawal effects, adolescents with daily intake of \>1 coffee or "energy drink" or \>2 caffeinated sodas per day based on caregiver- and adolescent-report will be excluded.
* Unwillingness or inability to take part in study procedures (e.g., visits, prescribed sleep conditions).
* Medication use or unwillingness to discontinue melatonin and/or stimulant medications during the 3-week study protocol.
* Refusal to refrain from automobile driving during the sleep restriction condition.
* "Intermediate" Chronotypes (neither morning larks nor night owls) based on habitual sleep timing on nights when adolescent has no morning obligations such as school or work. BEHAVIORAL: Aligned sleep extension, BEHAVIORAL: Misaligned sleep extension
ADHD
Evaluating Additive Effects of Including Canines in Regulating Together
Carrie Fassler - carrie.fassler@cchmc.org
ALL
8 years to 15 years old
NA
NCT05803343
Inclusion Criteria:
* Concern of emotion dysregulation (ED) as measured by a score of 6 or greater on the Emotion Dysregulation Inventory-Reactivity (EDI-R)
* Diagnosis of autism spectrum disorder (ASD)
* Diagnosis confirmed by an experienced ASD clinician and further supported by scoring in the range for ASD on the Autism Diagnostic Observation Schedule (ADOS-2)
* A Full Scale Intelligence Quotient score of 65 or greater on the Weschler Abbreviated Scale Intelligence (WASI-II)
* English is the primary language
* Family willing to keep prescribed medication stable over the course of the study period
Exclusion Criteria:
* Participant has a phobia toward or is allergic to canines
* Participant has a history of aggression toward animals
* Participant has had any physical aggression toward other children outside the home in the past 2 weeks that resulted in injury
* Presence of comorbid major neuropsychiatric illness warranting other treatment approaches as determined by the study clinician(s) including substance use disorders, psychotic disorders/schizophrenia, and bipolar disorder, among others
* Presence of any major sensory impairment that would limit participating in the material including blindness or uncorrected hearing loss
* A legal guardian is not available to provide informed consent BEHAVIORAL: Regulating Together-Canine, BEHAVIORAL: Regulating Together-Standard
Autism Spectrum Disorder, Emotion Regulation
ADHD PreSMA Response Inhibition Therapy
Karlee Migneault - karlee.migneault@cchmc.org
ALL
12 years to 17 years old
NA
NCT06325813
Inclusion Criteria:
• ADHD diagnosis
• Ages 12-17 years
• Stimulant use is allowed but must be discontinued 24 hours prior to and during days of TMS visit
Exclusion Criteria:
• Medical conditions contraindicated or associated with altered TMS risk profile, including history of intracranial pathology, epilepsy or seizure disorders, traumatic brain injury, brain tumor, stroke, intellectual disability, cerebral palsy, neurodegenerative conditions, hearing impairment, metallic objects in the head or any other serious medical condition
• Presence of any implanted medical devices (e.g., ports, shunts, stimulators, cochlear implants)
• For biological females who are post-menarche, current pregnancy based on urine pregnancy test.
• Baseline problem of hearing impairment or chronic tinnitus
• Any clinically significant finding on brain MRI
• History of DSM-5 conduct disorder, major depressive disorder, bipolar disorder, obsessive compulsive disorder, anxiety disorder, psychotic disorder
• Non-stimulant medication(s) for ADHD (e.g., alpha2 adrenergic agonist, atomoxetine, tricyclics)
• Neuroleptic/antipsychotic medication(s)
• Inability to undergo MRI
• Active suicidality, history of suicidality, or high risk for suicide as assessed by a study physician
• Substance abuse or dependence within the past year, based on 1) separate screening process of asking parent/guardian and participant, and 2) positive urine drug screen. Exception will be made for positive urine drug screen due to prescribed ADHD medication
DEVICE: Active repetitive TMS, DEVICE: Sham repetitive TMS
Attention Deficit Hyperactivity Disorder
ADHD, Transcranial Magnetic Stimulation
Epilepsy Journey-An Executive Functioning Intervention for Teens With Epilepsy
Stacy Buschhaus - stacy.buschhaus@cchmc.org
ALL
13 years to 17 years old
NA
NCT06608966
Inclusion Criteria:
• Age between 13-17 years at the time of enrollment
• Child lives at home with primary caregiver and is enrolled in school (excluding summer breaks).
• Confirmed diagnosis of epilepsy with seizures that are categorized as either generalized or focal in onset. Epilepsy is defined as: 1) At least two unprovoked seizures occurring more than 24-hours apart; or 2) One unprovoked seizure and a probability of further seizures similar to the general recurrence risk after two unprovoked seizures.
• Primary language of English
• Screening Inclusion: On the parent-reported Behavior Rating Inventory of Executive Function-2nd edition (BRIEF-2), have executive functioning deficits defined as at least 2 subclinical (60\
• Participant willing to sign an Institutional Review Board approved assent
Exclusion Criteria:
• Parent or clinician-reported history in the adolescent of:
• developmental delay (e.g., autism spectrum disorder, pervasive development disorder, history of services for developmental delay or intellectual impairment in the past 5 years, known IQ\<70)
• severe mental illness (e.g., schizophrenia, bipolar disorder, eating disorder within the past 12 months, depression with active suicidal ideation or suicidal ideation/intent in the past 3 months)
• prior (3-months) or current history of trauma and/or stressor-related disorders (e.g. PTSD)
• recent or current significant medical disease (i.e., cardiovascular, hepatic, renal, gynecologic, musculoskeletal, metabolic or endocrine)
• brain injury or brain tumor; and/or
• epilepsy surgery
• any other medical and/or psychological condition that takes treatment precedence over the study intervention
• Clinician-reported diagnosis in the adolescent of
• epilepsy whose seizures are categorized only as either unknown onset or unclassified onset (defined as insufficient information to determine onset)
• epilepsy currently being treated at the time of enrollment by 3 or more antiseizure medications (ASMs) (excluding rescue medication use)
• epilepsy with a history of failure to achieve seizure freedom despite adequate use of 4 different anti-seizure medications
• a confirmed or suspected epileptic encephalopathy (e.g., electrical status epilepticus in sleep, Landau Kleffner syndrome, West syndrome)
• a confirmed or suspected progressive and degenerative disorder (e.g., mitochondrial disorders, metabolic disorders, autoimmune disorders)
• one or more episodes of status epilepticus within the 24 weeks prior to enrollment; and/or
• treatable causes of seizures, for example identified etiologies including metabolic, neoplastic, or active infectious origin.
• non-epileptic event/seizures
• Adolescents currently on the ketogenic diet
• Participation in a trial of an investigational drug or device within 30 days prior to screening
BEHAVIORAL: Epilepsy Journey web-based modules, BEHAVIORAL: Telehealth with a therapist
Epilepsy in Children, Executive Dysfunction
adolescents, executive functioning, seizures, epilepsy, behavioral trial, web-based intervention
AWARE: Management of ADHD in Autism Spectrum Disorder
Courtney Herberger - Courtney.Herberger@cchmc.org
ALL
4 years to 17 years old
PHASE4
NCT05916339
Inclusion Criteria:
• Participant and/or legal caregiver must be willing and able to give informed consent/assent for participation in this study.
• Participant and/or legal caregiver must be willing and able (in the Investigator's opinion) to comply with all study requirements.
• Participant must be between 4 and 17 years of age (inclusive) at time of enrollment.
• Participant must have a confirmed diagnosis of ASD based on supportive evidence (e.g. referring physician's report, medical records, such as ADOS or CARS, etc.).
• Participant must have the ability to consistently take medication (via pill, liquid or mixed with food/liquid).
• Participant must have a confirmed diagnosis of ADHD (based upon DSM-5 criteria and supportive evidence).
• Participant must have a consistent reporter (e.g., parent) who spends regular time with the child.
• Participant can be on other psychotropic medications (selective serotonin reuptake inhibitor (SSRI), atypical antipsychotic, anticonvulsant) if dose has been stable for \> 4 weeks prior to consent with no plans for a dose change during the study.
• It has been at least 7 days since the participant last took an ADHD medication and the presiding clinician believes this to be a sufficient amount of time.
• Caregiver must be sufficiently fluent in English or Spanish to be able to complete questionnaires relevant to this study.
Exclusion Criteria:
• Participant has taken ADHD medication within the past 7 days.
• Participant is not stable on other medications (\< 4 weeks).
• Any other risk factor that might prevent patient from safely taking the study medications. * There are no inclusion/exclusion criteria based upon participant IQ. We will include individuals across the entire range of cognition, just as practitioners are asked to treat ADHD in children with ASD across the entire IQ range.
DRUG: Randomization to either Amphetamine (AMP) class of stimulant medication or Methylphenidate (MPH) class of stimulant medication, DRUG: Randomization to either Alpha 2 agonist class of medication or alternate class of stimulant.
ADHD, Autism Spectrum Disorder
ADHD, Autism, ASD
Tracking Early Emergence of Sound Perception Impairments in FXS With Multimodal fNIRS/EEG-Preschool Age
Elizabeth Smith - elizabeth.smith3@cchmc.org
ALL
24 months to 4 years old
NA
NCT05957549
Inclusion Criteria:
* Diagnoses of Fragile X Syndrome, Typical Development, or History of Premature Birth
* able to sit independently
* English is spoken at home
Exclusion Criteria:
* For all participants: no seizures in the past 6 months
* For typical development group and Fragile X group: not born prior to 32 weeks gestation OTHER: Speech discrimination
Fragile X Syndrome
Neuroimaging Reveals Treatment-related Changes in DLD
Kristi Barnett - Kristi.Barnett@cchmc.org
ALL
48 months to 71 months old
NA
NCT05268341
Inclusion Criteria:
* ages 48-71 months
* average nonverbal intelligence quotient (IQ)
* enrolled in participating center
* typically developing (receptive and expressive language, social, articulation, other)
* DLD for expressive grammar
* typical oral motor function
* typical social/pragmatics skills
* average hearing thresholds
* monolingual and native Standard English speakers
* does not have any uncorrected vision challenges
Exclusion Criteria:
* receiving co-occurring speech-language or other intervention for communication
* not MRI safe
* special education placement of child based on ability or behavior BEHAVIORAL: My Sentence Builder
Developmental Language Disorder