Pediatrics

Official Title

Determining the Optimal Treatment Intensity for Children with Language Impairment

Purpose

The purpose of the study is to determine the amount of speech-language intervention children need to make improvements.

We hope to identify the appropriate amount of intervention needed as well as the point at which adding more intervention is no longer beneficial.

Participation in this study will last for approximately 10 weeks with one 2 hour session before the book reading intervention, one 2 hour session after the book reading intervention and a 6-month follow up.

Could this study be right for you?

Inclusion Criteria:

• Your child is between the ages of 5 and 6 years 11 months old
• Has received a primary diagnosis of a Language Impairment with vocabulary deficits
• Receives Speech and Language services through their school
• Primarily communicates in English

Age Range

5 and up

Official Title

The Chaperone Study: A multi-center, double-masked, randomized, placebo-controlled, phase III study of the safety and efficacy of atropine 0.1% and 0.01% ophthalmic solutions administered with a microdose dispenser for the reduction of pediatric myopia progression

Purpose

Is your child nearsighted?

Nearsightedness, or myopia, is a condition that results in blurry vision when looking at distant objects.

Myopia happens when the eyeball grows too long or the cornea (the clear front cover of the eye) is too curved.
As a result, light entering the eye is not focused correctly. While glasses and contact lenses can help a person with myopia see clearly, they do not address the underlying stretching of the eye.

Myopia detected in young children tends to increase through the school years . As myopia progresses, it can increase the risk of retinal detachment, cataracts, myopia maculopathy and even blindness. To date, FDA has not approved any drug therapies for reducing myopia progression.

This is why researchers are working to develop new medications and technologies that may help children and teens with this condition. The CHAPERONE Study is a research study testing the safety and effectiveness of microdosed atropine eye solution to see if it slows the progression of myopia in children.

Could this study be right for you?

- Is your child between 3-12 years old?
- Does your child need glasses to see distant objects?
- Is your child able to go to periodic visits at the study clinic to check his/her vision and overall eye health over a 4-year period (11 scheduled visits will be required)?
- Are you available to speak with study staff by phone periodically between your child’s clinic visits to review your child’s experience using study medication?

This study is not for children who have:
- Used atropine or other myopia drug therapies
- Had prior eye surgery
- A systemic disease or condition that can affect their vision

Age Range

3 and up

Official Title

SMALL Talk: Study of Milestones to Advance Language Learning

Purpose

The goal of this study is to identify early risk for developmental language disorder (DLD) among young, low-income children, and to determine how caregiver and child chronic stress and interaction quality interact to disrupt language growth among these children. The long-term objective is to identify pathways through which early family situations and the conditions of poverty disrupt early language paths among low-income children and contribute to heightened rates of DLD.

Could this study be right for you?

Inclusion criteria are: - have a child that is 9 months or younger - child resides in a low-income household, using some sort of government assistance or using the 200% threshold from the Department of Health and Human Services based on annual household income and number of persons in home Exclusion criteria: - Children who are multiple births, preterm (<35 weeks), and have profound or severe disabilities will be excluded, with the latter including congenital blindness, deafness, Down syndrome and other frank neurological deficits.

Official Title

M16-047: A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Upadacitinib in Combination with Topical Corticosteroids on Adolescent and Adult Subjects with Moderate to Severe Atopic Dermatitis

Purpose

The purpose of this study is to compare the effectiveness and safety of Upadacitinib (ABT-494) to placebo (pill without any active substance that looks like upadacitinib) in combination with topical corticosteroids for adolescents (12-17 years of age) and adults (18-75 years of age with moderate to severe atopic dermatitis (AD).

Could this study be right for you?

- Adolescent subjects must weigh more than 40 kg (88 lb) - Subject must be in good general health (other than Atopic Dermatitis) - Subject must have chronic Atopic Dermatitis (AD) with onset of symptoms at least 3 years before first dose of study medication - Subject must have documented history of inadequate response to topical corticosteroids (TCS), topical calcineurin inhibitor (TCI), or systemic treatment for AD within 6 months prior to first dose of study medication - Female subjects must not be pregnant, breastfeeding, or considering becoming pregnant for the duration of the study and for 30 days after last dose of the study drug. - No history of drug or alcohol abuse in the 6 months prior to receiving the first dose of study medication

Age Range

12 and up

Official Title

Relationship Dynamics in Families of Children with ADHD and Their Opposite-Sex Siblings

Purpose

This study is being done to better understand relationship dynamics between children with ADHD, their siblings, and their parents. Our goal is to better understand how differences in family dynamics affect children with ADHD. Participants will be asked to fill out several self-report questionnaires and engage in a family conflict task. During several tasks, participants will have various physiological measures (e.g., heart rate, breathing rate, etc.) taken using electrodes placed on their body. Results of this study will be used to develop other studies and to inform future treatment and prevention programs.

Could this study be right for you?

We are recruiting children between 8 and 10 years old with an opposite sex sibling. In order to participate, families must meet the following criteria:
• Mothers must be willing to participate,
• They must have a child between ages 8 and 10, and
• That child must have a sibling of the opposite sex that is within 2 years of their age

Age Range

6 and up

Official Title

A Double-blind, Placebo- and Active-controlled Evaluation of the Safety and Efficacy of Levomilnacipran ER in Pediatric Patients 7-17 Years With Major Depressive Disorder

Purpose

The purpose of this research study is to evaluate the drug Levomilnacipran extended-release to see how well the drug works, observe the side effects, and how well tolerated it is compared to placebo in pediatric patients with major depressive disorder.

Could this study be right for you?

Your child may be eligible if:
• be between 7 and 17 years of age
• give their assent (a simplified version of this consent form that your child will sign)
• have a diagnosis of Major Depressive Disorder
• meet all of the additional relevant inclusion criteria
• understand the study instructions, and be willing and able to follow these instructions

Exclusion Criteria:
• Your child will not be able to take part in the study if she is pregnant, nursing, or planning a pregnancy
• Your child will not be able to take part in this study if he/she takes any illegal substances

Age Range

7 and up

Official Title

Immune Response in Adolescents

Purpose

Our goal in this study is to learn more about the immune system in adolescence and early adulthood. We are looking to enroll healthy children ages 12-18 years old.

Enrollment in the study will require 1 visit to Nationwide Children’s Hospital involving a blood draw and 2 nasal swabs.
The visit will take approximately 1- 1 ½ hour(s). We ask that the family brings a copy of the child’s immunization record to the visit.

Could this study be right for you?

Children will need to meet the following criteria to be in the study:

Inclusion Criteria:
· Parents/Legal guardian able and willing to sign informed consent and the child is willing to sign assent form for participation. All forms are in English.
· Healthy children, age 12-18 years old

Exclusion Criteria:
· Any chronic or congenital conditions that may potentially affect immune responses
· Cough, congestion, fever, rhinorrhea, rash and any other symptoms indicative of infection within the 2 weeks prior to enrollment sampling
· HIV, AIDS or other immunodeficiencies or any other condition that may affect their immune system
· Use of systemic steroids within 2 weeks prior to enrollment
· Immunization(s) within the last 30 days

Age Range

12 and up

Official Title

CHILDHOOD ATROPINE FOR MYOPIA PROGRESSION (CHAMP): A 3-ARM RANDOMIZED, DOUBLE-MASKED, PLACEBO-CONTROLLED, PHASE 3 STUDY OF ATROPINE SULFATE OPHTHALMIC SOLUTION 0.01% AND 0.02%

Purpose

The purpose of the study is to determine if a daily eye drop will help slow the progression of nearsightedness in children.

Could this study be right for you?

Your child may be eligible for this study if he/she is:
*Ages 3- 17
*Nearsighted

Participants will complete visits for follow-up (every 6 months) and to pick up study eye drops (every 3 months).

Please have your child’s current eye glasses prescription available when you call.

Age Range

3 and up

Official Title

Development of Parent-Child Interactions

Purpose

This study will examine how a child’s hearing loss may affect the dynamics of parent-child interactions. The study will observe how normal-hearing and hearing-impaired child learn novel words during videotaped parent-child interactions.

Individual study visits may last 30-45 minutes, and there may be multiple study visits per year.

Could this study be right for you?

- Families with children 9 months to 6 years of age
- Children who do and do not have hearing loss may be eligible to participate in this study

Official Title

Daily and Weekly Rehabilitation Delivery for Young Children with Cerebral Palsy ("DRIVE")

Purpose

The purpose of this study is to find out how to best distribute physical therapy sessions for your children with significant motor delays.

Participants will receive 40 hours of physical therapy. Participants will be randomly assigned to one of the three treatment groups: intensive, moderate or weekly.

Could this study be right for you?

- Children ages 6 months to 24 months of age
- Has a diagnosis of cerebral palsy or an acquired brain injury prior to age of 24 months.
- Has persistent delays in motor skills
- Ability to participate in outpatient physical therapy and attend visits consistently

The intensive group will receive physical therapy 2 hours per day, 5 days per week for 4 weeks followed by a 16 week break from outpatient physical therapy. The intermediate group will receive physical therapy 2 hours per day, 3 days per week for 6.6 weeks followed by a 13 week break from outpatient physical therapy. The weekly group will receive physical therapy for 2 hours per day, 1 day per week for 20 weeks