Language Development

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No Placebo
Highly Paid
Stay on Current Meds
Pivotal Trials (Near Approval)
Breakthrough Medication
This study is a randomized clinical trial that uses a Sequential Multiple Assignment Randomized Trial (SMART) study design. The study will directly compare the efficacy of an innovative intervention that combines explicit and implicit approaches to a traditional implicit treatment approach to teach true grammatical forms to children with developmental language disorder (DLD). The study will also compare interventions that include sequences of Explicit-added and Implicit-only treatments. Participants will include 5- through 9-year-old children with DLD who present with significant grammatical weaknesses. In Phase 1, 155 participants will be randomized 1:1 to an Explicit-added treatment group or an Implicit-only treatment group. Each participant will complete 32 sessions targeting four unique grammatical forms (8 sessions/form). In Phase 2, "Masters" will be re-randomized to receive no treatment 32 sessions of the same treatment, or 32 sessions of the alternative treatment. "Non-Masters" will be re-randomized to receive 32 additional sessions of the same treatment or 32 sessions of the alternative treatment. Performance will be measured on acquisition, maintenance, and generalization probes obtained immediately,1-, 6-, and 12- months post-intervention. The SMART study design will be used to determine if child factors, including expressive and receptive language abilities, nonverbal IQ, and executive function skills can reliably predict the treatment sequence that optimizes language learning. Study results will help to determine the best sequence approach to ameliorate grammatical weaknesses, one of the core deficits of young children with language impairment.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:5 - 9

200 Participants Needed

The complex and unclear relationship between language and executive function (EF) creates barriers to developing effective interventions for children with developmental language disorder (DLD) whose language difficulties often co-occur with impaired EF. Children and adults with typical language development (TD) facilitate their EF by using self-directed language, or verbal mediation, to guide conscious reflection and override habitual behaviors. Conversely, children with DLD do not use verbal mediation to support EF efficiently or effectively. Promising evidence suggests that language-based training can shape verbal mediation and improve EF task performance in children with TD, which makes it pertinent to determine whether verbal mediation training benefits children with DLD. Specifically, modeling interventions have been shown to promote learning of language forms without taxing the cognitive resources required for learning such as attention or working memory, which are known to be impaired among children with DLD. The long-term goal of the proposed work is to optimize intervention outcomes for children with DLD by elucidating the complex relationship between language and executive functions. The objective of this project is to determine the impact of modeling verbal mediation on shifting task performance in school-aged children with DLD. Shifting, also known as cognitive flexibility, is the ability to alternate between operations or mental sets. It is an important EF because it is the pivot point between multiple goal-directed tasks when language use is critical for guiding action. Children aged 8-10 years will complete three versions of a shifting task over three phases: pre-intervention, intervention, and post-intervention. During the intervention phase, half of the participants with DLD will be exposed to a task model with verbal mediation (training), while the other half will be exposed to a silent task model (control). The investigators will determine the effect of modeling verbal mediation on the subsequent use of verbal mediation (Aim 1) and behavioral and electrophysiological measures of shifting ability (Aim 2). Indirect measures of shifting (i.e., accuracy and reaction time) will be supplemented with an electrophysiological marker of shifting that reflects real-time cue processing. This combination of methods provides insight to changes in processing following intervention that may precede and predict subsequent changes in behaviors. Our central hypothesis is that modeling verbal mediation will facilitate more effective use of verbal mediation and improve shift cue processing in children with DLD. The project will provide a theoretical framework for the role of language in shaping goal-directed behavior and the first examination of electrophysiological change in shifting following a verbal mediation intervention. Results will have a significant impact on clinical practice by advancing knowledge about a promising language-based intervention to support EF and other goal-directed tasks.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:8 - 10

75 Participants Needed

This project aims to optimize a critical but understudied ingredient of language intervention provided to children with developmental language disorder (DLD) - feedback. The project will bridge a gap between previous findings in our lab of inefficient feedback processing in DLD and clinical practice by identifying the conditions under which feedback-based learning can be improved in DLD. The investigators hypothesize that the effectiveness of feedback can be significantly enhanced for children with DLD when it is tailored to their unique learning strengths. The rationale for this project is based on evidence that feedback-based learning can be improved by enhancing the dominance of an intact learning system. The project will achieve its aim by manipulating (1) the timing of the feedback (immediate vs. delayed) and (2) the level of the learner's involvement in error correction dictated by feedback (active vs. passive correction). Aim 1 will determine the effect of manipulating feedback timing on learning in 140 school-age children (8-12 years) with DLD. While immediate feedback is processed by the striatum, which is also implicated in implicit learning, delaying the feedback by a few seconds shifts feedback processing to the mediate temporal lobe (MTL)-based declarative learning system. Evidence that delaying feedback improves learning in DLD would support the hypothesis of the implicit deficit theory that intervention should capitalize on declarative learning mechanisms. The project will test a novel alternative feedback-learning parity hypothesis whereby feedback-based learning is optimized when the timing of the feedback is aligned with the dominant learning system at a given time (i.e., immediate feedback during striatal-based probabilistic learning; delayed feedback during MTL-based declarative learning). Within the same group of children, Aim 2 will compare feedback-based learning in children with DLD when feedback (a) prompts active self-correction or (b) passively exposes learners to error corrections (corrective recast). Children will engage in two nonword-object paired-associate learning tasks. In one task, feedback will promote active self-correction, which is in line with declarative learning. In the other task, feedback will passively expose the learner to corrective feedback in a manner consistent with teaching approaches aiming at reducing awareness of errors. The project will determine whether children with DLD learn better when feedback prompts self-correction or when they are exposed to passive corrections. Electrophysiological measures will indicate whether passive corrections (corrective recast) are processed as negative feedback by children with DLD. For both aims, behavioral indicators of response to feedback will be complemented by electrophysiological measures of feedback processing that can determine the involvement of the striatum and MTL brain systems during the learning process. This work is scientifically and clinically significant because elucidating what manipulations optimize feedback-based learning will enhance our understanding of the impaired learning mechanism in DLD and will provide clinical guidance on what type of feedback to use during an intervention.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:8 - 12

100 Participants Needed

The goal of this clinical trial is to determine how memory and attention affect the ability of children with developmental language disorder (DLD) to learn and use new vocabulary.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:5 - 10

120 Participants Needed

The broad aim of this clinical study is to assess the hypothesis that morphological and phonological deficits are linked by a broader deficit in sequential pattern learning. This hypothesis applies to learning in general, but is especially critical as an avenue for developing earlier assessments and more powerful interventions for children with developmental language disorder (DLD; also known as specific language impairment). Other populations, such as at-risk toddlers, may also benefit from this new approach.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:4 - 8

400 Participants Needed

This broad aim of this clinical study is to assess the hypothesis that morphological and phonological deficits are linked by a broader deficit in sequential pattern learning. This hypothesis applies to learning in general, but is especially critical as an avenue for developing earlier assessments and more powerful interventions for children with developmental language disorder (DLD; AKA specific language impairment). Other populations, such as at-risk toddlers, may also benefit from this new approach.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 30

1260 Participants Needed

This broad aim of this clinical study is to assess the hypothesis that morphological and phonological deficits are linked by a broader deficit in sequential pattern learning. This hypothesis applies to learning in general, but is especially critical as an avenue for developing earlier assessments and more powerful interventions for children with developmental language disorder (DLD; AKA specific language impairment). Other populations, such as at-risk toddlers, may also benefit from this new approach.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:19 - 36

150 Participants Needed

The overall objective of this research is to determine whether parentese delivered in the video format (Aim 1) and in live interaction (Aim 2) facilitates novel word learning in autistic children and to investigate if there are factors that influence the effect of parentese on word learning (Aim 3).
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 59

100 Participants Needed

This trial compares two programs for young children with autism. One program trains parents to help their kids develop social and communication skills, while the other provides parents with information about autism. The study aims to see which program is more effective in improving children's skills and reducing parental stress.
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting
Age:12 - 42

150 Participants Needed

Of the 12 million children in the USA growing up bilingual, about 1 million experience Developmental Language Disorder (DLD), a disorder in language learning and use. Currently there is no guidance for speech language pathologists (SLPs) as to the language of intervention for emergent Spanish-English bilingual children with DLD. This project will examine the relationship between language proficiency and the language of intervention, considering monolingual intervention (Spanish or English) and interleaved Spanish-English intervention with the goal of improving language outcomes and thereby strengthening long-term academic achievement
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:4 - 6

40 Participants Needed

Of the 12 million children in the USA growing up bilingual, about 1 million experience Developmental Language Disorder (DLD), a disorder in language learning and use. Currently there is no guidance for speech language pathologists (SLPs) as to the language of intervention for bilingual children with DLD with differing degrees of proficiency with English or Spanish. This project will examine the relationship between relative language proficiency and the language of intervention, considering monolingual intervention in English and Spanish and bilingual intervention presented by alternating English and Spanish treatment sessions with the goal of improving language outcomes and thereby strengthening long-term academic achievement.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:4 - 6

120 Participants Needed

The objective of the project is to implement the LENA Start Program at the Alief The objective of the project is to implement the LENA Start Program at the Alief Independent School District in Houston, Texas. The purpose of the study is to learn how maternal expectations about language development influence the child's language development. Also, the study will evaluate how much the mothers believe can affect their child's language development. More specifically, the program implementation will serve as a model that other school districts can readily replicate.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:16 - 30

600 Participants Needed

This trial tests two therapies for young children with autism who haven't responded well to usual treatments. The therapies involve parents playing with their children to encourage communication and social skills. One therapy focuses on general improvement, while the other targets specific weaknesses.
No Placebo Group

Trial Details

Trial Status:Recruiting
Age:3 - 5

40 Participants Needed

Difficulties with speech and language are the first and most notable symptoms of primary progressive aphasia (PPA). While there is evidence that demonstrates positive effects of speech-language treatment for individuals with PPA who only speak one language (monolinguals), there is a significant need for investigating the effects of treatment that is optimized for bilingual speakers with PPA. This stage 2 efficacy clinical trial seeks to establish the effects of culturally and linguistically tailored speech-language interventions administered to bilingual individuals with PPA. The overall aim of the intervention component of this study is to establish the relationships between the bilingual experience (e.g., how often each language is used, how "strong" each language is) and treatment response of bilinguals with PPA. Specifically, the investigators will evaluate the benefits of tailored speech-language intervention administered in both languages to bilingual individuals with PPA (60 individuals will be recruited). The investigators will conduct an assessment before treatment, after treatment and at two follow-ups (6 and 12-months post-treatment) in both languages. When possible, a structural scan of the brain (magnetic resonance image) will be collected before treatment in order to identify if brain regions implicated in bilingualism are associated with response to treatment. In addition to the intervention described herein, 30 bilingual individuals with PPA will be recruited to complete behavioral cognitive-linguistic testing and will not receive intervention. Results will provide important knowledge about the neural mechanisms of language re-learning and will address how specific characteristics of bilingualism influence cognitive reserve and linguistic resilience in PPA.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:40+

60 Participants Needed

This is a small-scale treatment study designed to determine which teaching methods result in the best learning. Treatment focuses on helping children with a developmental language disorder learn parts of grammar. Preschool children will receive assessments to determine whether they have a developmental language disorder and what parts of grammar they have not mastered. Children will receive one-on-one behavioral treatment over a six week period. Half of the children will be first taught a grammatical form they sometimes use and then one they rarely use. The other half will start with a grammatical form they rarely use. The study seeks to determine whether starting with something children sometimes use correctly (an easier part of speech) will speed later learning of something that is harder for them. The children's ability to use the grammatical forms taught to them will be assessed throughout the treatment period and approximately six weeks after treatment ends.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:4 - 6

32 Participants Needed

The goal of this clinical trial is to compare two treatment conditions for late talking toddlers. In 8 weeks of word learning treatment, toddlers will be taught words that sound more like the words they already know or sound less like the words they already know. The investigators see which group learns more, to understand if choosing words that let children use the knowledge they already have helps with learning.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 2
Age:2 - 4

32 Participants Needed

The goal of this clinical trial is to compare word learning outcomes in late talking toddlers who are taught different types of words. The main question it aims to answer is if teaching words that come from categories that children already know (e.g., animals) will aid overall word learning. Children will take part in the Vocabulary Acquisition and Usage for Late Talkers (VAULT) word learning treatment and be taught words from more familiar or less familiar categories to see which group learns more words overall.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:2 - 4

32 Participants Needed

The purpose of this study is to compare developmental outcome for young children (12 to 35 months of age) with astigmatism meeting American Academy of Ophthalmology spectacle prescribing guidelines and who are prescribed and provided spectacles for either Full-Time wear (encouraged and reinforced) or Ad Lib wear (wear dependent on child acceptance).
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:12 - 35

88 Participants Needed

Oral language skills are vital for reading comprehension. Some children, however, are at increased risk for reading comprehension difficulties due to underlying oral language deficits. School-based interventions that target children's abilities to understand and produce spoken language have shown positive effects for improving language and reading comprehension of children with typical development and those at-risk for language disorders, so it is likely that they will benefit children with low oral language skills. The purpose of this study is to examine the efficacy of a small-group intervention for improve language skills in first grade students with low oral language skills.
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:6 - 8

22 Participants Needed

Children with Down syndrome (DS) face life-long struggles with verbal communication. Babble and speech sound development is delayed, and speech can be difficult to understand. Words emerge late, at 21 months on average, compared to 12 months for typical peers, and vocabulary and grammar can remain limited throughout adulthood. Because DS is diagnosed at or even before birth, these difficulties are predictable; yet despite this prognostic knowledge, systematic and sustained proactive interventions have not yet been developed: Most children with DS are not assessed and treated for speech and language delays until age 2 to 4 years. This presents an untapped opportunity space to conduct a clinical trial of a proactive intervention in earliest infancy with the goal of building resilience against the anticipated difficulties. The intervention trialed here is a modified version of Babble Boot Camp (BBC), a proactive speech and language intervention originally developed for young infants with classic galactosemia (CG) (NIH 5R01HD098253). CG is a metabolic disease that, similar to DS, is diagnosed at birth and poses risks for severe speech and language delays. BBC is implemented by a speech-language pathologist who, via telehealth, trains parents to incorporate skill-building activities and routines into their daily lives at home. For the present study, 20 children with DS age birth to 12 months will be recruited and randomized into two treatment arms. One group will receive weekly individualized parent sessions and close monitoring of the child's progress. The second group will receive the same content but at a lower intensity and dosage, via monthly parent group meetings. Both groups will receive their intervention for 10 months. Specific aims are to quantify benefits for babble, speech production, and receptive and expressive language and to investigate associations between conversational dynamics in child-adult interactions and the children's speech and language. Outcomes in speech and language skills will show relative feasibility and benefits for each of these treatment modalities and motivate a larger clinical trial, with the ultimate goal of changing the way infants with DS receive support in their speech and language development, from a deficit-based, remedial model to a proactive one.
No Placebo Group

Trial Details

Trial Status:Recruiting
Age:0 - 12

60 Participants Needed

Why Other Patients Applied

"As a healthy volunteer, I like to participate in as many trials as I'm able to. It's a good way to help research and earn money."

IZ
Healthy Volunteer PatientAge: 38

"My orthopedist recommended a half replacement of my right knee. I have had both hips replaced. Currently have arthritis in knee, shoulder, and thumb. I want to avoid surgery, and I'm open-minded about trying a trial before using surgery as a last resort."

HZ
Arthritis PatientAge: 78

"I've been struggling with ADHD and anxiety since I was 9 years old. I'm currently 30. I really don't like how numb the medications make me feel. And especially now, that I've lost my grandma and my aunt 8 days apart, my anxiety has been even worse. So I'm trying to find something new."

FF
ADHD PatientAge: 31

"I have dealt with voice and vocal fold issues related to paralysis for over 12 years. This problem has negatively impacted virtually every facet of my life. I am an otherwise healthy 48 year old married father of 3 living. My youngest daughter is 12 and has never heard my real voice. I am now having breathing issues related to the paralysis as well as trouble swallowing some liquids. In my research I have seen some recent trials focused on helping people like me."

AG
Paralysis PatientAge: 50

"I was diagnosed with stage 4 pancreatic cancer three months ago, metastatic to my liver, and I have been receiving and responding well to chemotherapy. My blood work revealed that my tumor markers have gone from 2600 in the beginning to 173 as of now, even with the delay in treatment, they are not going up. CT Scans reveal they have been shrinking as well. However, chemo is seriously deteriorating my body. I have 4 more treatments to go in this 12 treatment cycle. I am just interested in learning about my other options, if any are available to me."

ID
Pancreatic Cancer PatientAge: 40
This study seeks to determine the effectiveness of speech/language teletherapy to address disparities in speech and language outcomes in children who are deaf or hard-of-hearing (D/HH). The investigators will enroll D/HH children aged 0-27 months. 140 children who are publicly insured will be randomized to receive usual clinical care or to be given access to an 18-month course of speech-language teletherapy program. 70 children who are privately insured will also be enrolled and will receive usual care. Children will undergo, at baseline and every 9 months thereafter to a study endpoint of 18 months, for a total of 3 timepoints, a battery of in-person and parent-report assessments designed to provide a comprehensive measurement of the child's auditory function, speech, verbal- and non-verbal communication, spoken language, and quality of life.
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:0 - 27

211 Participants Needed

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Frequently Asked Questions

How much do Language Development clinical trials pay?

Each trial will compensate patients a different amount, but $50-100 for each visit is a fairly common range for Phase 2–4 trials (Phase 1 trials often pay substantially more). Further, most trials will cover the costs of a travel to-and-from the clinic.

How do Language Development clinical trials work?

After a researcher reviews your profile, they may choose to invite you in to a screening appointment, where they'll determine if you meet 100% of the eligibility requirements. If you do, you'll be sorted into one of the treatment groups, and receive your study drug. For some trials, there is a chance you'll receive a placebo. Across Language Development trials 30% of clinical trials have a placebo. Typically, you'll be required to check-in with the clinic every month or so. The average trial length for Language Development is 12 months.

How do I participate in a study as a "healthy volunteer"?

Not all studies recruit healthy volunteers: usually, Phase 1 studies do. Participating as a healthy volunteer means you will go to a research facility several times over a few days or weeks to receive a dose of either the test treatment or a "placebo," which is a harmless substance that helps researchers compare results. You will have routine tests during these visits, and you'll be compensated for your time and travel, with the number of appointments and details varying by study.

What does the "phase" of a clinical trial mean?

The phase of a trial reveals what stage the drug is in to get approval for a specific condition. Phase 1 trials are the trials to collect safety data in humans. Phase 2 trials are those where the drug has some data showing safety in humans, but where further human data is needed on drug effectiveness. Phase 3 trials are in the final step before approval. The drug already has data showing both safety and effectiveness. As a general rule, Phase 3 trials are more promising than Phase 2, and Phase 2 trials are more promising than phase 1.

Do I need to be insured to participate in a Language Development medical study?

Clinical trials are almost always free to participants, and so do not require insurance. The only exception here are trials focused on cancer, because only a small part of the typical treatment plan is actually experimental. For these cancer trials, participants typically need insurance to cover all the non-experimental components.

What are the newest Language Development clinical trials?

Most recently, we added Grammar Treatment for Language Developmental Disorders, Signing Instruction for Language Development and Deutetrabenazine for Tardive Dyskinesia to the Power online platform.

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