Clinical trials: Early Intervention
Child Development
School-Based Mental Health Effectiveness Study
This study involves efforts to advance the science of prevention in early childhood mental health in low-resource communities. Investigators will assess the effectiveness, practical implementation strategies, and underlying…
- Trial name
- NCT04383327
- Testing
- ParentCorps-Professional Development (PD), T-Wellness
- Where
- 2 sites in Uganda
- Volunteers
- 2,444 people, healthy volunteers welcome
- Sponsor
- NYU Langone Health
Pediatric Obesity, Risk Reduction Behavior
FirstStep2Health Intervention
This project will determine the preliminary efficacy of an innovative intergenerational intervention among Head Start preschoolers, aged 3-5 years, and their caregivers.
- Conditions
- Pediatric Obesity, Risk Reduction Behavior, Early Intervention, Intergenerational Relations
- Trial name
- NCT04164277
- Testing
- Caregiver Component., Caregiver-Preschooler Learning., Center-based Preschooler Component.
- Where
- United States
- Volunteers
- 95 people, healthy volunteers welcome
- Sponsor
- Michigan State University
Autism Spectrum Disorder
Tailoring Treatment Targets for Early Autism Intervention in Africa
Naturalistic Developmental Behavioral Interventions (NDBIs), an evidence-based early autism spectrum disorder (ASD) intervention approach, target key behaviors that help language development.
- Trial name
- NCT04068688
- Testing
- Early Start Denver Model (ESDM), Telehealth coaching
- Where
- South Africa
- Volunteers
- 73 people, healthy volunteers welcome
- Sponsor
- Duke University
Psychological Distress
Ensemble Programme an Early Intervention for Informal Caregivers of Psychiatric Patients
This study focuses on the difficulties of maintaining optimal psychological health and quality of life for caregivers in adult psychiatry while they play an important role in helping patients with severe psychiatric disorders.
- Trial name
- Ensemble (NCT04020497)
- Testing
- Ensemble programme, SAU
- Where
- Switzerland
- Volunteers
- 160 people, healthy volunteers welcome
- Sponsor
- Institut et Haute Ecole de la Santé la Source
Aggression
An Evaluation of an Integrated Approach to Prevention and Early Intervention in the Elementary School Years
In this study, the investigators propose to examine whether the combination of a universal, elementary school-based preventive intervention with an indicated preventive and treatment intervention would yield greater impact on…
- Trial name
- P2P+IY (NCT03132805)
- Testing
- PATHS to PAX, PATHS to PAX and the Incredible Years
- Where
- United States
- Volunteers
- 5,233 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
Child Behavior
Trial of KEEP-P, a Preventive Intervention for Foster Preschoolers (KEEP-P)
Randomized Trial of KEEP-P, a Preventive Intervention for Foster Preschoolers (KEEP-P). The goal of the proposed study is to conduct a randomized clinical trial of a new, low-cost, manualized, group-based intervention for…
- Trial name
- KEEP-P (NCT03106636)
- Testing
- KEEP-P, KEEP-P+
- Where
- United States
- Volunteers
- 442 people, healthy volunteers welcome
- Sponsor
- University of Oregon
Breast Cancer
One-stage Breast Reconstruction Using Dermal Matrix/Implant Versus Two-stage Expander/Implant Procedure
Currently the two-stage tissue expander/implant (TE/I) technique is the standard breast reconstructive option for breast cancer patients selected for immediate, skin-sparing mastectomy.
- Trial name
- AllodermRCT (NCT00956384)
- Testing
- One-stage dermal matrix/implant procedure, Two-stage tissue expander/implant procedure
- Where
- 4 sites in Canada
- Volunteers
- 198 people, healthy volunteers welcome
- Sponsor
- University Health Network, Toronto
Cardiovascular Diseases, Infant ALL
Early Intervention to Promote Cardiovascular Health of Mothers and Children (ENRICH)
This pilot study aims to examine the feasibility and acceptability of adding a cardiovascular health module to the existing Nurse Family Partnership (NFP) home visitation program delivered by trained nurses in the Northern…
- Conditions
- Cardiovascular Diseases, Infant ALL, Maternal Behavior, Childhood Obesity
- Trial name
- ENRICH (NCT05824741)
- Testing
- Infant Cardiovascular Health (CVH) Promotion
- Where
- 2 sites in United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Penn State University
Behavior Problems, Child
Early Parenting Intervention Comparison
The purpose of this study is to compare the effectiveness of two parenting programs in a mental health clinic serving young children with behavior problems.
- Trial name
- EPIC (NCT01517867)
- Testing
- Chicago Parent Program, Parent-Child Interaction Therapy
- Where
- United States
- Volunteers
- 161 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
Mild Cognitive Impairment
Early Intervention in Mild Cognitive Impairment (MCI) With Curcumin + Bioperine
This is an additional study to the primary Mild Cognitive Impairment (MCI) study (LSU#H04-049; NCT00243451)that is underway of PET detection of Mild Cognitive Impairment.
- Trial name
- NCT00595582
- Testing
- curcumin + bioperine
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Louisiana State University Health Sciences Center Shreveport
Child Development
Early Literacy Promotion Intervention
This study is testing the effects of early literacy promotion compared to standard literacy promotion at The Children's Hospital of Philadelphia.
- Trial name
- ELPI (NCT02713659)
- Testing
- Early Literacy Promotion, Standard Literacy Promotion
- Where
- United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Children's Hospital of Philadelphia
Cardiovascular Risk Factor
Random Assignment of Intervention Messages for Developing Personalized Decision Rules to Promote Physical Activity
Our goal is to develop personalized decision rules for selecting the frequency, timing, and content of messages to promote physical activity.
- Trial name
- RandomAIM (NCT03907683)
- Testing
- Short Message with Text and Optional Image
- Where
- United States
- Volunteers
- 82 people, healthy volunteers welcome
- Sponsor
- Penn State University
Premature Birth, Feeding and Eating Disorders of Childhood
Evaluation of an Interdisciplinary Decision Guide for Infant Feeding Assessment
Preterm infants are at risk for feeding problems which can persist through early childhood. These feeding problems may include oral motor, sensory, digestive, nutritional, respiratory, and/or behavioral components.
- Trial name
- NCT04850794
- Testing
- Decision Support Tool
- Where
- United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Autism Spectrum Disorder, Neurodevelopmental Disorders
Evaluation of a Novel Intervention for Infants At Risk for Neurodevelopmental Disorders
This study entails a "proof of concept" evaluation of a novel intervention, Parents and Infants Engaged (PIE), for prodromal infants at-risk for neurodevelopmental disorders (NDs).
- Trial name
- PIE (NCT03388294)
- Testing
- Parents and Infants Engaged
- Where
- United States
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Developmental Disability, Early Intervention (Education)
Participation and Environment Measure-Plus (PEM-Plus) Care Planning Intervention
The goal of the proposed research is to achieve a major advance in promoting effective and efficient delivery of pediatric rehabilitation services for young children with developmental disabilities and delays.
- Trial name
- PEM-Plus (NCT03820011)
- Testing
- PEM+
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Mary A Khetani
Hallux Valgus, Bunion
Early Weight-Bearing After the Lapiplasty Mini-Incision Procedure (Mini3D)
Prospective, multicenter, unblinded study to evaluate outcomes of the Lapiplasty® Procedure using the Lapiplasty® Mini-Incision™ System for patients in need of hallux valgus surgery.
- Trial name
- Mini3D (NCT05082012)
- Testing
- Treatment of Hallux Valgus
- Where
- 10 sites in United States
- Volunteers
- 123 people, healthy volunteers welcome
- Sponsor
- Treace Medical Concepts, Inc.
Hearing Loss, Bilateral
Early Communication Intervention for Toddlers With Hearing Loss
Improving spoken language outcomes for children with hearing loss has important public health implications. This is a randomized clinical trial of 96 children with hearing loss that examines the effects of a parent-implemented…
- Trial name
- NCT03803943
- Testing
- Parent-Implemented Communication Intervention (PICT), No Intervention - Business-as-usual control
- Where
- United States
- Volunteers
- 210 people, healthy volunteers welcome
- Sponsor
- Northwestern University
Cardiovascular Diseases, Pregnancy Related
Early Intervention to Promote Cardiovascular Health of Mothers and Children (ENRICH) During Pregnancy
This pilot study aims to examine the feasibility and acceptability of adding a cardiovascular health module to the existing Nurse Family Partnership (NFP) home visitation program delivered by trained nurses in the Northern…
- Conditions
- Cardiovascular Diseases, Pregnancy Related, Sedentary Behavior
- Trial name
- ENRICH (NCT05822531)
- Testing
- Maternal CVH Intervention
- Where
- 2 sites in United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Penn State University
Preterm Infant, Full-term Infant
A Novel Parent Education Program for Early Intervention
One in ten infants born in the USA is born preterm before 37 weeks of gestation and 50% of those will have motor and cognitive delays requiring intervention at school age.
- Trial name
- NCT04266717
- Testing
- Baby Play Intervention, Milestone Education
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- University of Delaware
Postpartum Depression, Small for Gestational Age at Delivery
Happy Mother-Healthy Baby: An Anxiety-focused Early Prenatal Intervention
In the proposed study the investigators will develop an early prenatal preventive intervention targeting anxiety and conduct a randomized controlled trial in Pakistan to test its efficacy in reducing generalized anxiety disorder…
- Conditions
- Postpartum Depression, Small for Gestational Age at Delivery, Preterm Birth, Anxiety
- Trial name
- HMHB (NCT03880032)
- Testing
- Cognitive Behavioral Therapy Intervention for Anxiety
- Where
- Pakistan
- Volunteers
- 1,200 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins Bloomberg School of Public Health