Telehealth Intervention for Infant Emotional Regulation
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a telehealth program designed to help caregivers support infants and toddlers showing early signs of ADHD, a condition affecting attention and self-control. The program focuses on teaching caregivers strategies to improve their child's emotional regulation through online sessions. Called the Early Self-Regulation Intervention, it seeks infants aged 12-18 months who exhibit early ADHD symptoms and have close family members with ADHD. Caregivers must be the child's main caregiver, speak English, and have internet access at home. As an unphased trial, participants contribute to pioneering research that may shape future ADHD interventions.
Will I have to stop taking my current medications?
The trial information does not specify whether participants need to stop taking their current medications.
What prior data suggests that this telehealth intervention is safe for infants?
Research shows that programs like the one in this trial, which help people manage emotions, are generally safe. Studies on parent training and mindfulness have shown good results, often helping infants and toddlers better handle their feelings. Importantly, these programs have not reported major side effects, meaning participants usually do well with them. This suggests that the telehealth approach in this study should be a safe choice for families considering participation.12345
Why are researchers excited about this trial?
Researchers are excited about this telehealth intervention for infant emotional regulation because it offers a unique, accessible approach to helping caregivers manage their infant's emotional development. Unlike traditional in-person therapy sessions, this intervention is delivered remotely, making it more convenient and accessible for families. Additionally, the method focuses on real-time coaching, allowing caregivers to practice new techniques during sessions with immediate feedback, which is not commonly available in standard treatments. This approach could lead to more effective and timely improvements in infant emotional regulation, providing an innovative alternative to existing methods.
What evidence suggests that this telehealth intervention is effective for infant emotional regulation?
Research has shown that early support from caregivers helps babies learn to manage their emotions better, potentially preventing long-term emotional and behavioral issues. For instance, teaching self-control skills has reduced behavior problems in children by over 40%. Studies also suggest that touch can immediately help newborns develop self-control skills. In this trial, the telehealth intervention aims to teach caregivers effective ways to support their babies' emotional development from an early age.23678
Who Is on the Research Team?
Meghan Miller, Ph.D.
Principal Investigator
University of California, Davis
Are You a Good Fit for This Trial?
This trial is for caregivers of infants aged 12-18 months who show early signs of ADHD and have a relative with ADHD. Infants must exhibit certain behaviors indicating potential ADHD, and caregivers need to express concerns about the child's behavior. Participants must speak English and have internet access at home.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline
Baseline periods with varying introduction of treatment elements
Intense Intervention
Caregiver-implemented supportive intervention with new techniques introduced weekly
Booster Sessions
Weekly booster sessions to reinforce intervention techniques
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Early Self-Regulation Intervention
Trial Overview
The study tests a telehealth-delivered intervention aimed at supporting caregivers in managing infants with early self-regulation difficulties that may indicate signs of ADHD. The effectiveness of this caregiver-implemented program will be evaluated remotely.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
A multiple baseline design across subjects will be used with varying introduction of treatment elements. Baseline periods will be 3, 5, and 7 sessions with the baseline period of 3 and 5 sessions repeated twice for subsequent participants. An intense intervention phase will follow the baseline phase in which 45-60 minute treatment sessions will occur twice per week over the course of 4-6 weeks for a total of 8 sessions. Each week during the intense intervention phase, caregiver coaches will introduce a new treatment technique to the caregiver and allow for caregiver practice with immediate feedback. At the conclusion of the intense intervention phase, coaches will provide "booster" sessions with the caregivers once weekly for 1 month (4 sessions total).
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, Davis
Lead Sponsor
Published Research Related to This Trial
Citations
Pilot Study: a Telehealth Intervention for Caregivers of ...
The investigators will evaluate the effectiveness of a telehealth-delivered, caregiver-implemented supportive intervention for infants/toddlers show early self- ...
Effectiveness of Universal Self-regulation–Based Interventions ...
Self-regulation interventions can be effective in children and adolescents with possible benefits in health and social outcomes. This systematic ...
Telehealth Intervention for Infant Emotional Regulation
Research shows that early caregiver-mediated interventions can improve self-regulation in infants, which helps prevent long-term emotional and behavioral ...
Intervention to Strengthen Emotional Self-Regulation in ...
Children receiving the intervention had a 46% mean decrease in disciplinary referrals and a 43% decrease in suspensions during the 4-month intervention period.
Touch facilitates newborns' self-regulation: Systematic ...
Overall, the findings consistently show the benefits of touch in promoting the immediate self-regulation skills of newborns, particularly supporting the use of ...
Infant Self-Regulation and Early Childhood Media Exposure
This study shows that infants and toddlers with self-regulation difficulties (ie, problems with self-soothing, sleep, emotional regulation, and attention) view ...
Social and emotional learning and physical health ...
This conceptual review addresses the question: Can the development of social and emotional competencies contribute to positive long-term health outcomes?
Effectiveness of Universal Self-regulation–Based ...
This systematic review and meta-analysis assesses the effectiveness and outcomes of interventions to improve self-regulation in children and ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.