Telehealth Intervention for Infant Emotional Regulation

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Davis

Disqualifiers: Preterm birth, Genetic disorders, TBI, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 15

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. ^{1 2 3 4 5}

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. ^{2 3 6 7 8}

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

Infants must have at least 1 concern about the child's behavior/development expressed by the caregiver

Caregivers must be identified as the infants' primary caregivers

Caregivers must have access to wired or wireless network technology to access the internet in their homes

Exclusion Criteria

My infant has a genetic disorder like fragile X or Tuberous Sclerosis.

My infant has had a traumatic brain injury.

My baby was born before reaching 33 weeks of pregnancy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Baseline periods with varying introduction of treatment elements

3-7 sessions

3-7 sessions (virtual)

Intense Intervention

Caregiver-implemented supportive intervention with new techniques introduced weekly

4-6 weeks

8 sessions (virtual)

Booster Sessions

Weekly booster sessions to reinforce intervention techniques

4 weeks

4 sessions (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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?

Group I: Telehealth Intervention Experimental Treatment 1 Intervention

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).

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

Published Research Related to This Trial

In a study involving 40 racially and ethnically diverse children aged 3-5 with disruptive behavior disorders, Internet-delivered parent-child interaction therapy (I-PCIT) showed a higher treatment response rate (70%) compared to standard clinic-based PCIT (55%) after treatment.

I-PCIT not only resulted in significant improvements in children's symptoms and reduced parental burden but also had fewer perceived barriers to treatment, indicating it may be a more accessible option for families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remotely delivering real-time parent training to the home: An initial randomized trial of Internet-delivered parent-child interaction therapy (I-PCIT). Comer, JS., Furr, JM., Miguel, EM., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05903053

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- ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6059379/

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 ...

3. withpower.com withpower.com/trial/phase-infant-behavior-5-2023-daac5

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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2880630/

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.

5. sciencedirect.com sciencedirect.com/science/article/pii/S0149763425003549

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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4006432/

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 ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2773233925000324

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?

8. jamanetwork.com jamanetwork.com/journals/jamapediatrics/fullarticle/2677898

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 ...