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

8 Participants Needed

Trial Summary

What is the purpose of this trial?

This project will build on the investigators' work focused on early identification of ADHD, expanding to the development of a feasibility/pilot intervention involving early intervention for such infants. The investigators will evaluate the effectiveness of a telehealth-delivered, caregiver-implemented supportive intervention for infants/toddlers show early self-regulation difficulties.

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 data supports the effectiveness of the treatment Early Self-Regulation 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 difficulties. Additionally, interventions that support emotion regulation early in life, especially for infants with higher emotional reactivity, have shown positive effects on emotion regulation strategies. ^{1 2 3 4 5}

Is the Telehealth Intervention for Infant Emotional Regulation safe for humans?

The research on emotional regulation interventions, including parent training and mindfulness, suggests they are generally safe and can improve emotional regulation in children. However, more research is needed to confirm these findings due to small sample sizes in studies. ^{2 6 7 8 9}

How does the Early Self-Regulation Intervention treatment differ from other treatments for infant emotional regulation?

The Early Self-Regulation Intervention is unique because it is delivered through telehealth, allowing for remote support to families, which is particularly beneficial during situations like the COVID-19 pandemic when in-person visits are challenging. This approach ensures continued access to care and maintains treatment fidelity, making it a novel option compared to traditional in-person interventions. ^{10 11 12 13 14}

Research Team

Meghan Miller, Ph.D.

Principal Investigator

University of California, Davis

Eligibility Criteria

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

My infant has a parent or sibling with ADHD.

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

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Caregiver-mediated interventions to support self-regulation among infants and young children (0-5 years): a protocol for a realist review. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Maternal self-regulation, relationship adjustment, and home chaos: contributions to infant negative emotionality. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Supporting Infant Emotion Regulation Through Attachment-Based Intervention: a Randomized Controlled Trial. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Sleep moderates the association between routines and emotion regulation for toddlers in poverty. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

The Effect of Excessive Crying on the Development of Emotion Regulation. [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Emotional Self-Regulation in Everyday Life: A Systematic Review. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Maternal History of Adverse Experiences and Posttraumatic Stress Disorder Symptoms Impact Toddlers' Early Socioemotional Wellbeing: The Benefits of Infant Mental Health-Home Visiting. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Infant and toddler crying, sleeping and feeding problems and trajectories of dysregulated behavior across childhood. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Emotional Regulation Interventions on Developmental Course for Preterm Children: A Systematic Review of Randomized Control Trials. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Introduction of Special Section of Infant Mental Health Journal: Meeting the needs of vulnerable infants and families during COVID-19: Moving to a telehealth approach for home visiting implementation and research. [2022]

11. United States 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). [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Transitioning to telehealth due to COVID-19: Maintaining model fidelity in a home visiting program for parents of vulnerable infants. [2022]

13. Switzerland pubmed.ncbi.nlm.nih.gov

Pediatricians, Well-Baby Visits, and Video Intervention Therapy: Feasibility of a Video-Feedback Infant Mental Health Support Intervention in a Pediatric Primary Health Care Setting. [2020]

14. England pubmed.ncbi.nlm.nih.gov

A nonrandomized trial of a behavioral parent training intervention for parents with children with challenging behaviors: In-person versus internet-HOT DOCS. [2021]