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Telehealth Intervention for Infant Emotional Regulation
N/A
Waitlist Available
Led By Meghan Miller, Ph.D.
Research Sponsored by University of California, Davis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediately following session #8 (end of week 4)
Awards & highlights
Study Summary
This trial will create an intervention to help early identify and help infants/toddlers with self-regulation difficulties using telehealth.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this is a behavioral intervention delivered via telehealth, there are no direct medical side effects like those associated with medications or surgical procedures. However, participants may experience stress or fatigue due to involvement in the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ immediately following session #8 (end of week 4)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately following session #8 (end of week 4)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Caregiver Fidelity of Implementation
Child attention regulation
Child emotion regulation
+4 moreSecondary outcome measures
Infant/Early Childhood Behavior Questionnaire (IBQ/ECBQ) - Effortful control
Parent concerns interview
Trial Design
1Treatment groups
Experimental Treatment
Group I: Telehealth InterventionExperimental Treatment1 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).
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Who is running the clinical trial?
University of California, DavisLead Sponsor
910 Previous Clinical Trials
4,706,983 Total Patients Enrolled
1 Trials studying Infant Development
102 Patients Enrolled for Infant Development
Meghan Miller, Ph.D.Principal InvestigatorUniversity of California, Davis
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My infant has a parent or sibling with ADHD.My infant has a genetic disorder like fragile X or Tuberous Sclerosis.My infant has had a traumatic brain injury.My caregiver speaks English.My child shows early signs of ADHD according to a specific behavior rating.My baby was born before reaching 33 weeks of pregnancy.My infant cannot participate in assessments due to severe sensory or motor issues, or a fragile health condition.My child is between 12 to 18 months old.
Research Study Groups:
This trial has the following groups:- Group 1: Telehealth Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the research project admit participants who are thirty years of age or older?
"As per the stated requirements for this clinical research, participants must be between 12 and 18 months of age."
Answered by AI
How do I gain eligibility for enrollment in this experiment?
"To qualify for this infant development trial, candidates must be within the ages of 12-18 months old. A total of 8 applicants will accepted into the program."
Answered by AI
Is recruitment currently underway for this experiment?
"This particular trial, which was initially posted on June 15th 2023 and last updated on the 5th of June, is not accepting enrollees at this time. Nonetheless, 41 other medical trials are currently recruiting patients."
Answered by AI
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