Status:
WITHDRAWN
Helping Toddlers and Parents Together
Lead Sponsor:
University of Maryland, College Park
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Children's National Research Institute
Conditions:
ADHD
Parenting
Eligibility:
All Genders
12-55 years
Phase:
NA
Brief Summary
Using stakeholder feedback (i.e., behavioral health providers \& caregivers), the goal of this study is to develop a behavioral parenting program that focuses on both parent mental health and parentin...
Detailed Description
Very early identification of children and families at risk of developing psychopathology can lead to early prevention/intervention to address challenging behaviors before they become more severe, like...
Eligibility Criteria
Inclusion
- \- To be included in the stakeholder group, participants must work at a CNMC primary center or must be a parent with a toddler.
- For inclusion to participate in the pilot intervention, a full-time guardian must, at the time of screening:
- Sign informed consent online
- Be between 21-55 years old (inclusive) and be English or Spanish-speaking
- Meet full DSM-5 criteria for ADHD, any subtype as determined by the SCID-5
- Have current CGI-S-ADHD rating ≥ 4 and \< 7
- Commit to the entire study
- Be able to complete all study assessments virtually (i.e., they must have a device that connects to the internet with a camera)
- Parents with common comorbid conditions will be included provided that: (a) they do not report active suicidal ideation with intent; and (b) if receiving an antidepressant medication, their medication is well-tolerated and has not changed within 30 days.
- For inclusion to participate in the pilot intervention, toddlers must:
- be between ages of 12 - 35 months at time of consent
- score above the 75th percentile on the BITSEA problem scale
Exclusion
- Parents will be excluded on the basis of current bipolar disorder, schizophrenia, psychoses, or other primary psychiatric disorder requiring other immediate treatment.
Key Trial Info
Start Date :
April 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04864808
Start Date
April 22 2021
End Date
March 1 2025
Last Update
April 15 2025
Active Locations (1)
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1
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010