Pediatricians Building Resilience Through Early Identification for Toddler Well-Being
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Behavioral Parent Training.
- Who it may be relevant to
- Registry conditions: Mental Health. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Innovative Risk Calculator and Telehealth Delivered Parenting Program for Mental Health Promotion in Pediatric Primary Care: A Hybrid Type 3 Effectiveness-Implementation Study
Overview
In this study, caregivers of toddlers with a high likelihood of developing mental health challenges will participate in a parenting program, Family Check-Up® Online (FCU-O), and complete assessments related to their child's behavior and their caregiving practices. FCU-O is a parenting support program that offers tools and guidance to support children's emotional and behavioral development. The program is delivered through a secure website that can be accessed via computer or phone at participating caregivers' convenience. Caregivers will complete the Developmental Early Childhood Instrument for Deciding Effectively about Mental Health (DECIDE) tool, a risk calculator that screens for early signs of future mental health challenges, at their child's 24- or 30-month well-check visit with their pediatrician. Clinicians will use the DECIDE tool risk calculator score to refer caregivers of at-risk children to FCU-O. Caregivers may use FCU-O independently, or they may work with a trained coach who will facilitate their use of the program. Participation is open to caregivers who are referred to FCU-O based on their DECIDE risk calculator score by their child's pediatrician, and is available in English or Spanish. Participants will also complete assessments via survey and direct observation before beginning FCU-O, and 6- and 12-months after their referral to FCU-O.
Interventions
- Behavioral Behavioral Parent Training
Family Check-Up® Online is delivered through a secure website that can be accessed via computer or phone at participating caregivers' convenience. Caregivers will complete the Developmental Early Childhood Instrument for Deciding Effectively about Mental Health (DECIDE) tool, a risk calculator that screens for early signs of future mental health challenges, at their child's 24- or 30-month well-check visit with their pediatrician. Clinicians will use the DECIDE tool risk calculator score to refe
Primary outcome measures
- Psychiatric Symptoms and Diagnosis [Time frame: 12 month]
Secondary outcome measures (8)
- Early Regulation and Context Assessment (ERICA) [Time frame: Baseline, 6- and 12 month]
- Multidimensional Assessments Profile Scale (Temper Loss) (MAPS-TL) [Time frame: 12-month]
- Strengths and Difficulties Questionnaire (SDQ) [Time frame: Baseline, 6- and 12-month]
- Early Childhood-Patient-Reported Outcomes Measurement Information System- Effortful Control (EC-PROMIS-EF) [Time frame: 6- and 12-month]
- Parenting Young Children (PARYC) [Time frame: Baseline, 6-, 12 month]
- Minnesota Executive Function Scale (MEFS) [Time frame: Baseline, 6- and 12-months]
- Multidimensional assessment profiles- Early Assessment Screening for Irritability (MAPS-EASI) Impairment Plus [Time frame: Baseline 6- and 12 months]
- Child and Parent Relationship Scale (CPRS) [Time frame: Baseline, 6-, and 12-month assessments]
Eligibility criteria
Inclusion criteria
- Parents of toddler ages 22 month to 39 months who screen elevate on the Developmental Early Childhood Instrument for Deciding Effectively about Mental Health (DECIDE) tool risk calculator in a participating health center's pediatric practice
Exclusion criteria
- Unable to complete measures and consent process in English or Spanish
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Nemours Children's Health — Wilmington
Identifiers
NCT: NCT07091240 · P50MH122402-PB · P50MH132502