Innovative Risk Calculator and Telehealth Delivered Parenting Program for Mental Health Promotion in Pediatric Primary Care: A Hybrid Type 3 Effectiveness-Implementation Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Northwestern University
- Enrollment
- 432
- Locations
- 1
- Primary Endpoint
- Psychiatric Symptoms and Diagnosis
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Family Check-up Online (FCU-O)
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.
Intervention: Behavioral Parent Training (Behavioral)
Outcomes
Primary Outcomes
Psychiatric Symptoms and Diagnosis
Time Frame: 12 month
Parent interview to assess psychiatric disorders in preschool age children also known as the PAPA.
Secondary Outcomes
- Early Regulation and Context Assessment (ERICA)(Baseline, 6- and 12 month)
- Multidimensional Assessments Profile Scale (Temper Loss) (MAPS-TL)(12-month)
- Strengths and Difficulties Questionnaire (SDQ)(Baseline, 6- and 12-month)
- Early Childhood-Patient-Reported Outcomes Measurement Information System- Effortful Control (EC-PROMIS-EF)(6- and 12-month)
- Minnesota Executive Function Scale (MEFS)(Baseline, 6- and 12-months)
- Parenting Young Children (PARYC)(Baseline, 6-, 12 month)
- Multidimensional assessment profiles- Early Assessment Screening for Irritability (MAPS-EASI) Impairment Plus(Baseline 6- and 12 months)
- Child and Parent Relationship Scale (CPRS)(Baseline, 6-, and 12-month assessments)
Investigators
Justin D. Smith
Professor
University of Utah