Pediatricians Building Resilience Through Early Identification for Toddler Well-Being

Официальное название

Innovative Risk Calculator and Telehealth Delivered Parenting Program for Mental Health Promotion in Pediatric Primary Care: A Hybrid Type 3 Effectiveness-Implementation Study

Обзор

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.

Вмешательства

• Поведенческое 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

Первичные конечные точки

• Psychiatric Symptoms and Diagnosis [Срок оценки: 12 month]

Вторичные конечные точки (8)

• Early Regulation and Context Assessment (ERICA) [Срок оценки: Baseline, 6- and 12 month]
• Multidimensional Assessments Profile Scale (Temper Loss) (MAPS-TL) [Срок оценки: 12-month]
• Strengths and Difficulties Questionnaire (SDQ) [Срок оценки: Baseline, 6- and 12-month]
• Early Childhood-Patient-Reported Outcomes Measurement Information System- Effortful Control (EC-PROMIS-EF) [Срок оценки: 6- and 12-month]
• Parenting Young Children (PARYC) [Срок оценки: Baseline, 6-, 12 month]
• Minnesota Executive Function Scale (MEFS) [Срок оценки: Baseline, 6- and 12-months]
• Multidimensional assessment profiles- Early Assessment Screening for Irritability (MAPS-EASI) Impairment Plus [Срок оценки: Baseline 6- and 12 months]
• Child and Parent Relationship Scale (CPRS) [Срок оценки: Baseline, 6-, and 12-month assessments]

Критерии участия

Критерии включения

• 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

Критерии исключения

• Unable to complete measures and consent process in English or Spanish

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Nemours Children's Health — Wilmington

Идентификаторы

NCT: NCT07091240 · P50MH122402-PB · P50MH132502

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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