Nemours Children's Health
Wilmington, Delaware, 19803, United States
Location status: Recruiting
NCT Number: NCT07091240
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Wilmington, Delaware, 19803, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 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.
Time frame: 12 month
Parent interview to assess psychiatric disorders in preschool age children also known as the PAPA.
Time frame: Baseline, 6- and 12 month
ERICA stands for early regulation and context assessment which is a direct assessment of child regulation skills.
Time frame: 12-month
This is a survey of child temper loss and irritability. Parents report on children's behavior on a scale of children's irritable behaviors on a scale from zero (never) to five (many times each day). They also report on the impact of child irritability on a scale from zero (no problems) to three (severe problems). Scores are summed and higher scores indicate more irritability behaviors.
Time frame: Baseline, 6- and 12-month
The SDQ is a brief child behavior screening questionnaire. Parents report on children's strengths and difficulties on a three point scale (not true, somewhat true and certainly true). They also report on the impact of these strengths and difficulties on a four point scale which varies (e.g., no/yes with minor difficulties, definite difficulties/severe difficulties; not at all, only a little, a medium amount, a great deal). The total difficulties score is on a scale of 0 to 40 with higher scores indicating more difficulties. Then the internalizing and externalizing scores range from zero to twenty with higher scores indicating more emotional and peer difficulties. The impact score ranges from zero to 10 with higher scores indicating greater impact on daily life.
Time frame: 6- and 12-month
Parent reported measure of children's effortful control. There are six parent report items on child's frustration tolerance and flexibility each item is on a five point scale from never (meaning no frustration tolerance and flexibility) to always (e.g., always flexible).
Time frame: Baseline, 6-, 12 month
Parenting Young Children (PARYC): Proactive Parenting: The PARYC (Proactive Parenting Subscale) includes 7 questions related to parenting behaviors that are supportive of children's early mental health and development. The survey takes less than 5 minutes to complete.
Time frame: Baseline, 6- and 12-months
Direct assessment of executive functioning that is completed by children on an internet browser i.e., children complete a card sorting task.
Time frame: Baseline 6- and 12 months
The MAPS-EASI is a shortened version MAPS-TL designed for clinical screening. Parents report on children's irritable behaviors on a scale of zero (never) to five (many times each day). They also report on the impact of irritability on a scale from zero (no problems) to three (severe problems). Scores are summed and higher scores indicate more irritability behaviors. There is a maximum score of 15 for irritable behaviors and there is a maximum score of 6 on impact. The impairment items ask about how irritability affects families' lives and the plus items ask about how they affect children in varying contexts.
Time frame: Baseline, 6-, and 12-month assessments
Child and Parent Relationship Scale (CPRS): The CPRS includes 7 questions about the closeness of the parent-child relationship. It takes less than 5 minutes to complete.
Contact information is provided by the study sponsor or research team.
Northwestern University
Other
Innovative Risk Calculator and Telehealth Delivered Parenting Program for Mental Health Promotion in Pediatric Primary Care: A Hybrid Type 3 Effectiveness-Implementation Study
Acronym: Peds-BRITE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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