Mental Health
Conditions
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.
Interventions
BEHAVIORALBehavioral 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 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.
Sponsors
Northwestern University
National Institute of Mental Health (NIMH)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Psychiatric Symptoms and Diagnosis | 12 month | Parent interview to assess psychiatric disorders in preschool age children also known as the PAPA. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Early Regulation and Context Assessment (ERICA) | Baseline, 6- and 12 month | ERICA stands for early regulation and context assessment which is a direct assessment of child regulation skills. |
| Multidimensional Assessments Profile Scale (Temper Loss) (MAPS-TL) | 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. |
| Strengths and Difficulties Questionnaire (SDQ) | 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. |
| Early Childhood-Patient-Reported Outcomes Measurement Information System- Effortful Control (EC-PROMIS-EF) | 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). |
| Parenting Young Children (PARYC) | 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. |
| Minnesota Executive Function Scale (MEFS) | 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. |
| Multidimensional assessment profiles- Early Assessment Screening for Irritability (MAPS-EASI) Impairment Plus | 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. |
| Child and Parent Relationship Scale (CPRS) | 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. |
Countries
United States
Contacts
CONTACTScientific Project Director Peds-BRITE
Outcome results
None listed