Helping Toddlers and Parents Together

University of Maryland

Status

Withdrawn

Conditions

Parenting

ADHD

Treatments

Behavioral: Behavioral Parent Training

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT04864808

R01MH118320-02S1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

Using stakeholder feedback (i.e., behavioral health providers & caregivers), the goal of this study is to develop a behavioral parenting program that focuses on both parent mental health and parenting for parents of toddlers (12-35 months old). Using a deployment focused intervention model, this study will : (1) develop an early parenting intervention for parents of at-risk toddlers which integrates a focus on parent mental health with evidence-based behavioral parenting strategies, and (2) examine context-specific factors related to the intervention, including feasibility and acceptability to design a more practice-ready intervention.

Full description

Very early identification of children and families at risk of developing psychopathology can lead to early prevention/intervention to address challenging behaviors before they become more severe, likely reducing the length and cost of interventions. Using the information provided by the stakeholder group, the current study will implement in an open trial the early parenting intervention for ADHD parents of at-risk toddlers (n = 10 families) via telehealth by primary care co-located psychologists. Investigators will examine implementation factors including fidelity, feasibility (utility, adherence) and acceptability (facilitators, barriers) of the early parenting intervention. Quantitative data (adherence checklists, symptom measures, observational parenting measures) will be used to assess the extent to which primary care providers and office staff adhere to the intervention manual, as well as changes in toddler and parent behavior resulting from the intervention. Qualitative data (interviews/ focus groups) with stakeholders (behavioral health providers and caregivers of toddlers) will inform a refined intervention model and assess perceptions of utility, fit, and satisfaction of the intervention components. This mixed-methods approach will offer the most comprehensive examination of an early parenting intervention model for parents of at-risk toddlers in a pediatric primary care setting.

Sex

All

Ages

12 months to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

To be included in the stakeholder group, participants must work at a CNMC primary center or must be a parent with a toddler.

For inclusion to participate in the pilot intervention, a full-time guardian must, at the time of screening:

Sign informed consent online
Be between 21-55 years old (inclusive) and be English or Spanish-speaking
Meet full DSM-5 criteria for ADHD, any subtype as determined by the SCID-5
Have current CGI-S-ADHD rating ≥ 4 and < 7
Commit to the entire study
Be able to complete all study assessments virtually (i.e., they must have a device that connects to the internet with a camera)

Parents with common comorbid conditions will be included provided that: (a) they do not report active suicidal ideation with intent; and (b) if receiving an antidepressant medication, their medication is well-tolerated and has not changed within 30 days.

For inclusion to participate in the pilot intervention, toddlers must:

be between ages of 12 - 35 months at time of consent
score above the 75th percentile on the BITSEA problem scale

Exclusion criteria

Parents will be excluded on the basis of current bipolar disorder, schizophrenia, psychoses, or other primary psychiatric disorder requiring other immediate treatment.