Helping Toddlers and Parents Together

Not Applicable

Recruiting

• Conditions: ADHD; Parenting
• Interventions: Behavioral: Behavioral Parent Training

• Registration Number: NCT04864808
• Lead Sponsor: University of Maryland, College Park

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2021-04-22
• Study First Submitted: 2021-04-23
• Study First Submitted QC: 2021-04-27
• Study First Posted: 2021-04-29
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-09
• Last Update Posted: 2023-05-11
• Primary Completion: 2023-10
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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:

1. Sign informed consent online
2. Be between 21-55 years old (inclusive) and be English or Spanish-speaking
3. Meet full DSM-5 criteria for ADHD, any subtype as determined by the SCID-5
4. Have current CGI-S-ADHD rating ≥ 4 and < 7
5. Commit to the entire study
6. 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:

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Behavioral Parenting Training	Behavioral Parent Training	-

Primary Outcome Measures

Name	Time	Method
Acceptability	up to 12 weeks	Client Satisfaction Questionnaire (CSQ-8)- higher scores indicate more satisfaction

Trial Locations

Locations (1)

Children's National Medical Center; 🇺🇸 Washington, District of Columbia, United States