Helping Toddlers and Parents Together

NCT04864808 | Withdrawn

• 1 other identifier: R01MH118320-02S1
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

ADHD; Parenting

Outcome Measures

Primary Outcomes (1)

• Acceptability

  Client Satisfaction Questionnaire (CSQ-8)- higher scores indicate more satisfaction

  up to 12 weeks

Study Arms (1)

Behavioral Parenting Training

EXPERIMENTAL

Behavioral: Behavioral Parent Training

Interventions

Behavioral Parent Training BEHAVIORAL

Parents will receive sessions of behavioral parent training with components specifically targeted toward parents with ADHD. The number of sessions will be informed based on stakeholder feedback. Treatment will be delivered via telehealth.

Behavioral Parenting Training

Eligibility Criteria

• Age: 12 Months - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \- To be included in the stakeholder group, participants must work at a CNMC primary center or must be a parent with a toddler.
• 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.
• be between ages of 12 - 35 months at time of consent
• score above the 75th percentile on the BITSEA problem scale

You may not qualify if:

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

Sponsors & Collaborators

• University of Maryland, College Park: lead
• National Institute of Mental Health (NIMH): collaborator
• Children's National Research Institute: collaborator

Study Sites (1)

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

Related Publications (2)

• Chronis-Tuscano A, O'Brien KA, Johnston C, Jones HA, Clarke TL, Raggi VL, Rooney ME, Diaz Y, Pian J, Seymour KE. The relation between maternal ADHD symptoms & improvement in child behavior following brief behavioral parent training is mediated by change in negative parenting. J Abnorm Child Psychol. 2011 Oct;39(7):1047-57. doi: 10.1007/s10802-011-9518-2.

  PMID: 21537894 BACKGROUND

• Bagner DM, Coxe S, Hungerford GM, Garcia D, Barroso NE, Hernandez J, Rosa-Olivares J. Behavioral Parent Training in Infancy: A Window of Opportunity for High-Risk Families. J Abnorm Child Psychol. 2016 Jul;44(5):901-12. doi: 10.1007/s10802-015-0089-5.

  PMID: 26446726 BACKGROUND

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Andrea M Chronis-Tuscano, PhD

  University of Maryland, College Park

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 23, 2021
• First Posted: April 29, 2021
• Study Start: April 22, 2021
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: April 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)