Helping Toddlers and Parents Together

NCT ID: NCT04864808

Last Updated: 2025-04-15

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-22
• Study Completion Date: 2025-03-01

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.

Conditions

ADHD; Parenting

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Behavioral Parenting Training

Group Type: EXPERIMENTAL

Behavioral Parent Training

Intervention Type: 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.

Interventions

Behavioral Parent Training

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Children's National Research Institute

OTHER

Sponsor Role: collaborator

University of Maryland, College Park

OTHER

Sponsor Role: lead

Responsible Party

Andrea Chronis-Tuscano

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrea M Chronis-Tuscano, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Maryland, College Park

Locations

Children's National Medical Center

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

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 21537894 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26446726 (View on PubMed)

Other Identifiers

R01MH118320-02S1

Identifier Type: NIH

Identifier Source: secondary_id

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R01MH118320-02S1

Identifier Type: NIH

Identifier Source: org_study_id

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