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Helping Toddlers and Parents Together

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ClinicalTrials.gov Identifier: NCT04864808
Recruitment Status : Recruiting
First Posted : April 29, 2021
Last Update Posted : April 29, 2021
National Institute of Mental Health (NIMH)
Children's National Research Institute
Information provided by (Responsible Party):
Andrea Chronis-Tuscano, 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.

Condition or disease Intervention/treatment Phase
ADHD Parenting Behavioral: Behavioral Parent Training Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treating ADHD Parents and Their Infants Via Telehealth: Developing an Early Parenting Intervention Using a Deployment-focused Intervention Design
Actual Study Start Date : April 22, 2021
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Parenting

Arm Intervention/treatment
Experimental: Behavioral Parenting Training Behavioral: 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.

Primary Outcome Measures :
  1. Acceptability [ Time Frame: up to 12 weeks ]
    Client Satisfaction Questionnaire (CSQ-8)- higher scores indicate more satisfaction

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Months to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04864808

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Contact: Andrea M Chronis-Tuscano, PhD 301-405-9640 achronis@umd.edu
Contact: Nicole E Lorenzo, PhD 305-812-2399 nlorenzo@umd.edu

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United States, District of Columbia
Children's National Medical Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Nicole E Lorenzo, PhD       nlorenzo@childrensnational.org   
Principal Investigator: Andrea M. Chronis, PhD         
Sponsors and Collaborators
University of Maryland, College Park
National Institute of Mental Health (NIMH)
Children's National Research Institute
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Principal Investigator: Andrea M Chronis-Tuscano, PhD University of Maryland, College Park
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Responsible Party: Andrea Chronis-Tuscano, Professor, University of Maryland, College Park
ClinicalTrials.gov Identifier: NCT04864808    
Other Study ID Numbers: R01MH118320-02S1 ( U.S. NIH Grant/Contract )
R01MH118320-02S1 ( U.S. NIH Grant/Contract )
First Posted: April 29, 2021    Key Record Dates
Last Update Posted: April 29, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No