Open Trial of a Program to Support Parents of Children With Attention-deficit/Hyperactivity Disorder (ADHD)

NCT04636216 | Completed

• 1 other identifier: IRB-20-0484
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

Behavioral parent training is an evidence-based treatment for ADHD. The intervention can be implemented individually, or in groups. Currently, group-based parent training programs require considerable coordination, including ascertainment of a large physical space, the coordination of all families traveling to the same location at the same time, and the require for the provision of childcare. Innovations in online connectivity and ease of implementation of online support applications (e.g., Zoom) may reduce these barriers. However, it is necessary to investigate the feasibility and promise of the online approach to ensure it supports parents effectively.

Conditions

ADHD

Outcome Measures

Primary Outcomes (2)

• Observations of parenting behaviors during parent-child interaction

  Dyadic Parent Child Interaction code frequency counts for the categories of Negative Talk, Praise, and Commands

  8 weeks

• Impairment Rating Scale

  Average score across domains with scores ranging from 0 (No problem) to 6 (Extreme problem)

  8 weeks

Study Arms (1)

Community Parent Education Program (COPE) parent training program

EXPERIMENTAL

Parents will enroll in an 8-week, group parenting program.

Behavioral: COPE parent training

Interventions

COPE parent training BEHAVIORAL

Weekly 1.5 hour parent training meetings for eight weeks

Community Parent Education Program (COPE) parent training program

Eligibility Criteria

• Age: 5 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• ADHD diagnosis
• Intelligence Quotient (IQ) greater than or equal to 70
• At least 1 parent/guardian who can attend zoom sessions
• Access to reliable internet connection for zoom meetings

You may not qualify if:

• Evidence of psychosis, suicidal behaviors, or autism level 2/3

Sponsors & Collaborators

• Florida International University: lead

Study Sites (1)

Center for Children and Families

Amherst, New York, 14226, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

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

Study Officials

• Gregory A Fabiano, Ph.D.

  Florida International University

  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

Model Details: Open, single-group trial

Study Record Dates

• First Submitted: October 22, 2020
• First Posted: November 19, 2020
• Study Start: November 3, 2020
• Primary Completion: May 30, 2021
• Study Completion: May 30, 2021
• Last Updated: October 28, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)