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

Open Trial of a Program to Support Parents of Children With Attention-deficit/Hyperactivity Disorder in Online Group Meetings

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.

Study Overview

• Status: Completed
• Conditions: ADHD
• Intervention / Treatment: Behavioral: COPE parent training

Detailed Description

This study will utilize a pre-post, open trial design as the primary aim is to investigate feasibility. Approximately sixty parents will complete prepost ratings of parenting behaviors and measures of child functioning. They will also complete post treatment measures of satisfaction and open-ended questions about feasibility and suggestions for future iterations of the approach. Process measures will include data collection related to attendance and engagement in the activities. Risks include breach of confidentiality and a lack of effectiveness of the intervention for the child's presenting problems. Benefits include the parent receiving an effective intervention.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Amherst, New York, United States, 14226
      • Center for Children and Families

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 13 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Community Parent Education Program (COPE) parent training program; Parents will enroll in an 8-week, group parenting program.	Behavioral: COPE parent training; Weekly 1.5 hour parent training meetings for eight weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Florida International University
• Investigators: Principal Investigator: Gregory A Fabiano, Ph.D., Florida International University

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2020
• Primary Completion (Actual): May 30, 2021
• Study Completion (Actual): May 30, 2021

Study Registration Dates

• First Submitted: October 22, 2020
• First Submitted That Met QC Criteria: November 18, 2020
• First Posted (Actual): November 19, 2020

Study Record Updates

• Last Update Posted (Actual): October 28, 2021
• Last Update Submitted That Met QC Criteria: October 27, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity
• Other Study ID Numbers: IRB-20-0484

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No