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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04636216
Recruitment Status : Completed
First Posted : November 19, 2020
Last Update Posted : October 28, 2021
Sponsor:
Information provided by (Responsible Party):
Dr. Greg Fabiano, Florida International University

Study Description
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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.

Condition or disease Intervention/treatment Phase
ADHD Behavioral: COPE parent training Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Open, single-group trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Trial of a Program to Support Parents of Children With Attention-deficit/Hyperactivity Disorder in Online Group Meetings
Actual Study Start Date : November 3, 2020
Actual Primary Completion Date : May 30, 2021
Actual Study Completion Date : May 30, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Observations of parenting behaviors during parent-child interaction [ Time Frame: 8 weeks ]
    Dyadic Parent Child Interaction code frequency counts for the categories of Negative Talk, Praise, and Commands

  2. Impairment Rating Scale [ Time Frame: 8 weeks ]
    Average score across domains with scores ranging from 0 (No problem) to 6 (Extreme problem)


Eligibility Criteria
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Ages Eligible for Study:   5 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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): NCT04636216


Locations
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United States, New York
Center for Children and Families
Amherst, New York, United States, 14226
Sponsors and Collaborators
Florida International University
Investigators
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Principal Investigator: Gregory A Fabiano, Ph.D. Florida International University
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Dr. Greg Fabiano, Professor, Florida International University
ClinicalTrials.gov Identifier: NCT04636216    
Other Study ID Numbers: IRB-20-0484
First Posted: November 19, 2020    Key Record Dates
Last Update Posted: October 28, 2021
Last Verified: October 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
Additional relevant MeSH terms:
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Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders