- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02972086
Improving Behavioral Health Care for Children With ADHD
September 7, 2017 updated by: NYU Langone Health
Improving Behavioral Health Care for Children With ADHD: Integration of Family Peer Advocates to Deliver Behavioral Parent Training in Pediatric Care Settings
The purpose of this study is development of the Integrative Pediatric FPA ADHD Care (IPFAC) Model.
The IPFAC is intended to increase access to evidence-based behavioral parent training (BPT) for school-age children diagnosed with attention-deficit/hyperactivity disorder(ADHD) who are diagnosed with ADHD and served in the ADHD Clinic at NYU Bellevue's Department of Developmental and Behavioral Pediatrics.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The specific aims of this study are to: 1) Develop the IPFAC model (Phase I); 2) Assess and determine facilitators and barriers to fidelity, assess feasibility of data acquisition, determine preliminary efficacy, and refine the IPFAC model through a small-scale implementation study and Plan-Do-Study-Act methods (Phase II), and, 3) Evaluate the revised IPFAC model in a small-scale study using state-of-the-art single-case study design methods/analyses to test "treatment mechanisms" in a sample of newly diagnosed youth with ADHD (Phase III) and finalize the IPFAC procedural manual.
Study Type
Interventional
Enrollment (Actual)
7
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10016
- New York University School of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- being a parent of a child who is a patient at the NYU Bellevue ADHD Clinic
- being an adult over the age of 18
- having a child who obtained a diagnosis of ADHD (any subtype) within the previous 3 months (ie.., newly diagnosed) through the NYU Bellevue ADHD Clinic
- parent must speak English and/or Spanish.
The second study participant is the child. Study inclusion criteria for children include:
- child is a patient at the NYU Bellevue ADHD Clinic
- child is between the age of 6-11
- participating child must have obtained a diagnosis of ADHD (any subtype) within the previous 3 months (i.e., newly diagnosed) through the NYU Bellevue ADHD Clinic,
- child must speak English and/or Spanish.
Exclusion Criteria:
- parent presenting with severe mental health illness (e.g., schizophrenia; bipolar disorder) that would warrant immediate services.
- child with primary diagnosis/presenting issues of severe mental illness (e.g., schizophrenia; bipolar disorder) that would warrant primary services other than what is offered through the project.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Parent
Parent of a child who is a patient at the NYU Bellevue Attention Deficit Hyperactivity Disorder (ADHD) Clinic
|
A specific intervention modality that has been shown to improve key functional outcomes in youth with ADHD.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Attendance at BPT sessions
Time Frame: 16 Weeks
|
Family Practice Associates (FPAs) will provide information on the extent to which the family attended scheduled BPT sessions.
|
16 Weeks
|
|
Parenting Behavior
Time Frame: 16 Weeks
|
The Alabama Parenting Questionnaire- Short Form (APQ-SF) is a well-validated 9-item measure of parenting style.
Items are rated by the parent scored based on frequency of parenting behavior from Never (1), Almost Never (2), Sometimes (3), Often (4), Always (5).
APQ-SF items are based around the three main structures: positive parenting, inconsistent discipline and poor supervision.
|
16 Weeks
|
|
ADHD and oppositional behavior will be measured by the IOWA Connors Rating Scale (IOWA-CRS)
Time Frame: 16 Weeks
|
The IOWA-CRS (Waschbusch & Willoughby, 2008) is a widely used brief measure of attention-deficit/hyperactivity disorder and oppositional-defiant behavior in children completed by parents.
The IOWA-CRS consists of 10 items evaluated using a four-point Likert scale with the following anchors: not at all (0); just a little (1); pretty much (2); and very much (3).
|
16 Weeks
|
|
Parental Depressive Symptoms using Beck Depression Inventory-II
Time Frame: 16 Weeks
|
a 21-item self-report measure used to assess maternal depressive symptoms.
Mothers were instructed to indicate which of four statements best described how they felt over the preceding two week period.
The BDI is scored from one to four, with higher scores on the BDI indicating a greater degree of depression.
A total score on the BDI, which is a sum of the 21-item measure, will be used in the study.
|
16 Weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Karen Hopkins, MD, NYU Langone Pediatric Department
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 7, 2017
Primary Completion (ACTUAL)
August 7, 2017
Study Completion (ACTUAL)
August 7, 2017
Study Registration Dates
First Submitted
November 21, 2016
First Submitted That Met QC Criteria
November 21, 2016
First Posted (ESTIMATE)
November 23, 2016
Study Record Updates
Last Update Posted (ACTUAL)
September 11, 2017
Last Update Submitted That Met QC Criteria
September 7, 2017
Last Verified
September 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- 16-01291
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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