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

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.

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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