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Completed

NCT Number: NCT02972086

Improving Behavioral Health Care for Children With ADHD

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.

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Key information

Conditions

ADHD Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York University School of Medicine

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Behavioral Parent Training (BPT)

Behavioral

A specific intervention modality that has been shown to improve key functional outcomes in youth with ADHD.

Primary outcomes

  1. 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.

  2. 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.

  3. 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).

  4. 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.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

Improving Behavioral Health Care for Children With ADHD: Integration of Family Peer Advocates to Deliver Behavioral Parent Training in Pediatric Care Settings

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Nov 23, 2016
Registry last updated
Sep 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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