NCT02972086

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 21, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 23, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

January 7, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 7, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 7, 2017

Completed
Last Updated

September 11, 2017

Status Verified

September 1, 2017

Enrollment Period

7 months

First QC Date

November 21, 2016

Last Update Submit

September 7, 2017

Conditions

ADHD

Outcome Measures

Primary Outcomes (4)

  • Attendance at BPT sessions

    Family Practice Associates (FPAs) will provide information on the extent to which the family attended scheduled BPT sessions.

    16 Weeks

  • Parenting Behavior

    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)

    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

    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

Study Arms (1)

Parent

EXPERIMENTAL

Parent of a child who is a patient at the NYU Bellevue Attention Deficit Hyperactivity Disorder (ADHD) Clinic

Behavioral: Behavioral Parent Training (BPT)

Interventions

Behavioral Parent Training (BPT)BEHAVIORAL

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

Parent

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Karen Hopkins, MD

    NYU Langone Pediatric Department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2016

First Posted

November 23, 2016

Study Start

January 7, 2017

Primary Completion

August 7, 2017

Study Completion

August 7, 2017

Last Updated

September 11, 2017

Record last verified: 2017-09

Locations

US(1)