Improving Behavioral Health Care for Children With ADHD

ADHD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02972086
• Other study ID #: 16-01291
• Status: Completed
• Phase: N/A
• First received: November 21, 2016
• Last updated: September 7, 2017
• Start date: January 7, 2017
• Est. completion date: August 7, 2017

Study information

• Verified date: September 2017
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: August 7, 2017
• Est. primary completion date: August 7, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• ADHD

Intervention

Behavioral:
• Behavioral Parent Training (BPT)
A specific intervention modality that has been shown to improve key functional outcomes in youth with ADHD.

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Attendance at BPT sessions	Family Practice Associates (FPAs) will provide information on the extent to which the family attended scheduled BPT sessions.	16 Weeks
Primary	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
Primary	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
Primary	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