Peer Professionals to Increase Capacity to Treat ADHD
Primary Purpose
Attention Deficit and Disruptive Behavior Disorders
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral Parent Training (MATCH Protocol)
Sponsored by
About this trial
This is an interventional treatment trial for Attention Deficit and Disruptive Behavior Disorders
Eligibility Criteria
Inclusion Criteria:
- being a parent of a child who is seeking services through a participating Vibrant Emotional Health site
- being an adult over the age of 18
- having a child between the age of 5-12
- parent must speak English, Spanish, Mandarin, and/or Cantonese.
Exclusion Criteria:
• parent presenting with severe mental health illness (e.g., schizophrenia; bipolar disorder) that would warrant immediate services.
Sites / Locations
- New York UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Behavioral Parent Training
Arm Description
Parent training intervention based on social learning and operant conditioning theory, generally referred to as Behavioral Parent Training.
Outcomes
Primary Outcome Measures
Change in Impairment Rating Scale (IRS) immediately after the intervention
Parent report on 6 point likert scale (scores 1-6 with lower scores equating to less impairment) assessing impairment associated with children's symptoms on academic, parent, family, functioning
Secondary Outcome Measures
Change in Parenting Sense of Competence Scale (PSOC) immediately after the intervention
The Parenting Sense of Competence Scale (PSOC) is an often used scale to assess parental competence in child-rearing. The PSOC has two factors: parenting efficacy and satisfaction and a total sum score for total parenting sense of competence. Seventeen items are rated on a 1 (strongly disagree) to 6 (strongly agree) scale. Higher scores equate to greater sense of parenting competence.
Change in Alabama Parenting Questionnaire- Short Form (APQ-SF) immediately after the intervention
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. Higher scores equate to better parenting skills.
Change in Beck Depression Inventory-II immediately after the intervention
The Beck Depression Inventory-II (BDI-II; Beck & Steer; 1987; Beck, Ward, Mendelsohn, Mock, & Erbaugh, 1961) is 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.
Change in Parental Stress-Short Form (PSI-SF) immediately after the intervention
The Parental Stress-Short Form (PSI-SF) is a 36-item self-report measure used to assess parenting stress in three domains, Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child. The PSI-SF is measured along a 5-point scale with one (Strongly Disagree) to five (Strongly Agree). Higher scores indicate greater levels of parenting stress. For this study, the Total Stress score, which is the sum of the three PSI-SF domains, will be used.
Change in IOWA immediately after the intervention Connors Rating Scale (IOWA-CRS)
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). Higher scores equates to higher severity of behavior problems
Full Information
NCT ID
NCT04238403
First Posted
December 18, 2019
Last Updated
February 26, 2020
Sponsor
New York University
1. Study Identification
Unique Protocol Identification Number
NCT04238403
Brief Title
Peer Professionals to Increase Capacity to Treat ADHD
Official Title
Peer Professionals to Increase Capacity to Treat ADHD
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 26, 2020 (Actual)
Primary Completion Date
November 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goal of this 1-year project is to evaluate a service delivery model by peer support organizations to increase mental health service access and utilization for children at risk for attention-deficit/hyperactivity disorder (ADHD) from socioeconomically disadvantaged, urban communities. Behavioral parent training [BPT] currently delivered directly by Family Peer Advocates (FPAs), will be evaluated in a sample of 18 families on child outcomes.
Detailed Description
The goal of this 1-year project is to further refine and evaluate an existing and employed potentially highly sustainable and scalable service delivery model that leverages peer support organizations to increase mental health service access and utilization for children at risk for attention-deficit/hyperactivity disorder (ADHD) from socioeconomically disadvantaged, urban communities by improving the delivery of an evidence-based treatment (i.e., behavioral parent training [BPT]) currently delivered directly by Family Peer Advocates (FPAs) to parents of these children. Specifically, through an iterative, single-case cohort design, the investigators will work with FPAs to iteratively refine an existing and employed intervention model with three cohorts of parents (n= 6 families/cohort over 3 cohorts with a total sample size of 18 families). the investigators will collect information from parents before, during and after BPT to assess the impact of BPT on parents perceptions of their child's behavior and functioning, and parenting factors (e.g., parenting behavior, stress, depressive symptoms). In addition, the investigators will utilize this project to gain a better understanding of how best the position the FPA ADHD Model within the broader service delivery system through qualitative interviews with these parents to assess their experience and insights into improving the model. This research project is an effort at evaluating an existing intervention model and refining it through an iterative process.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit and Disruptive Behavior Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Behavioral Parent Training
Arm Type
Experimental
Arm Description
Parent training intervention based on social learning and operant conditioning theory, generally referred to as Behavioral Parent Training.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Parent Training (MATCH Protocol)
Intervention Description
BPT. Behavioral Parent Training (BPT) is a well-established psychosocial intervention for the treatment for ADHD and related behavioral difficulties (e.g., oppositional problems). BPT is based on social learning and operant conditioning principles in which parents are instructed to utilize methods (e.g., praise, effective communication, reward systems, time-out from positive reinforcement) to facilitate positive behaviors in their child (e.g., compliance) and reduce challenging behaviors (e.g., opposition). BPT comes in several manualized, commercially available manuals. The version of BPT that we will be utilizing is from the MATCH protocol (Chorpita and Weisz, 2009), which consists of 10 components, delivered with individual families, typically over the course of 10-16 weekly individual meetings (total meetings depends upon parent availability and acquisition of BPT skills).
Primary Outcome Measure Information:
Title
Change in Impairment Rating Scale (IRS) immediately after the intervention
Description
Parent report on 6 point likert scale (scores 1-6 with lower scores equating to less impairment) assessing impairment associated with children's symptoms on academic, parent, family, functioning
Time Frame
Assessing change from start of intervention through end of intervention at 10 weeks
Secondary Outcome Measure Information:
Title
Change in Parenting Sense of Competence Scale (PSOC) immediately after the intervention
Description
The Parenting Sense of Competence Scale (PSOC) is an often used scale to assess parental competence in child-rearing. The PSOC has two factors: parenting efficacy and satisfaction and a total sum score for total parenting sense of competence. Seventeen items are rated on a 1 (strongly disagree) to 6 (strongly agree) scale. Higher scores equate to greater sense of parenting competence.
Time Frame
Assessing change from start of intervention through end of intervention at 10 weeks
Title
Change in Alabama Parenting Questionnaire- Short Form (APQ-SF) immediately after the intervention
Description
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. Higher scores equate to better parenting skills.
Time Frame
Assessing change from start of intervention through end of intervention at 10 weeks
Title
Change in Beck Depression Inventory-II immediately after the intervention
Description
The Beck Depression Inventory-II (BDI-II; Beck & Steer; 1987; Beck, Ward, Mendelsohn, Mock, & Erbaugh, 1961) is 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.
Time Frame
Assessing change from start of intervention through end of intervention at 10 weeks
Title
Change in Parental Stress-Short Form (PSI-SF) immediately after the intervention
Description
The Parental Stress-Short Form (PSI-SF) is a 36-item self-report measure used to assess parenting stress in three domains, Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child. The PSI-SF is measured along a 5-point scale with one (Strongly Disagree) to five (Strongly Agree). Higher scores indicate greater levels of parenting stress. For this study, the Total Stress score, which is the sum of the three PSI-SF domains, will be used.
Time Frame
Assessing change from start of intervention through end of intervention at 10 weeks
Title
Change in IOWA immediately after the intervention Connors Rating Scale (IOWA-CRS)
Description
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). Higher scores equates to higher severity of behavior problems
Time Frame
Assessing change from start of intervention through end of intervention at 10 weeks
10. Eligibility
Sex
All
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
being a parent of a child who is seeking services through a participating Vibrant Emotional Health site
being an adult over the age of 18
having a child between the age of 5-12
parent must speak English, Spanish, Mandarin, and/or Cantonese.
Exclusion Criteria:
• parent presenting with severe mental health illness (e.g., schizophrenia; bipolar disorder) that would warrant immediate services.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anil Chacko, PhD
Phone
2129985749
Email
anil.chacko@nyu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth Mateer, BS
Phone
2129985749
Email
emm552@nyu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anil Chacko, PhD
Organizational Affiliation
New York University
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anil Chacko, PhD
Phone
212-992-7699
Email
faceslab@nyu.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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Peer Professionals to Increase Capacity to Treat ADHD
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