- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04238403
Peer Professionals to Increase Capacity to Treat ADHD
February 26, 2020 updated by: Dr. Anil Chacko, New York University
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.
Study Overview
Status
Unknown
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
15
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
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New York
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New York, New York, United States, 10003
- Recruiting
- New York University
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Contact:
- Anil Chacko, PhD
- Phone Number: 212-992-7699
- Email: faceslab@nyu.edu
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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
No older than 99 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
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: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Behavioral Parent Training
Parent training intervention based on social learning and operant conditioning theory, generally referred to as Behavioral Parent Training.
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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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Impairment Rating Scale (IRS) immediately after the intervention
Time Frame: Assessing change from start of intervention through end of intervention at 10 weeks
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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
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Assessing change from start of intervention through end of intervention at 10 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Parenting Sense of Competence Scale (PSOC) immediately after the intervention
Time Frame: Assessing change from start of intervention through end of intervention at 10 weeks
|
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.
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Assessing change from start of intervention through end of intervention at 10 weeks
|
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Change in Alabama Parenting Questionnaire- Short Form (APQ-SF) immediately after the intervention
Time Frame: Assessing change from start of intervention through end of intervention at 10 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.
Higher scores equate to better parenting skills.
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Assessing change from start of intervention through end of intervention at 10 weeks
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Change in Beck Depression Inventory-II immediately after the intervention
Time Frame: Assessing change from start of intervention through end of intervention at 10 weeks
|
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.
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Assessing change from start of intervention through end of intervention at 10 weeks
|
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Change in Parental Stress-Short Form (PSI-SF) immediately after the intervention
Time Frame: Assessing change from start of intervention through end of intervention at 10 weeks
|
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.
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Assessing change from start of intervention through end of intervention at 10 weeks
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Change in IOWA immediately after the intervention Connors Rating Scale (IOWA-CRS)
Time Frame: Assessing change from start of intervention through end of intervention at 10 weeks
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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
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Assessing change from start of intervention through end of intervention at 10 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Anil Chacko, PhD, New York University
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)
February 26, 2020
Primary Completion (Anticipated)
November 1, 2020
Study Completion (Anticipated)
December 1, 2020
Study Registration Dates
First Submitted
December 18, 2019
First Submitted That Met QC Criteria
January 22, 2020
First Posted (Actual)
January 23, 2020
Study Record Updates
Last Update Posted (Actual)
February 28, 2020
Last Update Submitted That Met QC Criteria
February 26, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FY20203646
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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