Attention Deficit and Disruptive Behavior DisordersNCT04238403
Peer Professionals to Increase Capacity to Treat ADHD
A study testing Behavioral Parent Training (MATCH Protocol) in people with Attention Deficit and Disruptive Behavior Disorders, run by New York University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 99 years
- Conditions the study is for
- Attention Deficit and Disruptive Behavior Disorders
- What is being tested?
- Behavioral Parent Training (MATCH Protocol)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Feb 2020to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- parent presenting with severe mental health illness (e.g., schizophrenia; bipolar disorder) that would warrant immediate services.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
New York University
New York, New York, 10003
Anil Chacko, PhD, 212-992-7699, faceslab@nyu.edu
About this study
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.
Read the 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.
- Being tested
- Behavioral Parent Training (MATCH Protocol)
- Medical subject headings
- Attention Deficit and Disruptive Behavior Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Parent Training (MATCH Protocol)Behavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Parent Training | Experimental | Parent training intervention based on social learning and operant conditioning theory, generally referred to as Behavioral Parent Training. Receives: Behavioral: Behavioral Parent Training (MATCH Protocol) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Assessing change from start of intervention through end of intervention at 10 weeks
Secondary outcomes (5)
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.
Measured: Assessing change from start of intervention through end of intervention at 10 weeks
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.
Measured: Assessing change from start of intervention through end of intervention at 10 weeks
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.
Measured: Assessing change from start of intervention through end of intervention at 10 weeks
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.
Measured: Assessing change from start of intervention through end of intervention at 10 weeks
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
Measured: Assessing change from start of intervention through end of intervention at 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start26 Feb 2020
- Primary completionNov 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit and Disruptive Behavior DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Anil Chacko, New York University
- Investigators
- Anil Chacko, PhD, Principal investigator, New York University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04238403
- Sponsor's protocol ID
- FY20203646
- Status last verified
- Feb 2020
- First submitted
- 18 Dec 2019
- Last updated
- 28 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peer Professionals to Increase Capacity to Treat ADHD
- ClinicalTrials.gov ID
- NCT04238403
- Acronym / sponsor ID
- FY20203646
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- New York UniversityUniversity, hospital or other
- Study start
- 26 Feb 2020 (actual)
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 23 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Behavioral Parent Training | Experimental | Behavioral: Behavioral Parent Training (MATCH Protocol)Parent training intervention based on social learning and operant conditioning theory, generally referred to as Behavioral Parent Training. |
Who may qualify
- Ages
- Up to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- parent presenting with severe mental health illness (e.g., schizophrenia; bipolar disorder) that would warrant immediate services.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral Parent Training (MATCH Protocol)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). | Behavioural | Behavioral Parent Training |
Primary outcome
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
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
5 secondary outcomes
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
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anil Chacko, PhD principal investigator
New York University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Parent Training (MATCH Protocol) in people with Attention Deficit and Disruptive Behavior Disorders, run by New York University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anil Chacko, PhD (2129985749, anil.chacko@nyu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2020.