NCT04238403

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

December 18, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 23, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

February 26, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

February 28, 2020

Status Verified

February 1, 2020

Enrollment Period

8 months

First QC Date

December 18, 2019

Last Update Submit

February 26, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    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

    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

    Assessing change from start of intervention through end of intervention at 10 weeks

  • Change in Beck Depression Inventory-II immediately after the intervention

    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

    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)

    Assessing change from start of intervention through end of intervention at 10 weeks

Study Arms (1)

Behavioral Parent Training

EXPERIMENTAL

Parent training intervention based on social learning and operant conditioning theory, generally referred to as Behavioral Parent Training.

Behavioral: Behavioral Parent Training (MATCH Protocol)

Interventions

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).

Behavioral Parent Training

Eligibility Criteria

AgeUp to 99 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • parent presenting with severe mental health illness (e.g., schizophrenia; bipolar disorder) that would warrant immediate services.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University

New York, New York, 10003, United States

RECRUITING

MeSH Terms

Conditions

Attention Deficit and Disruptive Behavior Disorders

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental Disorders

Study Officials

  • Anil Chacko, PhD

    New York University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anil Chacko, PhD

CONTACT

Elizabeth Mateer, BS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 18, 2019

First Posted

January 23, 2020

Study Start

February 26, 2020

Primary Completion

November 1, 2020

Study Completion

December 1, 2020

Last Updated

February 28, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations