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Evaluating the Feasibility of Internet-delivered PCIT

Primary Purpose

Oppositional Defiant Disorder, Conduct Disorder, Disruptive Behavior Disorder Nos

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Parent-Child Interaction Therapy (PCIT)
Internet-delivered PCIT (I-PCIT)
Sponsored by
Florida International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oppositional Defiant Disorder

Eligibility Criteria

3 Years - 5 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Children (ages 3-5) meeting for DSM-IV principal Oppositional Defiant Disorder (ODD) or Conduct Disorder (CD), and at least 1 primary caretaker.
  • Eyberg Child Behavior Inventory-Intensity Score in clinical range (i.e., >132).
  • English-speaking (child & caretakers).
  • Family home equipped w/ broadband connection and computer equipped with Pentium (or compatible) processor, 128 MB random-access memory (RAM), 200 Megabytes available of hard disk space, 16-bit color display adapter, universal series bus (USB) port.

Exclusion Criteria:

  • Behavior problems due to organic pathology or trauma,
  • Child receiving medication to manage behavior difficulties,
  • Presence of child emotional/behavior problem more impairing than ODD or CD,
  • Parent or child score <75 standard score on intelligence quotient (IQ) screening,
  • History of severe physical or mental impairments (e.g., mental retardation, deafness, blindness, pervasive developmental disorder) in child or participating caretaker(s).
  • Child is a ward of the state

Sites / Locations

  • Florida International University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Internet-delivered treatment

Clinic-delivered treatment

Arm Description

This treatment arm entails Internet-Delivered PCIT (I-PCIT) remotely delivered in real time using videoconferencing. Families stream live parent-child interactions from their own home to a remote therapist who provides live bug-in-the-ear parent coaching via a parent-worn Bluetooth earpiece.

This treatment arm entails Parent-Child Interaction Therapy (PCIT) delivered in the clinic. For much of the treatment, the therapist observes family interactions from behind a 1-way mirror and provides live bug-in-the-ear parent coaching via a parent-worn earpiece.

Outcomes

Primary Outcome Measures

Clinical Global Impressions (CGI) Improvement Scale
Most widely used clinician-rated measure of treatment-related changes in functioning. The CGI-Improvement rates improvement on a 7-point scale, ranging from 1 ("very much improved") to 7 ("very much worse"). CGI-Improvement scores of 1 ("very much improved") or 2 ("much improved") reflect "treatment response." CGI-Improvement scores of 1 ("very much improved") reflect "excellent response." Completed by Independent Evaluator (IE) in present study.

Secondary Outcome Measures

Eyberg Child Behavior Inventory (ECBI)
Parent-report of child behavior problems that yields an Intensity Score (indicating frequency of symptoms, scores over 132 reflect clinical range) and Problem Score (indicating how problematic symptoms are for caregivers).
Kiddie Disruptive Behavior Disorders Schedule (K-DBDS)
A supported parent interview that covers ODD, CD, and Attention-Deficit/Hyperactivity Disorder (ADHD), in preschoolers. Items are worded to maximize DSM-IV consistency, while retaining developmental appropriateness.
Barriers to Treatment Participation Scale (BTPS)
44-item parent-report measure of perceived barriers to treatment participation. Items are rated along 5-point scales and assess stressors and obstacles that compete with treatment (e.g., transportation, scheduling), treatment demands issues (e.g., uncomfortable treatment setting), and attitudes about treatment and the therapist (e.g., treatment is not working). Tallying the items yields a total barriers score
Children's Global Assessment Scale (CGAS)
Clinician-rated index of functioning. Scores range from 0-100; lower scores indicate greater impairment.
Client Satisfaction Questionnaire (CSQ-8)
Assessment of consumer satisfaction with services. Used as a parent report in present study
Therapy Attitude Inventory (TAI)
Parent-report of satisfaction with parent training
Child Behavior Checklist for ages 1.5 to 5 (CBCL 1.5-5)
Standardized instrument for assessing behavioral and emotional problems in young children, demonstrating very strong psychometric properties. Empirically based scales, normed for age and sex, are generated. T-scores below 65 reflect normative functioning.

Full Information

First Posted
August 17, 2017
Last Updated
August 21, 2017
Sponsor
Florida International University
Collaborators
Boston University
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1. Study Identification

Unique Protocol Identification Number
NCT03260725
Brief Title
Evaluating the Feasibility of Internet-delivered PCIT
Official Title
Evaluating the Feasibility of Internet-delivered Parent-Child Interaction Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
April 4, 2011 (Actual)
Primary Completion Date
December 31, 2016 (Actual)
Study Completion Date
December 31, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Florida International University
Collaborators
Boston 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 present study is leveraging a randomized-controlled design to evaluate an Internet-based format for the delivery of Parent-Child Interaction Therapy (I-PCIT). Drawing on videoteleconferencing technology, this format affords real-time interactions for the provision of care traditionally delivered in person, regardless of a family's geographic proximity to a mental health facility. Moreover, drawing on technological innovation to deliver interventions directly to families in their natural settings may extend the ecological validity of PCIT, as treatment is delivered in the very context in which child problems occur. Families seeking treatment for early child disruptive behavior problems (N=40) are being randomly assigned to either receive Internet-delivered PCIT or clinic-based PCIT. Outcomes and feasibility/acceptability will be assessed across the treatment phase as well as at post-treatment and 6-month follow-up.
Detailed Description
Establishing the feasibility of an Internet-based format for the delivery of evidence-based parent management is a critical step in the evaluation of technological innovations and their potential for advancing children's mental health care. Drawing on teleconferencing technology, such a format affords real-time interactions for the provision of care traditionally delivered in person, regardless of a family's geographic proximity to a mental health facility. Moreover, drawing on technological innovation to deliver interventions directly to families in their natural settings may extend the ecological validity of treatments, as treatments are delivered in the very contexts in which child problems occur. The objective of the present study is to develop an Internet-delivered Parent-Child Interaction Therapy (PCIT) protocol for preschoolers with Oppositional Defiant Disorder (ODD) or Conduct Disorder (CD) and to evaluate via randomized controlled trial (RCT) the feasibility and acceptability of enrolling, retaining, and treating children with I-PCIT relative to traditional PCIT. Phase I will involve development of an Internet-delivered PCIT (I-PCIT) protocol and treatment materials, including therapist treatment manual and online session handouts. Phase II will entail a case series: the PI will treat 5 consecutive preschool ODD/CD cases with I-PCIT, affording opportunity to further work out any difficulties with protocol or equipment. Phase III will entail testing the feasibility and acceptability of I-PCIT in a pilot RCT conducted with 40 children (ages 3-5) meeting for a Diagnostic and Statistical Manual (DSM-IV) principal diagnosis of ODD or CD and their parent(s) randomly assigned to I-PCIT or traditional PCIT. Parents will provide informed consent. All eligible families will receive evidence based treatment. Treatment will either be either in-clinic Parent-Child Interaction Therapy (PCIT) or Internet-delivered PCIT (I-PCIT). Formal evaluations will be conducted at baseline, post-treatment, and 6-month follow-up. Families can opt to participate in two optional psychophysiological components of the study (one involving behavioral tasks while parents are monitored via physiological equipment, and one involving play tasks while children are monitored via physiological equipment). All assessments will be conducted in the Department of Psychology at Florida International University (FIU), in the Center for Children and Families.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oppositional Defiant Disorder, Conduct Disorder, Disruptive Behavior Disorder Nos

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Internet-delivered treatment v. clinic-delivered treatment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Internet-delivered treatment
Arm Type
Experimental
Arm Description
This treatment arm entails Internet-Delivered PCIT (I-PCIT) remotely delivered in real time using videoconferencing. Families stream live parent-child interactions from their own home to a remote therapist who provides live bug-in-the-ear parent coaching via a parent-worn Bluetooth earpiece.
Arm Title
Clinic-delivered treatment
Arm Type
Active Comparator
Arm Description
This treatment arm entails Parent-Child Interaction Therapy (PCIT) delivered in the clinic. For much of the treatment, the therapist observes family interactions from behind a 1-way mirror and provides live bug-in-the-ear parent coaching via a parent-worn earpiece.
Intervention Type
Behavioral
Intervention Name(s)
Parent-Child Interaction Therapy (PCIT)
Intervention Description
PCIT is a short-term intervention that incorporates principles of play therapy into behavioral parent training, drawing on attachment and social learning theories to emphasize positive attention, consistency, problem solving, and communication. Treatment is delivered in the clinic.
Intervention Type
Behavioral
Intervention Name(s)
Internet-delivered PCIT (I-PCIT)
Intervention Description
I-PCIT is a short-term intervention that incorporates principles of play therapy into behavioral parent training, drawing on attachment and social learning theories to emphasize positive attention, consistency, problem solving, and communication. Treatment is delivered to families in their own home in real-time via videoconferencing over the Internet by a remote therapist.
Primary Outcome Measure Information:
Title
Clinical Global Impressions (CGI) Improvement Scale
Description
Most widely used clinician-rated measure of treatment-related changes in functioning. The CGI-Improvement rates improvement on a 7-point scale, ranging from 1 ("very much improved") to 7 ("very much worse"). CGI-Improvement scores of 1 ("very much improved") or 2 ("much improved") reflect "treatment response." CGI-Improvement scores of 1 ("very much improved") reflect "excellent response." Completed by Independent Evaluator (IE) in present study.
Time Frame
Post-treatment (average = 35.2 weeks)
Secondary Outcome Measure Information:
Title
Eyberg Child Behavior Inventory (ECBI)
Description
Parent-report of child behavior problems that yields an Intensity Score (indicating frequency of symptoms, scores over 132 reflect clinical range) and Problem Score (indicating how problematic symptoms are for caregivers).
Time Frame
Baseline, post treatment (average = 35.2 weeks), and 6 month follow-up
Title
Kiddie Disruptive Behavior Disorders Schedule (K-DBDS)
Description
A supported parent interview that covers ODD, CD, and Attention-Deficit/Hyperactivity Disorder (ADHD), in preschoolers. Items are worded to maximize DSM-IV consistency, while retaining developmental appropriateness.
Time Frame
Baseline, post treatment (average = 35.2 weeks), and 6 month follow-up
Title
Barriers to Treatment Participation Scale (BTPS)
Description
44-item parent-report measure of perceived barriers to treatment participation. Items are rated along 5-point scales and assess stressors and obstacles that compete with treatment (e.g., transportation, scheduling), treatment demands issues (e.g., uncomfortable treatment setting), and attitudes about treatment and the therapist (e.g., treatment is not working). Tallying the items yields a total barriers score
Time Frame
Mid-treatment (average = 17.2 weeks) and post treatment (average = 35.2 weeks)
Title
Children's Global Assessment Scale (CGAS)
Description
Clinician-rated index of functioning. Scores range from 0-100; lower scores indicate greater impairment.
Time Frame
Baseline, post-treatment (average = 35.2 weeks), and 6 month follow-up
Title
Client Satisfaction Questionnaire (CSQ-8)
Description
Assessment of consumer satisfaction with services. Used as a parent report in present study
Time Frame
Post-treatment (average = 35.2 weeks)
Title
Therapy Attitude Inventory (TAI)
Description
Parent-report of satisfaction with parent training
Time Frame
Posttreatment (average = 35.2 weeks)
Title
Child Behavior Checklist for ages 1.5 to 5 (CBCL 1.5-5)
Description
Standardized instrument for assessing behavioral and emotional problems in young children, demonstrating very strong psychometric properties. Empirically based scales, normed for age and sex, are generated. T-scores below 65 reflect normative functioning.
Time Frame
Baseline, mid-treatment (average = 17.2 weeks), post treatment (average = 35.2 weeks), and 6 month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children (ages 3-5) meeting for DSM-IV principal Oppositional Defiant Disorder (ODD) or Conduct Disorder (CD), and at least 1 primary caretaker. Eyberg Child Behavior Inventory-Intensity Score in clinical range (i.e., >132). English-speaking (child & caretakers). Family home equipped w/ broadband connection and computer equipped with Pentium (or compatible) processor, 128 MB random-access memory (RAM), 200 Megabytes available of hard disk space, 16-bit color display adapter, universal series bus (USB) port. Exclusion Criteria: Behavior problems due to organic pathology or trauma, Child receiving medication to manage behavior difficulties, Presence of child emotional/behavior problem more impairing than ODD or CD, Parent or child score <75 standard score on intelligence quotient (IQ) screening, History of severe physical or mental impairments (e.g., mental retardation, deafness, blindness, pervasive developmental disorder) in child or participating caretaker(s). Child is a ward of the state
Facility Information:
Facility Name
Florida International University
City
Miami
State/Province
Florida
ZIP/Postal Code
33199
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
The investigators will use a controlled access approach, using a robust system to review requests and provide secure access to de-identified data.

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Evaluating the Feasibility of Internet-delivered PCIT

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