Evaluating the Feasibility of Internet-delivered PCIT

NCT03260725 | Completed

• 1 other identifier: IRB-13-0451-CR01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Oppositional Defiant Disorder; Conduct Disorder; Disruptive Behavior Disorder Nos

Outcome Measures

Primary Outcomes (1)

• 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.

  Post-treatment (average = 35.2 weeks)

Secondary Outcomes (7)

• Eyberg Child Behavior Inventory (ECBI)

  Baseline, post treatment (average = 35.2 weeks), and 6 month follow-up

• Kiddie Disruptive Behavior Disorders Schedule (K-DBDS)

  Baseline, post treatment (average = 35.2 weeks), and 6 month follow-up

• Barriers to Treatment Participation Scale (BTPS)

  Mid-treatment (average = 17.2 weeks) and post treatment (average = 35.2 weeks)

• Children's Global Assessment Scale (CGAS)

  Baseline, post-treatment (average = 35.2 weeks), and 6 month follow-up

• Client Satisfaction Questionnaire (CSQ-8)

  Post-treatment (average = 35.2 weeks)

Study Arms (2)

Internet-delivered treatment

EXPERIMENTAL

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.

Behavioral: Internet-delivered PCIT (I-PCIT)

Clinic-delivered treatment

ACTIVE COMPARATOR

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.

Behavioral: Parent-Child Interaction Therapy (PCIT)

Interventions

Parent-Child Interaction Therapy (PCIT) BEHAVIORAL

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.

Clinic-delivered treatment

Internet-delivered PCIT (I-PCIT) BEHAVIORAL

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.

Internet-delivered treatment

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Florida International University: lead
• Boston University: collaborator

Study Sites (1)

Florida International University

Miami, Florida, 33199, United States

Location

MeSH Terms

Conditions

Oppositional Defiant Disorder; Conduct Disorder; Attention Deficit and Disruptive Behavior Disorders

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Internet-delivered treatment v. clinic-delivered treatment

Study Record Dates

• First Submitted: August 17, 2017
• First Posted: August 24, 2017
• Study Start: April 4, 2011
• Primary Completion: December 31, 2016
• Study Completion: December 31, 2016
• Last Updated: August 24, 2017

Record last verified: 2017-08

Locations

US (1)