Clinical trial NCT03260725: Evaluating the Feasibility of Internet-delivered PCIT
Official title: Evaluating the Feasibility of Internet-delivered Parent-Child Interaction Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oppositional Defiant Disorder
Conduct Disorder
Disruptive Behavior Disorder Nos
Lead sponsor: Florida International University
Sponsor class: OTHER
Collaborators: name: Boston University
First posted: 2017-08-24
Enrollment: 40
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Internet-delivered treatment v. clinic-delivered treatment
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Clinical Global Impressions (CGI) Improvement Scale
timeFrame: Post-treatment (average = 35.2 weeks)
Secondary outcomes:
measure: Eyberg Child Behavior Inventory (ECBI)
timeFrame: Baseline, post treatment (average = 35.2 weeks), and 6 month follow-up
measure: Kiddie Disruptive Behavior Disorders Schedule (K-DBDS)
timeFrame: Baseline, post treatment (average = 35.2 weeks), and 6 month follow-up
measure: Barriers to Treatment Participation Scale (BTPS)
timeFrame: Mid-treatment (average = 17.2 weeks) and post treatment (average = 35.2 weeks)
measure: Children's Global Assessment Scale (CGAS)
timeFrame: Baseline, post-treatment (average = 35.2 weeks), and 6 month follow-up
measure: Client Satisfaction Questionnaire (CSQ-8)
timeFrame: Post-treatment (average = 35.2 weeks)
measure: Therapy Attitude Inventory (TAI)
timeFrame: Posttreatment (average = 35.2 weeks)
measure: Child Behavior Checklist for ages 1.5 to 5 (CBCL 1.5-5)
timeFrame: Baseline, mid-treatment (average = 17.2 weeks), post treatment (average = 35.2 weeks), and 6 month follow-up
Other outcomes:
Locations:
city: Miami
country: United States
facility: Florida International University
state: Florida
Study officials:
References: