An interventional study of Parent-Child Interaction Therapy (PCIT) and Internet-delivered PCIT (I-PCIT) in Oppositional Defiant Disorder, Conduct Disorder and Disruptive Behavior Disorder Nos, sponsored by Florida International University. Completed at 1 site in United States. Open to participants aged 3 Years to 5 Years. Per ClinicalTrials.gov, last updated 2017-08-24.
Sponsored by Florida International University · Not applicable, Interventional, and Treatment
Among 39 studies in Oppositional Defiant Disorder with a site in United States — 7 open to participants now, 8 under way, none of them phase 3. Oppositional Defiant Disorder · United States.
Among the 39 studies in Oppositional Defiant Disorder with a site in United States, this one is the 24th largest by enrollment of the 35 interventional ones that give a count, is one of 2 that started in 2011, is one of 24 with no phase, and was the 21st registered.
86 studies on the registry are indexed under Oppositional Defiant Disorder; 16 are open to participants now.
This study's enrollment of 40 is below the median of 102 across 76 interventional studies indexed under Oppositional Defiant Disorder.
Browse Oppositional Defiant Disorder studies →7 of the 39 studies in Oppositional Defiant Disorder with a site in United States are open now.
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 13 Oppositional Defiant Disorder studies recruiting now, 2 (15%) set no upper age limit and 11 (85%) stop at 75 or younger; 11 take children under 18; 2 take healthy volunteers.
This study: 3 Years to 5 Years · all sexes · no healthy volunteers.
The full table on the hub →39 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 4 · Phase 2 2 · Phase 3 2 · Phase 4 4
First in 1999; this study’s year is marked. 2 started in 2011.
Median enrollment 86 across the 35 interventional studies, 243 across the 4 observational. Of the 29 that completed or were terminated, 8 (28%) have results posted.
2 of 39 have an industry lead sponsor. The 10 most frequent:
Florida International University is the lead sponsor of 104 studies on the registry; 20 are open to participants now.
Florida International University has 2 studies filed under Oppositional Defiant Disorder — fewer than ten, so there is no comparison to draw.
3 of the studies in Oppositional Defiant Disorder with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04946253University of PittsburghSKIP for PA Study: Team and Leadership Level Implementation Support for Collaborative Care | 2026-11 |
| NCT05647772University of PittsburghDigital Therapeutics for Behavior Problems | 2027-02 |
| NCT06831123University of MinnesotaPathways 2 Success | 2027-02-28 |
Among the 39 studies in Oppositional Defiant Disorder with a site in United States, from their registry updates:
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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)
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.
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.
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.
Time frame: Post-treatment (average = 35.2 weeks)
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).
Time frame: Baseline, post treatment (average = 35.2 weeks), and 6 month follow-up
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.
Time frame: Baseline, post treatment (average = 35.2 weeks), and 6 month follow-up
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
Time frame: Mid-treatment (average = 17.2 weeks) and post treatment (average = 35.2 weeks)
Children's Global Assessment Scale (CGAS)
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
Client Satisfaction Questionnaire (CSQ-8)
Assessment of consumer satisfaction with services. Used as a parent report in present study
Time frame: Post-treatment (average = 35.2 weeks)
Therapy Attitude Inventory (TAI)
Parent-report of satisfaction with parent training
Time frame: Posttreatment (average = 35.2 weeks)
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.
Time frame: Baseline, mid-treatment (average = 17.2 weeks), post treatment (average = 35.2 weeks), and 6 month follow-up
Plan to share: Undecided — The investigators will use a controlled access approach, using a robust system to review requests and provide secure access to de-identified data.
No publications or documents are linked to this record.
Ran from Apr 2011 to primary completion in Dec 2016, 68 months.
Of 35 non-industry interventional studies with no phase under Oppositional Defiant Disorder, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 48. This study's 68 months is above that.
Counting every sponsor, half of 36 studies reached it within 28 months; a quarter within 19 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Oppositional Defiant Disorder →
Florida International University →