Oppositional Defiant DisorderNCT03260725
Evaluating the Feasibility of Internet-delivered PCIT
A study testing Parent-Child Interaction Therapy (PCIT) and Internet-delivered PCIT (I-PCIT) in people with Oppositional Defiant Disorder and Conduct Disorder, run by Florida International University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 to 5 years
- Conditions the study is for
- Oppositional Defiant Disorder, Conduct Disorder, Disruptive Behavior Disorder Nos
- What is being tested?
- Parent-Child Interaction Therapy (PCIT) and Internet-delivered PCIT (I-PCIT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2011to 31 Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida International University
Miami, Florida, 33199
About this study
Official title: Evaluating the Feasibility of Internet-delivered Parent-Child Interaction Therapy
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.
Read the 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.
- Being tested
- Parent-Child Interaction Therapy (PCIT), Internet-delivered PCIT (I-PCIT)
- Medical subject headings
- Oppositional Defiant Disorder, Conduct Disorder, Attention Deficit and Disruptive Behavior Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent-Child Interaction Therapy (PCIT)Behavioural
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.
Internet-delivered PCIT (I-PCIT)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Parent-Child Interaction Therapy (PCIT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Post-treatment (average = 35.2 weeks)
Secondary outcomes (7)
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).
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: Post-treatment (average = 35.2 weeks)
Therapy Attitude Inventory (TAI)
Parent-report of satisfaction with parent training
Measured: 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.
Measured: Baseline, mid-treatment (average = 17.2 weeks), post treatment (average = 35.2 weeks), and 6 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2017
- Study start4 Apr 2011
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oppositional Defiant DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Internet-delivered treatment v. clinic-delivered treatment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida International University
- Sponsor type
- University, hospital or other
- Collaborators
- Boston University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03260725
- Sponsor's protocol ID
- IRB-13-0451-CR01
- Status last verified
- Aug 2017
- First submitted
- 17 Aug 2017
- Last updated
- 24 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The investigators will use a controlled access approach, using a robust system to review requests and provide secure access to de-identified data.
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Feasibility of Internet-delivered Parent-Child Interaction Therapy
- ClinicalTrials.gov ID
- NCT03260725
- Acronym / sponsor ID
- IRB-13-0451-CR01
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Florida International UniversityUniversity, hospital or other
- Collaborators
- Boston University
- Study start
- 4 Apr 2011 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 24 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Internet-delivered treatment v. clinic-delivered treatment
| Arm | Type | Receives |
|---|---|---|
| Internet-delivered treatment | Experimental | Behavioral: Internet-delivered PCIT (I-PCIT)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. |
| Clinic-delivered treatment | Active comparator | Behavioral: Parent-Child Interaction Therapy (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. |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Clinic-delivered treatment |
| Internet-delivered PCIT (I-PCIT)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. | Behavioural | Internet-delivered treatment |
Primary outcome
Clinical Global Impressions (CGI) Improvement Scale
Time frame: Post-treatment (average = 35.2 weeks)
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.
7 secondary outcomes
Eyberg Child Behavior Inventory (ECBI)
Time frame: Baseline, post treatment (average = 35.2 weeks), and 6 month follow-up
Kiddie Disruptive Behavior Disorders Schedule (K-DBDS)
Time frame: Baseline, post treatment (average = 35.2 weeks), and 6 month follow-up
Barriers to Treatment Participation Scale (BTPS)
Time frame: Mid-treatment (average = 17.2 weeks) and post treatment (average = 35.2 weeks)
Children's Global Assessment Scale (CGAS)
Time frame: Baseline, post-treatment (average = 35.2 weeks), and 6 month follow-up
Client Satisfaction Questionnaire (CSQ-8)
Time frame: Post-treatment (average = 35.2 weeks)
Therapy Attitude Inventory (TAI)
Time frame: Posttreatment (average = 35.2 weeks)
Child Behavior Checklist for ages 1.5 to 5 (CBCL 1.5-5)
Time frame: Baseline, mid-treatment (average = 17.2 weeks), post treatment (average = 35.2 weeks), and 6 month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2017.
- Individual participant dataSharing planned: Undecided. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent-Child Interaction Therapy (PCIT) and Internet-delivered PCIT (I-PCIT) in people with Oppositional Defiant Disorder and Conduct Disorder, run by Florida International University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Global Impressions (CGI) Improvement Scale (time frame: Post-treatment (average = 35.2 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2017.