Child Externalizing ProblemsPhase 2NCT01294488
Using Technology to Augment the Implementation and Effectiveness of PCIT
A Phase 2 study testing Parent-Child Interaction Therapy in people with Child Externalizing Problems, run by Centers for Disease Control and Prevention at 1 site in United States.
Trial summary
The overarching aim of the proposed study is to test the implementation effectiveness of two implementation approaches-Remote Real-Time (RRT) using the internet telemedicine technology and traditional Phone Consultation (PC) for training practitioners in PCIT. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Child Externalizing Problems
- What is being tested?
- Parent-Child Interaction Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 317 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Aug 2011
- Phase
- Phase 2
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A major inclusion criterion for agencies is existing plans and financial support for PCIT implementation because this study's resources cannot fund the phase one didactic training or clinical implementation. The proposed agencies all have existing funding, including demonstration grants, Children's Justice grant funding, state contracts, federal implementation funding, Indian Health Services funding, or SAMHSA funding specifically to support their PCIT implementation. However without the current project, none of the agency sites proposed for this study would be using RRT or assessing therapist fidelity; this study thus provides quality assurance mechanisms that would be unavailable otherwise. The agencies have reviewed and agreed to a set of agency inclusion criteria for study participation:
- The agency should be committed to developing a PCIT program, not simply training staff. There should be a commitment by leadership to the program's long-term sustainability, including sustaining the program through staff turn-over.
- The agency should identify a minimum of three staff for PCIT training (with two staff members acceptable from very small agencies that do not have three child service providers), at least one of which is a supervisor. Licensed mental health practitioner staff with a Master's degree or higher are strongly preferred, although exceptions may be made in cases where agencies do not have Master's level staff. (For example, some agencies conducting culturally relevant programs for minority or rural populations are not always able to employ licensed mental health provider staff. Because RRT may be especially salient for some of these agencies, these agencies will not be excluded from the study.)
- The agency should be committed to providing the resources and staff availability to complete the basic PCIT training package, standard PC consultation, and staff participation in approximately six months of RRT training.
- The agency should have or be in the process of developing the physical infrastructure to deliver PCIT. Physical infrastructure includes PCIT rooms with sound equipment, bug-in-the-ear equipment, and video recording equipment.
- The agency will need to have a dedicated broadband internet line for the RRT equipment.
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- The agency should be able to demonstrate that it has or will develop a referral network sufficient to provide enough PCIT cases so that therapists can develop mastery. This can include referral commitments and support from local child welfare offices, courts, schools, and so forth. If the agency plans to serve child welfare parents whose children are in foster care, it is imperative that there are firm commitments for a transportation plan. Preliminary work may be necessary to gain the cooperation of child welfare and courts to insure that service plans and court orders are consistent with PCIT (i.e. allowing joint parent-child sessions).
- The agency agrees that basic PCIT training will meet OUHSC training guidelines (to be described later).
- If clients consent to participate, the agency agrees to archive video recordings of all PCIT sessions and basic PCIT clinical measures from clients.
- The agency is in a state that agrees to provide OUHSC with child welfare outcome data.
- In the event the agency's PCIT start-up plan requires that they begin PCIT services prior to the start of the study, they will commence archiving session and client data so that early session fidelity and competency and client outcomes can be tracked. Standard PC consultation will be provided until the study begins. Session- and client-level data are routinely collected as part of PCIT implementation, to guide clinical intervention and assure quality of services. However, no data will be used for research purposes unless therapists and clients provide informed consent for its use.
- The study will retain the right to involuntarily remove an agency and its therapists from the study if PCIT implementation and data collection at the agency proves infeasible.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The overarching aim of the proposed study is to test the implementation effectiveness of two implementation approaches-Remote Real-Time (RRT) using the internet telemedicine technology and traditional Phone Consultation (PC) for training practitioners in PCIT. The study will add to emerging knowledge about how technology can facilitate the transport of evidence-based intervention models into field settings.
Read the detailed description
Parent-Child Interaction Therapy (PCIT) is an empirically supported behavioral parent training program for reducing aggressive behavior in young children and for reducing future rates of child physical abuse. Prior research has found that an adapted version of PCIT developed specifically for violent parents in the child welfare system reduced future child physical abuse recurrence rates from 49% to 19%. OUHSC/CCAN researchers, in prior and ongoing studies, have found the benefits of PCIT to be durable over time and to generalize across settings and across children in the same family. Culturally-specific adaptations of PCIT and adaptations for older abused children and their abusive parents have been developed. A number of blue-ribbon panels have recommended PCIT for widespread dissemination in child abuse prevention and intervention service systems, but uptake of PCIT has been limited. One reason for this is that the traditional PCIT practitioner training models are not easily replicable in field settings. PCIT has historically been taught in University-based training programs (graduate programs, internships, etc.) and includes several months of co-therapy mentoring where trainers work directly with trainees during live sessions. In contrast, given the difficulties of conducting co-therapy mentoring in field settings, training for widespread implementation has generally involved initial training in the model followed by phone consultation.
OUHSC/CCAN researchers have pilot- and feasibility tested a system using internet-based telemedicine technology to deliver live, mentored PCIT training. OUHSC/CCAN researchers have piloted Remote Real-Time (RRT) training at sites in Utah, Seattle, Alaska, Oregon, and Oklahoma. Feasibility appears excellent, and the approach has been well received. Moreover, RRT implementation revealed misapplications of the model that had gone unaddressed in phone consultation. This research project will make use of planned, funded PCIT start-up implementations at 20-24 agency sites in Washington and Oklahoma. Study participants will include agency practitioners engaged in implementing the PCIT model and families receiving PCIT services at these community agencies. Using a multilevel interrupted time series randomized design; the study will compare the RRT implementation approach with standard phone consultation (PC). Outcomes will include practitioner fidelity and competency in implementing PCIT, practitioner acceptance and satisfaction with PCIT, and family outcomes of parental skill acquisition, parent satisfaction, child aggressive and oppositional behaviors, and rates of future child welfare abuse reports. A mediational model is proposed in which differences in client outcomes are mediated by improved practitioner fidelity and competency. Cost effectiveness and practitioner response to the implementation approach will be examined. The study thus will inform strategies for facilitating widespread dissemination and implementation with fidelity of the evidence-based PCIT model, thereby making the model available to a broader range of agencies and practitioners working with at-risk families.
- Conditions
- Child Externalizing Problems
- Being tested
- Parent-Child Interaction Therapy
- Keywords
- PCIT, Child Maltreatment Prevention, Practitioner Fidelity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent-Child Interaction TherapyBehavioural
Therapists receive training in Parent-Child Interaction Therapy (PCIT) and receive supervision in their implementation of PCIT skills via phone consultation and polycommunication technology, each for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Phone Consultation | Experimental | Therapists receive phone consultation for 6 months during the course of the project. Receives: Behavioral: Parent-Child Interaction Therapy |
| Remote Real-Time Consultation | Experimental | Therapists receive consultation for 6 months via polycommunication technology. Receives: Behavioral: Parent-Child Interaction Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Maltreatment
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2011 (estimated)
- Study startJan 2007
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child Externalizing ProblemsStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 317 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Beverly Funderburk, Ph.D., Principal investigator, OUHSC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01294488
- Sponsor's protocol ID
- CDC-NCIPC-5085
- Status last verified
- May 2013
- First submitted
- 10 Feb 2011
- Last updated
- 8 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Technology to Augment the Implementation and Effectiveness of PCIT
- ClinicalTrials.gov ID
- NCT01294488
- Acronym / sponsor ID
- CDC-NCIPC-5085
- Conditions
- Child Externalizing Problems
- Keywords
- PCIT, Child Maltreatment Prevention, Practitioner Fidelity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 317 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Study start
- Jan 2007
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 11 Feb 2011 (estimated)
- 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 overarching aim of the proposed study is to test the implementation effectiveness of two implementation approaches-Remote Real-Time (RRT) using the internet telemedicine technology and traditional Phone Consultation (PC) for training practitioners in PCIT. The study will add to emerging knowledge about how technology can facilitate the transport of evidence-based intervention models into field settings.
Detailed description
Parent-Child Interaction Therapy (PCIT) is an empirically supported behavioral parent training program for reducing aggressive behavior in young children and for reducing future rates of child physical abuse. Prior research has found that an adapted version of PCIT developed specifically for violent parents in the child welfare system reduced future child physical abuse recurrence rates from 49% to 19%. OUHSC/CCAN researchers, in prior and ongoing studies, have found the benefits of PCIT to be durable over time and to generalize across settings and across children in the same family. Culturally-specific adaptations of PCIT and adaptations for older abused children and their abusive parents have been developed. A number of blue-ribbon panels have recommended PCIT for widespread dissemination in child abuse prevention and intervention service systems, but uptake of PCIT has been limited. One reason for this is that the traditional PCIT practitioner training models are not easily replicable in field settings. PCIT has historically been taught in University-based training programs (graduate programs, internships, etc.) and includes several months of co-therapy mentoring where trainers work directly with trainees during live sessions. In contrast, given the difficulties of conducting co-therapy mentoring in field settings, training for widespread implementation has generally involved initial training in the model followed by phone consultation.
OUHSC/CCAN researchers have pilot- and feasibility tested a system using internet-based telemedicine technology to deliver live, mentored PCIT training. OUHSC/CCAN researchers have piloted Remote Real-Time (RRT) training at sites in Utah, Seattle, Alaska, Oregon, and Oklahoma. Feasibility appears excellent, and the approach has been well received. Moreover, RRT implementation revealed misapplications of the model that had gone unaddressed in phone consultation. This research project will make use of planned, funded PCIT start-up implementations at 20-24 agency sites in Washington and Oklahoma. Study participants will include agency practitioners engaged in implementing the PCIT model and families receiving PCIT services at these community agencies. Using a multilevel interrupted time series randomized design; the study will compare the RRT implementation approach with standard phone consultation (PC). Outcomes will include practitioner fidelity and competency in implementing PCIT, practitioner acceptance and satisfaction with PCIT, and family outcomes of parental skill acquisition, parent satisfaction, child aggressive and oppositional behaviors, and rates of future child welfare abuse reports. A mediational model is proposed in which differences in client outcomes are mediated by improved practitioner fidelity and competency. Cost effectiveness and practitioner response to the implementation approach will be examined. The study thus will inform strategies for facilitating widespread dissemination and implementation with fidelity of the evidence-based PCIT model, thereby making the model available to a broader range of agencies and practitioners working with at-risk families.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phone Consultation | Experimental | Behavioral: Parent-Child Interaction TherapyTherapists receive phone consultation for 6 months during the course of the project. |
| Remote Real-Time Consultation | Experimental | Behavioral: Parent-Child Interaction TherapyTherapists receive consultation for 6 months via polycommunication technology. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- A major inclusion criterion for agencies is existing plans and financial support for PCIT implementation because this study's resources cannot fund the phase one didactic training or clinical implementation. The proposed agencies all have existing funding, including demonstration grants, Children's Justice grant funding, state contracts, federal implementation funding, Indian Health Services funding, or SAMHSA funding specifically to support their PCIT implementation. However without the current project, none of the agency sites proposed for this study would be using RRT or assessing therapist fidelity; this study thus provides quality assurance mechanisms that would be unavailable otherwise. The agencies have reviewed and agreed to a set of agency inclusion criteria for study participation:
- The agency should be committed to developing a PCIT program, not simply training staff. There should be a commitment by leadership to the program's long-term sustainability, including sustaining the program through staff turn-over.
- The agency should identify a minimum of three staff for PCIT training (with two staff members acceptable from very small agencies that do not have three child service providers), at least one of which is a supervisor. Licensed mental health practitioner staff with a Master's degree or higher are strongly preferred, although exceptions may be made in cases where agencies do not have Master's level staff. (For example, some agencies conducting culturally relevant programs for minority or rural populations are not always able to employ licensed mental health provider staff. Because RRT may be especially salient for some of these agencies, these agencies will not be excluded from the study.)
- The agency should be committed to providing the resources and staff availability to complete the basic PCIT training package, standard PC consultation, and staff participation in approximately six months of RRT training.
- The agency should have or be in the process of developing the physical infrastructure to deliver PCIT. Physical infrastructure includes PCIT rooms with sound equipment, bug-in-the-ear equipment, and video recording equipment.
Key exclusion criteria (0 listed)
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 TherapyTherapists receive training in Parent-Child Interaction Therapy (PCIT) and receive supervision in their implementation of PCIT skills via phone consultation and polycommunication technology, each for 6 months. | Behavioural | Phone Consultation, Remote Real-Time Consultation |
Primary outcome
Child Maltreatment
Time frame: 12 months
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 8 May 2013.
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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.
Beverly Funderburk, Ph.D. principal investigator
OUHSC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Parent-Child Interaction Therapy in people with Child Externalizing Problems, run by Centers for Disease Control and Prevention 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 12 inclusion and 0 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 8 May 2013. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Child Maltreatment (time frame: 12 months). 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 8 May 2013.