Childhood Disruptive Behavior DisordersTPASNCT02121431
Child and Family Outcomes and Consumer Satisfaction for Online vs Staff-Delivered Parenting Intervention
A study testing Triple P--Positive Parenting Program in people with Childhood Disruptive Behavior Disorders and Oppositional Defiant Disorder, run by University of South Carolina at 2 sites in United States.
Trial summary
This trial addresses a serious and all-too-frequent public health problem, namely early-onset disruptive behavior problems in young children. The focus is on testing an online treatment program which empowers parents to help their children to improve their mental health and behavioral functioning. Read more about this study
- Who is it for?
- Ages 3 to 7 years
- Conditions the study is for
- Childhood Disruptive Behavior Disorders, Oppositional Defiant Disorder, Conduct Disorder
- What is being tested?
- Triple P--Positive Parenting Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 334 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2014to 1 Apr 2019
- 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 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- clinically elevated level of child disruptive behavior problems
- parent resides with the child and has primary custody
- parent has access to internet via computer, e-tablet, or smartphone
Who cannot join
- already in a family-based treatment
- child has pervasive developmental disorder
- parent under 20 years of age
- parent has serious mental illness
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Parenting & Family Research Center, University of South Carolina
Columbia, South Carolina, 29208
Oregon Research Institute
Eugene, Oregon, 97403
About this study
Official title: Online vs Staff Delivery: Child & Family Outcomes, Value Analysis, Satisfaction
This trial addresses a serious and all-too-frequent public health problem, namely early-onset disruptive behavior problems in young children. The focus is on testing an online treatment program which empowers parents to help their children to improve their mental health and behavioral functioning. At the conclusion of the study, the investigators will know whether the online-delivered program works as well as an established staff-delivered program, with respect to child disruptive behavior problems, parenting, parent/family stress, consumer satisfaction, and value analysis.
Read the detailed description
High-prevalence mental health problems require innovative strategies to broaden reach of evidence-based services. Disruptive behavior problems (DBPs), or conduct problems, in young children represent a major public health challenge that is not only highly prevalent but also, left untreated, heighten risk for adverse mental health and developmental outcomes in adolescence and adulthood. Internet and online technology has considerable potential to help achieve such a goal. Building on parenting interventions that have demonstrated impact on childhood DBPs, this clinical trial compares an online-delivered intervention to a well-validated staff-delivered intervention, holding program content constant. Both interventions are based on the Triple P-Positive Parenting Program. The sample includes families with a 3-7 year old child who has a pronounced level of DBPs. The study makes use of a non-inferiority trial design to determine whether the online-delivered intervention yields as good outcomes as the well-established staff-delivered intervention with respect to childhood DBPs, parenting, and parent/family stress. The study also includes a value analysis comparing the two interventions, accounting for provider and participant expenses as well as pre-implementation and implementation phases. This study is intended to shed light on the impact and potential benefits of a viable online parenting intervention for childhood disruptive behavior problems, but the results from this study are also intended to help the mental health field to better understand more broadly the potential advantages and disadvantages of online interventions over traditionally delivered interventions, particularly in light of expense minimization/effectiveness analysis.
- Conditions
- Childhood Disruptive Behavior Disorders, Oppositional Defiant Disorder, Conduct Disorder, Attention Deficit Hyperactivity Disorder, Parent-Child Interactions
- Being tested
- Triple P--Positive Parenting Program
- Medical subject headings
- Oppositional Defiant Disorder, Conduct Disorder, Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triple P--Positive Parenting ProgramBehavioural
The Triple P--Positive Parenting Program (Triple P), which has an extensive evidence base, is grounded in a common set of core principles of positive parenting and draws on a broad menu of parenting strategies. A key provision of Triple P is that parents are the decision-makers about program goals and selection/implementation of specific parenting strategies consistent with their preferences and values.
| Study group | Role | What they receive |
|---|---|---|
| Online-Delivered Parenting Intervention | Experimental | The Online-Delivered Parenting Intervention, which is based on the Triple P--Positive Parenting Program system of interventions, is an interactive website designed to engage and activate the participant through sequenced, personalized, interactive, and video-based content. The intervention emphasizes a self-regulatory process, parent specification of goals, practical and straightforward parenting strategies, modeling, and action activation. Receives: Behavioral: Triple P--Positive Parenting Program |
| Staff-Delivered Parenting Intervention | Active comparator | The Staff-Delivered Parenting Intervention is based on the Triple P--Positive Parenting Program system and involves 10 face-to-face sessions with each family. This intervention is the well-established Level 4 Standard Triple P program. Receives: Behavioral: Triple P--Positive Parenting Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
childhood disruptive behavior problems
parental report; independent observation; teacher report
Measured: up to 12 months
Secondary outcomes (2)
parenting behavior
parental report; independent observation
Measured: baseline, 4 months (T2), 12 months (T3)
parent and family stress
parenting daily hassles; impact on family quality of life
Measured: baseline, 4 months (T2), 12 months (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2014 (estimated)
- Study startApr 2014
- Primary completion1 Apr 2019
- Study completion1 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Childhood Disruptive Behavior DisordersStudies of the same condition, open and under way.
- More trials run by University of South CarolinaThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 334 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Oregon Research Institute, University of Georgia, The University of Queensland
- Responsible party
- Principal investigator, Ron Prinz, PhD, University of South Carolina
- Investigators
- Ronald J Prinz, Ph.D., Principal investigator, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02121431
- Sponsor's protocol ID
- Pro00024933
- Acronym
- TPAS
- Status last verified
- Apr 2019
- First submitted
- 21 Apr 2014
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Ingels JB, Corso PS, Prinz RJ, Metzler CW, Sanders MR. Online-Delivered Over Staff-Delivered Parenting Intervention for Young Children With Disruptive Behavior Problems: Cost-Minimization Analysis. JMIR Pediatr Parent. 2022 Mar 11;5(1):e30795. doi: 10.2196/30795.
PubMed 35275084Prinz RJ, Metzler CW, Sanders MR, Rusby JC, Cai C. Online-delivered parenting intervention for young children with disruptive behavior problems: a noninferiority trial focused on child and parent outcomes. J Child Psychol Psychiatry. 2022 Feb;63(2):199-209. doi: 10.1111/jcpp.13426. Epub 2021 Apr 8.
PubMed 33829499
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online vs Staff Delivery: Child & Family Outcomes, Value Analysis, Satisfaction
- ClinicalTrials.gov ID
- NCT02121431
- Acronym / sponsor ID
- TPAS / Pro00024933
- Conditions
- Childhood Disruptive Behavior Disorders, Oppositional Defiant Disorder, Conduct Disorder, Attention Deficit Hyperactivity Disorder, Parent-Child Interactions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 334 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Collaborators
- Oregon Research Institute, University of Georgia, The University of Queensland
- Study start
- Apr 2014
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 23 Apr 2014 (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.
This trial addresses a serious and all-too-frequent public health problem, namely early-onset disruptive behavior problems in young children. The focus is on testing an online treatment program which empowers parents to help their children to improve their mental health and behavioral functioning. At the conclusion of the study, the investigators will know whether the online-delivered program works as well as an established staff-delivered program, with respect to child disruptive behavior problems, parenting, parent/family stress, consumer satisfaction, and value analysis.
Detailed description
High-prevalence mental health problems require innovative strategies to broaden reach of evidence-based services. Disruptive behavior problems (DBPs), or conduct problems, in young children represent a major public health challenge that is not only highly prevalent but also, left untreated, heighten risk for adverse mental health and developmental outcomes in adolescence and adulthood. Internet and online technology has considerable potential to help achieve such a goal. Building on parenting interventions that have demonstrated impact on childhood DBPs, this clinical trial compares an online-delivered intervention to a well-validated staff-delivered intervention, holding program content constant. Both interventions are based on the Triple P-Positive Parenting Program. The sample includes families with a 3-7 year old child who has a pronounced level of DBPs. The study makes use of a non-inferiority trial design to determine whether the online-delivered intervention yields as good outcomes as the well-established staff-delivered intervention with respect to childhood DBPs, parenting, and parent/family stress. The study also includes a value analysis comparing the two interventions, accounting for provider and participant expenses as well as pre-implementation and implementation phases. This study is intended to shed light on the impact and potential benefits of a viable online parenting intervention for childhood disruptive behavior problems, but the results from this study are also intended to help the mental health field to better understand more broadly the potential advantages and disadvantages of online interventions over traditionally delivered interventions, particularly in light of expense minimization/effectiveness analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Online-Delivered Parenting Intervention | Experimental | Behavioral: Triple P--Positive Parenting ProgramThe Online-Delivered Parenting Intervention, which is based on the Triple P--Positive Parenting Program system of interventions, is an interactive website designed to engage and activate the participant through sequenced, personalized, interactive, and video-based content. The intervention emphasizes a self-regulatory process, parent specification of goals, practical and straightforward parenting strategies, modeling, and action activation. |
| Staff-Delivered Parenting Intervention | Active comparator | Behavioral: Triple P--Positive Parenting ProgramThe Staff-Delivered Parenting Intervention is based on the Triple P--Positive Parenting Program system and involves 10 face-to-face sessions with each family. This intervention is the well-established Level 4 Standard Triple P program. |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- clinically elevated level of child disruptive behavior problems
- parent resides with the child and has primary custody
- parent has access to internet via computer, e-tablet, or smartphone
Key exclusion criteria (4 listed)
- already in a family-based treatment
- child has pervasive developmental disorder
- parent under 20 years of age
- parent has serious mental illness
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 |
|---|---|---|
| Triple P--Positive Parenting ProgramThe Triple P--Positive Parenting Program (Triple P), which has an extensive evidence base, is grounded in a common set of core principles of positive parenting and draws on a broad menu of parenting strategies. A key provision of Triple P is that parents are the decision-makers about program goals and selection/implementation of specific parenting strategies consistent with their preferences and values. | Behavioural | Online-Delivered Parenting Intervention, Staff-Delivered Parenting Intervention |
Primary outcome
childhood disruptive behavior problems
Time frame: up to 12 months
parental report; independent observation; teacher report
2 secondary outcomes
parenting behavior
Time frame: baseline, 4 months (T2), 12 months (T3)
parent and family stress
Time frame: baseline, 4 months (T2), 12 months (T3)
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 18 Apr 2019.
- Derived from this study: PubMed 35275084Ingels JB, Corso PS, Prinz RJ, Metzler CW, Sanders MR. Online-Delivered Over Staff-Delivered Parenting Intervention for Young Children With Disruptive Behavior Problems: Cost-Minimization Analysis. JMIR Pediatr Parent. 2022 Mar 11;5(1):e30795. doi: 10.2196/30795.
- Derived from this study: PubMed 33829499Prinz RJ, Metzler CW, Sanders MR, Rusby JC, Cai C. Online-delivered parenting intervention for young children with disruptive behavior problems: a noninferiority trial focused on child and parent outcomes. J Child Psychol Psychiatry. 2022 Feb;63(2):199-209. doi: 10.1111/jcpp.13426. Epub 2021 Apr 8.
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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.
Ronald J Prinz, Ph.D. principal investigator
University of South Carolina
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Triple P--Positive Parenting Program in people with Childhood Disruptive Behavior Disorders and Oppositional Defiant Disorder, run by University of South Carolina at 2 sites 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 3 inclusion and 4 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 18 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
childhood disruptive behavior problems (time frame: up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02121431, which also lists 2 linked publications.
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 18 Apr 2019.