Psychosocial ProblemNCT01946958
Triple P With Pediatric Residents
A study testing Training in PC Triple P and Care As Usual in people with Psychosocial Problem and Problematic Behavior in Children, run by Seattle Children's Hospital.
Trial summary
The objective of this study is to conduct a randomized control trial to evaluate the impact of Triple P on the clinic practice of pediatric residents and on select parent and child outcomes. This study will accomplish that overarching goal through addressing two specific aims. Aim 1. Read more about this study
- Who is it for?
- Ages 18 months to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychosocial Problem, Problematic Behavior in Children, Parenting
- What is being tested?
- Training in PC Triple P and Care As Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- No sites listed yet
- Study dates
- Jul 2011to Dec 2012
- 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 18 months to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Assigned to a participating continuity clinic
- Parent of an eligible child.
- Speaks English
- Treated by a participating resident
- Between 18 months and 12 years old
- Does not have any mental health diagnosis
- Is not receiving medication or therapy from a professional
Who cannot join
- Not assigned to a participating continuity clinic
- A parent of an ineligible child
- Non-English speaking
- Not treated by a participating resident
- Age falls outside of eligible range
- Has a mental health diagnosis
- Currently receiving medication or therapy from a professional
About this study
Official title: Randomized Control Study of the Impact of Primary Care Triple P on Pediatric Residents and Their Patients
The objective of this study is to conduct a randomized control trial to evaluate the impact of Triple P on the clinic practice of pediatric residents and on select parent and child outcomes. This study will accomplish that overarching goal through addressing two specific aims.
Aim 1. Triple P's Effect on Pediatric Resident's Practice: test the effect of Triple P training on practice of pediatric residents in addressing and managing psychosocial problems.
Read more
Hypothesis 1: At the completion of the trial, residents assigned to the intervention group, compared to residents exposed to the control condition, will have:
- increased skill levels,
- increased confidence, and
- increased satisfaction in dealing with and managing psychosocial issues
Aim 2. Triple P's Effect on Parent and Child Outcomes: test the effect of Triple P interventions on parent's feelings of self efficacy, parent's discipline strategies and on children's externalizing behavior.
Hypothesis 2: At the completion of the intervention, parents and children receiving the intervention, compared to those receiving the control condition, will have:
- greater reduction in targeted child behavior problems,
- greater reduction in dysfunctional parenting practices,
- increased use of appropriate discipline and positive parenting strategies, and
- greater confidence in parenting ability.
- Being tested
- Training in PC Triple P, Care As Usual
- Keywords
- Triple P
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training in PC Triple PBehavioural
PC Triple P is a brief parenting intervention combining specific advice from provider with parent rehearsal and self-evaluation.
Care As UsualOther
Pediatric residents not exposed to PC Triple P provide their standard care to parents struggling with parenting issues or child behavior concerns.
| Study group | Role | What they receive |
|---|---|---|
| Trained in Primary Care (PC) Triple P | Experimental | This group received standardized training in Primary Care (PC) Triple P. Receives: Behavioral: Training in PC Triple P |
| Care as Usal | Experimental | This group provided care as usual. This group was not trained in PC Triple P interventions. Receives: Other: Care As Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pediatric resident skills and confidence in conducting parent consultations about child behavior
Pediatric residents will complete a parent consultation skills and confidence assessment at baseline, pre-training, post-training and follow-up.
Measured: One year
Secondary outcomes (1)
Change in family outcomes - parent sense of self efficacy, use of positive discipline and child behavior
Parents participating in the study will complete an assessment about their discipline strategies, their sense of confidence as a parent and their child's behavior at baseline and follow-up.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2013 (estimated)
- Study startJul 2011
- Primary completionJun 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychosocial ProblemStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Doris Duke Charitable Foundation
- Responsible party
- Principal investigator, Fred Rivara, Seattle Children's Hospital
- Investigators
- Frederick P Rivara, MD, MPH, Principal investigator, Seattle Children's Research Institute, Seattle Children's Hospital, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01946958
- Sponsor's protocol ID
- SCH-13683
- Status last verified
- Sep 2013
- First submitted
- 6 Sep 2013
- Last updated
- 20 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Study of the Impact of Primary Care Triple P on Pediatric Residents and Their Patients
- ClinicalTrials.gov ID
- NCT01946958
- Acronym / sponsor ID
- SCH-13683
- Keywords
- Triple P
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Collaborators
- Doris Duke Charitable Foundation
- Study start
- Jul 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 20 Sep 2013 (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 objective of this study is to conduct a randomized control trial to evaluate the impact of Triple P on the clinic practice of pediatric residents and on select parent and child outcomes. This study will accomplish that overarching goal through addressing two specific aims.
Aim 1. Triple P's Effect on Pediatric Resident's Practice: test the effect of Triple P training on practice of pediatric residents in addressing and managing psychosocial problems.
Hypothesis 1: At the completion of the trial, residents assigned to the intervention group, compared to residents exposed to the control condition, will have:
- increased skill levels,
- increased confidence, and
- increased satisfaction in dealing with and managing psychosocial issues
Aim 2. Triple P's Effect on Parent and Child Outcomes: test the effect of Triple P interventions on parent's feelings of self efficacy, parent's discipline strategies and on children's externalizing behavior.
Hypothesis 2: At the completion of the intervention, parents and children receiving the intervention, compared to those receiving the control condition, will have:
- greater reduction in targeted child behavior problems,
- greater reduction in dysfunctional parenting practices,
- increased use of appropriate discipline and positive parenting strategies, and
- greater confidence in parenting ability.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trained in Primary Care (PC) Triple P | Experimental | Behavioral: Training in PC Triple PThis group received standardized training in Primary Care (PC) Triple P. |
| Care as Usal | Experimental | Other: Care As UsualThis group provided care as usual. This group was not trained in PC Triple P interventions. |
Who may qualify
- Ages
- 18 months to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Assigned to a participating continuity clinic
- Parent of an eligible child.
- Speaks English
- Treated by a participating resident
- Between 18 months and 12 years old
Key exclusion criteria (7 listed)
- Not assigned to a participating continuity clinic
- A parent of an ineligible child
- Non-English speaking
- Not treated by a participating resident
- Age falls outside of eligible range
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 |
|---|---|---|
| Training in PC Triple PPC Triple P is a brief parenting intervention combining specific advice from provider with parent rehearsal and self-evaluation. | Behavioural | Trained in Primary Care (PC) Triple P |
| Care As UsualPediatric residents not exposed to PC Triple P provide their standard care to parents struggling with parenting issues or child behavior concerns. | Other | Care as Usal |
Primary outcome
Change in pediatric resident skills and confidence in conducting parent consultations about child behavior
Time frame: One year
Pediatric residents will complete a parent consultation skills and confidence assessment at baseline, pre-training, post-training and follow-up.
1 secondary outcome
Change in family outcomes - parent sense of self efficacy, use of positive discipline and child behavior
Time frame: One year
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 20 Sep 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.
Frederick P Rivara, MD, MPH principal investigator
Seattle Children's Research Institute, Seattle Children's Hospital, University of Washington
Questions about this trial
What is this clinical trial studying?
A study testing Training in PC Triple P and Care As Usual in people with Psychosocial Problem and Problematic Behavior in Children, run by Seattle Children's Hospital.
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 7 inclusion and 7 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 20 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in pediatric resident skills and confidence in conducting parent consultations about child behavior (time frame: One year). 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 20 Sep 2013.