NCT01946958

Brief 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. 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:

  1. 1.increased skill levels,
  2. 2.increased confidence, and
  3. 3.increased satisfaction in dealing with and managing psychosocial issues
  4. 4.greater reduction in targeted child behavior problems,
  5. 5.greater reduction in dysfunctional parenting practices,
  6. 6.increased use of appropriate discipline and positive parenting strategies, and
  7. 7.greater confidence in parenting ability.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
155

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2011

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 20, 2013

Completed
Last Updated

September 20, 2013

Status Verified

September 1, 2013

Enrollment Period

11 months

First QC Date

September 6, 2013

Last Update Submit

September 17, 2013

Conditions

Keywords

Triple P

Outcome Measures

Primary Outcomes (1)

  • 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.

    One year

Secondary Outcomes (1)

  • Change in family outcomes - parent sense of self efficacy, use of positive discipline and child behavior

    One year

Study Arms (2)

Trained in Primary Care (PC) Triple P

EXPERIMENTAL

This group received standardized training in Primary Care (PC) Triple P.

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.

Other: Care As Usual

Interventions

PC Triple P is a brief parenting intervention combining specific advice from provider with parent rehearsal and self-evaluation.

Trained in Primary Care (PC) Triple P

Pediatric residents not exposed to PC Triple P provide their standard care to parents struggling with parenting issues or child behavior concerns.

Care as Usal

Eligibility Criteria

Age18 Months - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Assigned to a participating continuity clinic

You may not qualify if:

  • Not assigned to a participating continuity clinic
  • Parent of an eligible child.
  • Speaks English
  • A parent of an ineligible child
  • Non-English speaking
  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Frederick P Rivara, MD, MPH

    Seattle Children's Research Institute, Seattle Children's Hospital, University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 6, 2013

First Posted

September 20, 2013

Study Start

July 1, 2011

Primary Completion

June 1, 2012

Study Completion

December 1, 2012

Last Updated

September 20, 2013

Record last verified: 2013-09