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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01946958
Other study ID # SCH-13683
Secondary ID
Status Completed
Phase N/A
First received September 6, 2013
Last updated September 17, 2013
Start date July 2011
Est. completion date December 2012

Study information

Verified date September 2013
Source Seattle Children's Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical 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. 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. increased skill levels,

2. increased confidence, and

3. 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:

1. greater reduction in targeted child behavior problems,

2. greater reduction in dysfunctional parenting practices,

3. increased use of appropriate discipline and positive parenting strategies, and

4. greater confidence in parenting ability.


Recruitment information / eligibility

Status Completed
Enrollment 155
Est. completion date December 2012
Est. primary completion date June 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Months to 12 Years
Eligibility Inclusion Criteria for Pediatric Resident:

- Assigned to a participating continuity clinic

Exclusion Criteria for Pediatric Resident:

- Not assigned to a participating continuity clinic

Inclusion Criteria for Parent:

- Parent of an eligible child.

- Speaks English

Exclusion Criteria for Parent:

- A parent of an ineligible child

- Non-English speaking

Inclusion Criteria for Child:

- 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

Exclusion Criteria for Child:

- 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research


Intervention

Behavioral:
Training in PC Triple P
PC Triple P is a brief parenting intervention combining specific advice from provider with parent rehearsal and self-evaluation.
Other:
Care As Usual
Pediatric residents not exposed to PC Triple P provide their standard care to parents struggling with parenting issues or child behavior concerns.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Seattle Children's Hospital Doris Duke Charitable Foundation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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. One year No
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