NCT02432014

Brief Summary

The purpose of this study is to gain a better understanding of family preferences for and engagement in services.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
134

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

April 3, 2015

Completed
28 days until next milestone

First Posted

Study publicly available on registry

May 1, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

November 1, 2019

Status Verified

October 1, 2019

Enrollment Period

3.5 years

First QC Date

April 3, 2015

Last Update Submit

October 30, 2019

Conditions

Outcome Measures

Primary Outcomes (8)

  • Family Interaction Task (FIT)

    Parent(s) and child participate in a number of activities which are observed and coded based on parent-child interactions.

    1 year

  • Strengths and Difficulties Questionnaire

    Parent and Teacher Report

    1 year

  • Brief Symptom Inventory 18 (BSI-18) Questionnaire

    Parent Report

    1 year

  • Perceptions of Intervention Benefits and Barriers Questionnaire

    Parent Report

    1 year

  • Parent Locus of Control Questionnaire

    Parent Report

    1 year

  • Perceived Susceptibility & Severity Questionnaire

    Parent Report

    1 year

  • Perceived Need to Improve Parenting Questionnaire

    Parent Report

    1 year

  • Child Service Utilization Summary Questionnaire

    Parent Report

    1 year

Study Arms (4)

PMTO-PTC Group clinic-based

OTHER

PMTO-PTC = Oregon Parent Management Training program, Parenting Through Change groups provided at a clinic.

Behavioral: PMTO-PTC Group clinic-based

PMTO Individual home-based

OTHER

PMTO = Oregon Parent Management Training program, delivered individually in the home.

Behavioral: PMTO Individual home-based

PMTO Individual clinic-based

OTHER

PMTO = Oregon Parent Management Training program, delivered individually at a clinic.

Behavioral: PMTO Individual clinic-based

Services as Usual

OTHER

Usual child-centered services (i.e. therapy) provided by the agencies at a clinic.

Behavioral: Services as Usual

Interventions

Also known as: PMTO-Parenting Through Change - Group
PMTO-PTC Group clinic-based
Also known as: Oregon Parenting Management Training - Individual @ home
PMTO Individual home-based
Also known as: Oregon Parent Management Training - Individual @ clinic
PMTO Individual clinic-based
Services as Usual

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Families with at least one child between the ages of 5 and 12.
  • Referral to community mental health clinic (specifically, to one of the project partner clinics)

You may not qualify if:

  • Active psychosis
  • Serious child mental health diagnosis
  • Open child protection case for abuse or neglect

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Personalized Prevention Research in Children's Mental Health

Minneapolis, Minnesota, 55415, United States

Location

Study Officials

  • Gerald August, Ph.D.

    University of Minnesota - P20-Center Director (PI)

    PRINCIPAL INVESTIGATOR
  • Abigail Gewirtz, Ph.D.

    University of Minnesota - Pilot Project PI

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2015

First Posted

May 1, 2015

Study Start

January 1, 2012

Primary Completion

July 1, 2015

Study Completion

September 1, 2015

Last Updated

November 1, 2019

Record last verified: 2019-10

Locations