- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02432014
Parent Preferences and Family Engagement in a Conduct Problems Prevention Program
October 30, 2019 updated by: University of Minnesota
DCISR for Adaptive Intervention Models in Children's Mental Health
The purpose of this study is to gain a better understanding of family preferences for and engagement in services.
Study Overview
Status
Completed
Conditions
Detailed Description
The overarching goal of this pilot project is to elucidate factors that influence families' engagement in indicated prevention/early intervention programming for youth conduct problems.
We will explore factors previously shown to influence engagement, including parent motivational cognitions, family context variables, and preferences for intervention type.
Study aims are organized around a randomized preference trial with a parallel hybrid design structure (see Abikoff, 2001).
Families with youth ages 5-12, referred to community mental health clinics in Michigan, will be invited to participate in a prevention study.
Families who chose to participate were assigned at random to preference (i.e.
choice) or no preference (i.e.
no choice) conditions.
Those randomly assigned to the preference condition were allowed to choose between four intervention options: clinic-based services-as-usual (youth intervention); individual, home-based Oregon Parent Management Training (PMTO; Patterson, 2005), individual, clinic-based PMTO, and in-person group-based PMTO (Parenting Through Change; Forgatch & DeGarmo, 1999).
Families in the no-choice condition were randomly assigned to one of the same four conditions.
Study Type
Interventional
Enrollment (Actual)
134
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55415
- Center for Personalized Prevention Research in Children's Mental Health
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 12 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- Active psychosis
- Serious child mental health diagnosis
- Open child protection case for abuse or neglect
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: PMTO-PTC Group clinic-based
PMTO-PTC = Oregon Parent Management Training program, Parenting Through Change groups provided at a clinic.
|
Other Names:
|
Other: PMTO Individual home-based
PMTO = Oregon Parent Management Training program, delivered individually in the home.
|
Other Names:
|
Other: PMTO Individual clinic-based
PMTO = Oregon Parent Management Training program, delivered individually at a clinic.
|
Other Names:
|
Other: Services as Usual
Usual child-centered services (i.e.
therapy) provided by the agencies at a clinic.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Family Interaction Task (FIT)
Time Frame: 1 year
|
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
Time Frame: 1 year
|
Parent and Teacher Report
|
1 year
|
Brief Symptom Inventory 18 (BSI-18) Questionnaire
Time Frame: 1 year
|
Parent Report
|
1 year
|
Perceptions of Intervention Benefits and Barriers Questionnaire
Time Frame: 1 year
|
Parent Report
|
1 year
|
Parent Locus of Control Questionnaire
Time Frame: 1 year
|
Parent Report
|
1 year
|
Perceived Susceptibility & Severity Questionnaire
Time Frame: 1 year
|
Parent Report
|
1 year
|
Perceived Need to Improve Parenting Questionnaire
Time Frame: 1 year
|
Parent Report
|
1 year
|
Child Service Utilization Summary Questionnaire
Time Frame: 1 year
|
Parent Report
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Gerald August, Ph.D., University of Minnesota - P20-Center Director (PI)
- Principal Investigator: Abigail Gewirtz, Ph.D., University of Minnesota - Pilot Project PI
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2012
Primary Completion (Actual)
July 1, 2015
Study Completion (Actual)
September 1, 2015
Study Registration Dates
First Submitted
April 3, 2015
First Submitted That Met QC Criteria
April 27, 2015
First Posted (Estimate)
May 1, 2015
Study Record Updates
Last Update Posted (Actual)
November 1, 2019
Last Update Submitted That Met QC Criteria
October 30, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- 1006S83774
- P20MH085987 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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