Conduct ProblemsNCT02432014
Parent Preferences and Family Engagement in a Conduct Problems Prevention Program
A study testing PMTO-PTC Group clinic-based, PMTO Individual home-based and PMTO Individual clinic-based in people with Conduct Problems, run by University of Minnesota at 1 site in United States.
Trial summary
The purpose of this study is to gain a better understanding of family preferences for and engagement in services. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Conduct Problems
- What is being tested?
- PMTO-PTC Group clinic-based, PMTO Individual home-based and PMTO Individual clinic-based
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Sep 2015
- 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 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- Active psychosis
- Serious child mental health diagnosis
- Open child protection case for abuse or neglect
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Personalized Prevention Research in Children's Mental Health
Minneapolis, Minnesota, 55415
About this study
Official title: 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.
Read the 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.
- Conditions
- Conduct Problems
- Being tested
- PMTO-PTC Group clinic-based, PMTO Individual home-based, PMTO Individual clinic-based, Services as Usual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PMTO-PTC Group clinic-basedBehavioural
Also called PMTO-Parenting Through Change - Group
PMTO Individual home-basedBehavioural
Also called Oregon Parenting Management Training - Individual @ home
PMTO Individual clinic-basedBehavioural
Also called Oregon Parent Management Training - Individual @ clinic
Services as UsualBehavioural
| Study group | Role | What they receive |
|---|---|---|
| PMTO-PTC Group clinic-based | Other | PMTO-PTC = Oregon Parent Management Training program, Parenting Through Change groups provided at a clinic. Receives: Behavioral: PMTO-PTC Group clinic-based |
| PMTO Individual home-based | Other | PMTO = Oregon Parent Management Training program, delivered individually in the home. Receives: Behavioral: PMTO Individual home-based |
| PMTO Individual clinic-based | Other | PMTO = Oregon Parent Management Training program, delivered individually at a clinic. Receives: Behavioral: PMTO Individual clinic-based |
| Services as Usual | Other | Usual child-centered services (i.e. therapy) provided by the agencies at a clinic. Receives: Behavioral: Services as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Family Interaction Task (FIT)
Parent(s) and child participate in a number of activities which are observed and coded based on parent-child interactions.
Measured: 1 year
Strengths and Difficulties Questionnaire
Parent and Teacher Report
Measured: 1 year
Brief Symptom Inventory 18 (BSI-18) Questionnaire
Parent Report
Measured: 1 year
Perceptions of Intervention Benefits and Barriers Questionnaire
Parent Report
Measured: 1 year
Parent Locus of Control Questionnaire
Parent Report
Measured: 1 year
Perceived Susceptibility & Severity Questionnaire
Parent Report
Measured: 1 year
Perceived Need to Improve Parenting Questionnaire
Parent Report
Measured: 1 year
Child Service Utilization Summary Questionnaire
Parent Report
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2015 (estimated)
- Study startJan 2012
- Primary completionJul 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Conduct ProblemsStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Michigan Department of Community Health
- Responsible party
- Sponsor
- Investigators
- Gerald August, Ph.D., Principal investigator, University of Minnesota - P20-Center Director (PI)Abigail Gewirtz, Ph.D., Principal investigator, University of Minnesota - Pilot Project PI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02432014
- Sponsor's protocol ID
- 1006S83774
- Other IDs
- P20MH085987
- Status last verified
- Oct 2019
- First submitted
- 3 Apr 2015
- Last updated
- 1 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DCISR for Adaptive Intervention Models in Children's Mental Health
- ClinicalTrials.gov ID
- NCT02432014
- Acronym / sponsor ID
- 1006S83774
- Conditions
- Conduct Problems
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Michigan Department of Community Health
- Study start
- Jan 2012
- Primary completion
- Jul 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 1 May 2015 (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 purpose of this study is to gain a better understanding of family preferences for and engagement in services.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PMTO-PTC Group clinic-based | Other | Behavioral: PMTO-PTC Group clinic-basedPMTO-PTC = Oregon Parent Management Training program, Parenting Through Change groups provided at a clinic. |
| PMTO Individual home-based | Other | Behavioral: PMTO Individual home-basedPMTO = Oregon Parent Management Training program, delivered individually in the home. |
| PMTO Individual clinic-based | Other | Behavioral: PMTO Individual clinic-basedPMTO = Oregon Parent Management Training program, delivered individually at a clinic. |
| Services as Usual | Other | Behavioral: Services as UsualUsual child-centered services (i.e. therapy) provided by the agencies at a clinic. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (3 listed)
- Active psychosis
- Serious child mental health diagnosis
- Open child protection case for abuse or neglect
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 |
|---|---|---|
| PMTO-PTC Group clinic-basedAlso: PMTO-Parenting Through Change - Group | Behavioural | PMTO-PTC Group clinic-based |
| PMTO Individual home-basedAlso: Oregon Parenting Management Training - Individual @ home | Behavioural | PMTO Individual home-based |
| PMTO Individual clinic-basedAlso: Oregon Parent Management Training - Individual @ clinic | Behavioural | PMTO Individual clinic-based |
| Services as Usual | Behavioural | Services as Usual |
Primary outcome
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.
Strengths and Difficulties Questionnaire
Time frame: 1 year
Parent and Teacher Report
Brief Symptom Inventory 18 (BSI-18) Questionnaire
Time frame: 1 year
Parent Report
Perceptions of Intervention Benefits and Barriers Questionnaire
Time frame: 1 year
Parent Report
Parent Locus of Control Questionnaire
Time frame: 1 year
Parent Report
Perceived Susceptibility & Severity Questionnaire
Time frame: 1 year
Parent Report
Perceived Need to Improve Parenting Questionnaire
Time frame: 1 year
Parent Report
Child Service Utilization Summary Questionnaire
Time frame: 1 year
Parent Report
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 1 Nov 2019.
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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.
Gerald August, Ph.D. principal investigator
University of Minnesota - P20-Center Director (PI)
Abigail Gewirtz, Ph.D. principal investigator
University of Minnesota - Pilot Project PI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PMTO-PTC Group clinic-based, PMTO Individual home-based and PMTO Individual clinic-based in people with Conduct Problems, run by University of Minnesota at 1 site in United States.
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 2 inclusion and 3 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 1 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Family Interaction Task (FIT) (time frame: 1 year). The study lists 8 primary outcomes in all. 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 1 Nov 2019.