Child Behavior ProblemsPMTONCT01795508
Parent Management Training, Oregon
A study testing PMTO and TAU in people with Child Behavior Problems, run by VIVE - The Danish Center for Social Science Research at 1 site in Denmark.
Trial summary
The purpose of the study is to examine the effects of Parent Management Training Oregon (PMTO) compared to treatment as usual (TAU) for parents with children aged 3 and 12 showing behavioral problems. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Child Behavior Problems
- What is being tested?
- PMTO and TAU
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2013to Dec 2016
- 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 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Families with children that are eligible for PMTO and at least one other type of family training program
Who cannot join
- The family does not want to participate
Trial locations and contacts
1 site in 1 country.
Denmark1 site
SFI the Danish National Centre for Social Research
Copenhagen, Copenhagen K, 1052
About this study
Official title: The Effect of Parent Management Training, Oregon, in Denmark
The purpose of the study is to examine the effects of Parent Management Training Oregon (PMTO) compared to treatment as usual (TAU) for parents with children aged 3 and 12 showing behavioral problems.
Read the detailed description
This project estimates the causal effect of Parent Management Training, Oregon (PMTO) in a Danish context. The study design is an RCT where PMTO is compared to Treatment As Usual (TAU). The target population is parents with children aged 3 and 12 showing behavioral problems. The primary outcome estimates changes in child behavior, and is measured three times: baseline, seven months follow-up, and 19 month follow-up.
- Conditions
- Child Behavior Problems
- Being tested
- PMTO, TAU
- Keywords
- Parent training, Child behavior, Randomized Controlled Trials
- Medical subject headings
- Child Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PMTOBehavioural
Parent Management Training, Oregon
TAUBehavioural
Other kinds of family training
| Study group | Role | What they receive |
|---|---|---|
| PMTO | Experimental | Parent Management Training Oregon Receives: Behavioral: PMTO |
| TAU | Active comparator | Other kinds of family treatment Receives: Behavioral: TAU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Strength and Difficulties Questionnaire (SDQ)
Measuring child behavior
Measured: 7 months post baseline
Brief Problem Monitor-Parent Form (BPM-P)
Measuring child behavior
Measured: 7 months post baseline
Secondary outcomes (5)
Parents Preference Test (PPT)
Parenting skills
Measured: 7 months post baseline
Sense of Coherence (SOC)
Measured: 7 months post baseline
Parental Stress Scale (PSS)
Measured: 7 months post baseline
Parenting Sense of Competence scale (PSOC)
Measured: 7 months post baseline
Major Depression Inventory (MDI)
Measured: 7 months post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2013 (estimated)
- Study startJan 2013
- Primary completionJul 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child Behavior ProblemsStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- VIVE - The Danish Center for Social Science Research
- Sponsor type
- University, hospital or other
- Collaborators
- National Board of Social Services, Denmark, Ministry of Social Affairs, Denmark
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01795508
- Sponsor's protocol ID
- SFI 2505
- Acronym
- PMTO
- Status last verified
- Jan 2022
- First submitted
- 18 Feb 2013
- Last updated
- 10 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Parent Management Training, Oregon, in Denmark
- ClinicalTrials.gov ID
- NCT01795508
- Acronym / sponsor ID
- PMTO / SFI 2505
- Conditions
- Child Behavior Problems
- Keywords
- Parent training, Child behavior, Randomized Controlled Trials
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- VIVE - The Danish Center for Social Science ResearchUniversity, hospital or other
- Collaborators
- National Board of Social Services, Denmark, Ministry of Social Affairs, Denmark
- Study start
- Jan 2013 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 20 Feb 2013 (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 the study is to examine the effects of Parent Management Training Oregon (PMTO) compared to treatment as usual (TAU) for parents with children aged 3 and 12 showing behavioral problems.
Detailed description
This project estimates the causal effect of Parent Management Training, Oregon (PMTO) in a Danish context. The study design is an RCT where PMTO is compared to Treatment As Usual (TAU). The target population is parents with children aged 3 and 12 showing behavioral problems. The primary outcome estimates changes in child behavior, and is measured three times: baseline, seven months follow-up, and 19 month follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PMTO | Experimental | Behavioral: PMTOParent Management Training Oregon |
| TAU | Active comparator | Behavioral: TAUOther kinds of family treatment |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Families with children that are eligible for PMTO and at least one other type of family training program
Key exclusion criteria (1 listed)
- The family does not want to participate
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 |
|---|---|---|
| PMTOParent Management Training, Oregon | Behavioural | PMTO |
| TAUOther kinds of family training | Behavioural | TAU |
Primary outcome
Strength and Difficulties Questionnaire (SDQ)
Time frame: 7 months post baseline
Measuring child behavior
Brief Problem Monitor-Parent Form (BPM-P)
Time frame: 7 months post baseline
Measuring child behavior
5 secondary outcomes
Parents Preference Test (PPT)
Time frame: 7 months post baseline
Sense of Coherence (SOC)
Time frame: 7 months post baseline
Parental Stress Scale (PSS)
Time frame: 7 months post baseline
Parenting Sense of Competence scale (PSOC)
Time frame: 7 months post baseline
Major Depression Inventory (MDI)
Time frame: 7 months post baseline
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 10 Jan 2022.
Related trials for Child Behavior Problems
Active, not recruiting
Parent-Educator Action Response
Attention Deficit and Disruptive Behavior Disorders
Not yet recruiting
Hybrid Pilot of Personalized Parent-Child Interaction Therapy
Disruptive Behaviors
Not yet recruiting
Self-Concept Reinforcement for Early School Readiness
Child Behavior, Child Behavior Problem
Recruiting
Improving Student Mental Health Through a Universal Trauma-Informed Intervention
Anxiety Symptoms, Post-traumatic Stress Symptoms
Recruiting
Optimization and Testing Effectiveness of a Collaborative Intervention for School Attendance Problems in Norwegian Municipalities
School Attendance Problems
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.
The record lists no contact. Use the official record to reach the sponsor.
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 and TAU in people with Child Behavior Problems, run by VIVE - The Danish Center for Social Science Research at 1 site in Denmark.
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 1 inclusion and 1 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 10 Jan 2022. 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 Denmark. 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?
Strength and Difficulties Questionnaire (SDQ) (time frame: 7 months post baseline). The study lists 2 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 10 Jan 2022.