Behavioral DisorderNCT03329625
Preventing Conduct Disorder in Child Welfare
A study testing Pathways Triple P and Services as Usual in people with Behavioral Disorder and Child Maltreatment, run by Washington University School of Medicine.
Trial summary
A mixed methods randomized control trial was conducted to test the effectiveness of Pathways Triple P with child welfare involved families compared to treatment as usual. Outcomes tested included parenting behaviors and attitudes, and child behavior problems. 144 families were recruited into the study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Behavioral Disorder, Child Maltreatment
- What is being tested?
- Pathways Triple P and Services as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- No sites listed yet
- Study dates
- 5 Jul 2010to Jul 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Families with open child protective service case following allegation of child physical abuse or neglect
- parent of child between the age of 3 and 12
- Child remained in the home following investigation
- parent spoke English
Who cannot join
- parent's child could not have chronic medical condition or have a pervasive developmental delay
About this study
Official title: PREVENTING CONDUCT DISORDER AMONG CHILDREN IN THE CHILD WELFARE SYSTEM
A mixed methods randomized control trial was conducted to test the effectiveness of Pathways Triple P with child welfare involved families compared to treatment as usual. Outcomes tested included parenting behaviors and attitudes, and child behavior problems. 144 families were recruited into the study. Data was collected at 4 time points (baseline, 4 months, 9 months, and 18 months). Over 70% were retained from baseline to 18 months.
- Conditions
- Behavioral Disorder, Child Maltreatment
- Being tested
- Pathways Triple P, Services as Usual
- Keywords
- Triple P, RCT, parent management training, Child welfare, child behavior problems
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pathways Triple PBehavioural
Pathways Triple was developed by Matt Sanders and is a behavioral parent training intervention designed to treat child behavior problems and prevent child maltreatment.
Services as UsualBehavioural
Families received family centered services and other parenting interventions as deemed appropriate by the child welfare case manager.
| Study group | Role | What they receive |
|---|---|---|
| Pathways Triple P | Experimental | Families randomized to the Pathways Triple P received a 14 week home based intervention. Receives: Behavioral: Pathways Triple P |
| Services as Usual | Active comparator | Families randomized to the services as usual condition received services as usual through the Missouri Children's Division Receives: Behavioral: Services as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eyberg Child Behavior Inventory
Child Behavior Problems
Measured: 18 months
PedsQL
Pediatric Quality of Life Scale
Measured: 18 months
Secondary outcomes (9)
Parenting Stress Inventory
Parent Stress
Measured: 18 months
Parent Anger Inventory
Parent Anger
Measured: 18 months
Parental Sense of Competence
Parent Sense of Competence
Measured: 18 months
Alabama Parenting Questionnaire
Parenting Behavior Inventory
Measured: 18 months
Depression Anxiety Stress Scales
Parental Mental Health
Measured: 18 months
AUDIT
Alcohol Abuse in Parents
Measured: 18 months
The Drug Abuse Screening Test
Parent Substance use
Measured: 18 months
HITS IPV Screening
Domestic Violence history
Measured: 18 months
PQL
Parent Report of Child Quality of Life
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start5 Jul 2010
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavioral DisorderStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patricia Kohl, Ph.D., Washington University School of Medicine
- Investigators
- Patricia Kohl, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03329625
- Sponsor's protocol ID
- 5R01HD061454
- Status last verified
- Oct 2017
- First submitted
- 30 Oct 2017
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREVENTING CONDUCT DISORDER AMONG CHILDREN IN THE CHILD WELFARE SYSTEM
- ClinicalTrials.gov ID
- NCT03329625
- Acronym / sponsor ID
- 5R01HD061454
- Conditions
- Behavioral Disorder, Child Maltreatment
- Keywords
- Triple P, RCT, parent management training, Child welfare, child behavior problems
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 5 Jul 2010 (actual)
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 6 Nov 2017 (actual)
- 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.
A mixed methods randomized control trial was conducted to test the effectiveness of Pathways Triple P with child welfare involved families compared to treatment as usual. Outcomes tested included parenting behaviors and attitudes, and child behavior problems. 144 families were recruited into the study. Data was collected at 4 time points (baseline, 4 months, 9 months, and 18 months). Over 70% were retained from baseline to 18 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pathways Triple P | Experimental | Behavioral: Pathways Triple PFamilies randomized to the Pathways Triple P received a 14 week home based intervention. |
| Services as Usual | Active comparator | Behavioral: Services as UsualFamilies randomized to the services as usual condition received services as usual through the Missouri Children's Division |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Families with open child protective service case following allegation of child physical abuse or neglect
- parent of child between the age of 3 and 12
- Child remained in the home following investigation
- parent spoke English
Key exclusion criteria (1 listed)
- parent's child could not have chronic medical condition or have a pervasive developmental delay
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 |
|---|---|---|
| Pathways Triple PPathways Triple was developed by Matt Sanders and is a behavioral parent training intervention designed to treat child behavior problems and prevent child maltreatment. | Behavioural | Pathways Triple P |
| Services as UsualFamilies received family centered services and other parenting interventions as deemed appropriate by the child welfare case manager. | Behavioural | Services as Usual |
Primary outcome
Eyberg Child Behavior Inventory
Time frame: 18 months
Child Behavior Problems
PedsQL
Time frame: 18 months
Pediatric Quality of Life Scale
9 secondary outcomes
Parenting Stress Inventory
Time frame: 18 months
Parent Anger Inventory
Time frame: 18 months
Parental Sense of Competence
Time frame: 18 months
Alabama Parenting Questionnaire
Time frame: 18 months
Depression Anxiety Stress Scales
Time frame: 18 months
AUDIT
Time frame: 18 months
The Drug Abuse Screening Test
Time frame: 18 months
HITS IPV Screening
Time frame: 18 months
PQL
Time frame: 18 months
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 6 Nov 2017.
- Individual participant dataSharing planned: No
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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.
Patricia Kohl, PhD principal investigator
Washington University School of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing Pathways Triple P and Services as Usual in people with Behavioral Disorder and Child Maltreatment, run by Washington University School of Medicine.
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 4 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 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Eyberg Child Behavior Inventory (time frame: 18 months). 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 6 Nov 2017.