Conduct ProblemsNCT02414074
Adaptive Intervention Strategies in Conduct Problems Prevention
A study testing Youth Behavioral Intervention and Parent Education in people with Conduct Problems, run by University of Minnesota at 1 site in United States.
Trial summary
This pilot study conducts feasibility research to develop adaptive intervention strategies for conduct problems prevention. The adaptive model will stipulate for whom only brief prevention strategies are sufficient and for whom more intensive strategies are necessary. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Conduct Problems
- What is being tested?
- Youth Behavioral Intervention and Parent Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 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 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Youth ages 10-17
- Juvenile diversion referral (to community partner agency)
Who cannot join
- Pervasive developmental disabilities
- Serious psychiatric disorders requiring specialized mental health treatment (e.g. psychosis, bipolar disorder, etc.)
- Substance dependence
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
This pilot study conducts feasibility research to develop adaptive intervention strategies for conduct problems prevention. The adaptive model will stipulate for whom only brief prevention strategies are sufficient and for whom more intensive strategies are necessary. The research will involve youth (10-17 years of age) identified by law enforcement as early offenders and who are referred for pre-court juvenile diversion programming.
Read the detailed description
This project proposes to conduct feasibility research to inform implementation of a future full-scale SMART design (i.e., sequential, multiple assignment, randomized trial) that will be used to construct adaptive intervention strategies (AIS) for conduct problems prevention. AIS individualize treatment via decision rules that specify how the type (youth-focused or parent focused) or intensity (low dosage or high dosage) of an intervention should be formulated prior to the beginning of treatment based on youth and family characteristics and/or repeatedly adjusted over time based on proximal outcomes collected during treatment. AIS are needed in conduct problems prevention to address the heterogeneity of at-risk youth and the variability in response to conventional fixed-type preventive interventions. With the present SMART trial each participant will progress through two stages of intervention using a stepped-care framework. In the first stage participants will be randomized to one of two 'brief-type' intervention options, either the youth-focused Teen Intervene-Brief program (TI-B; Winters \& Leitten, 2007) or the parent-focused Everyday Parenting-Brief program (EP-B; Dishion et al., 2003, 2010). Responders to either program will be stepped down and monitored over time for maintenance. Non-responders to either program will be stepped up and randomized to one of two second stage 'intensive-type' intervention options that feature either (1) continuation of the first stage option with increased dosage (EP-Expanded or TI-Expanded), or (2) switching to the alternative expanded intervention modality. This feasibility study will enroll high risk youth (10-17 years of age) who have been arrested for status or misdemeanor offenses and referred for pre-court juvenile diversion programming. The aims of this feasibility research are to (1) develop practice infrastructure for implementing a SMART design and assess practitioner adherence to the various intervention sequences, (2) roll out the stepped-care intervention sequences and obtain estimates of recruitment into SMART, attrition at both stages, and overall response rate to first-stage intervention options, (3) describe the demographic and clinical characteristics of the sample of diversion-referred youth who are enrolled in the study, (4) create a latent construct for conduct problems that will be used as the distal outcome, and (5) explore the utility of incorporating secondary tailoring variables (e.g., child and family risk characteristics) in the adaptive intervention model.
- Conditions
- Conduct Problems
- Being tested
- Youth Behavioral Intervention, Parent Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Youth Behavioral InterventionBehavioural
Also called Teen Intervene
Teen Intervene is an early intervention program for 12-19 year olds.
Parent EducationBehavioural
Also called Everyday Parenting
Everyday Parenting is a parent training curriculum.
| Study group | Role | What they receive |
|---|---|---|
| Youth Behavioral Intervention | Other | Teen Intervene Program Receives: Behavioral: Youth Behavioral Intervention |
| Parent Education | Other | Everyday Parenting Program Receives: Behavioral: Parent Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peer Delinquency Scale
Youth Report
Measured: 9 months
Family Check-Up Youth Questionnaire - Adolescent
Youth Report
Measured: 9 months
Personal Experiences Screening Questionnaire-Adolescent
Youth Report
Measured: 9 months
Self-Reported Delinquency Scale-Adolescent (SRD)
Youth Report
Measured: 9 months
Inventory of Callous-Unemotional Traits-Youth (ICU)
Youth Report
Measured: 9 months
Delayed Discounting Task
Youth Computer Task
Measured: 9 months
Dimensional Change Card Sort Task (DCCS)
Youth Computer Task
Measured: 9 months
Flanker Task
Youth Computer Task
Measured: 9 months
Iowa Gambling Task
Youth Computer Task
Measured: 9 months
Family Check-Up Caregiver Questionnaire-Adolescent
Parent Report
Measured: 9 months
Behavior Assessment System for Children (BASC-2)
Parent Report
Measured: 9 months
Delis Rating of Executive Functions (D-REF)
Parent Report
Measured: 9 months
Family Check-Up Caregiver Questionnaire-Family
Parent Report
Measured: 9 months
Early Adolescent Temperament Questionnaire-Revised (EAT-Q)
Parent Report
Measured: 9 months
Disruptive Behavior Rating Scale (DBRS)
Parent Report
Measured: 9 months
Parenting Relationship Questionnaire (PRQ)
Parent Report
Measured: 9 months
Inventory of Callous-Unemotional Traits-Parent (ICU)
Parent Report
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2015 (estimated)
- Study startJun 2013
- Primary completionDec 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 Conduct 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), St. Paul Youth Services
- Responsible party
- Sponsor
- Investigators
- Gerald August, Ph.D., Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02414074
- Sponsor's protocol ID
- 1304S30941
- Other IDs
- R34MH097832
- Status last verified
- Oct 2019
- First submitted
- 3 Apr 2015
- Last updated
- 1 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- 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
- Adaptive Intervention Strategies in Conduct Problems Prevention
- ClinicalTrials.gov ID
- NCT02414074
- Acronym / sponsor ID
- 1304S30941
- Conditions
- Conduct Problems
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), St. Paul Youth Services
- Study start
- Jun 2013
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 10 Apr 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.
This pilot study conducts feasibility research to develop adaptive intervention strategies for conduct problems prevention. The adaptive model will stipulate for whom only brief prevention strategies are sufficient and for whom more intensive strategies are necessary. The research will involve youth (10-17 years of age) identified by law enforcement as early offenders and who are referred for pre-court juvenile diversion programming.
Detailed description
This project proposes to conduct feasibility research to inform implementation of a future full-scale SMART design (i.e., sequential, multiple assignment, randomized trial) that will be used to construct adaptive intervention strategies (AIS) for conduct problems prevention. AIS individualize treatment via decision rules that specify how the type (youth-focused or parent focused) or intensity (low dosage or high dosage) of an intervention should be formulated prior to the beginning of treatment based on youth and family characteristics and/or repeatedly adjusted over time based on proximal outcomes collected during treatment. AIS are needed in conduct problems prevention to address the heterogeneity of at-risk youth and the variability in response to conventional fixed-type preventive interventions. With the present SMART trial each participant will progress through two stages of intervention using a stepped-care framework. In the first stage participants will be randomized to one of two 'brief-type' intervention options, either the youth-focused Teen Intervene-Brief program (TI-B; Winters \& Leitten, 2007) or the parent-focused Everyday Parenting-Brief program (EP-B; Dishion et al., 2003, 2010). Responders to either program will be stepped down and monitored over time for maintenance. Non-responders to either program will be stepped up and randomized to one of two second stage 'intensive-type' intervention options that feature either (1) continuation of the first stage option with increased dosage (EP-Expanded or TI-Expanded), or (2) switching to the alternative expanded intervention modality. This feasibility study will enroll high risk youth (10-17 years of age) who have been arrested for status or misdemeanor offenses and referred for pre-court juvenile diversion programming. The aims of this feasibility research are to (1) develop practice infrastructure for implementing a SMART design and assess practitioner adherence to the various intervention sequences, (2) roll out the stepped-care intervention sequences and obtain estimates of recruitment into SMART, attrition at both stages, and overall response rate to first-stage intervention options, (3) describe the demographic and clinical characteristics of the sample of diversion-referred youth who are enrolled in the study, (4) create a latent construct for conduct problems that will be used as the distal outcome, and (5) explore the utility of incorporating secondary tailoring variables (e.g., child and family risk characteristics) in the adaptive intervention model.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Youth Behavioral Intervention | Other | Behavioral: Youth Behavioral InterventionTeen Intervene Program |
| Parent Education | Other | Behavioral: Parent EducationEveryday Parenting Program |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Youth ages 10-17
- Juvenile diversion referral (to community partner agency)
Key exclusion criteria (3 listed)
- Pervasive developmental disabilities
- Serious psychiatric disorders requiring specialized mental health treatment (e.g. psychosis, bipolar disorder, etc.)
- Substance dependence
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 |
|---|---|---|
| Youth Behavioral InterventionAlso: Teen InterveneTeen Intervene is an early intervention program for 12-19 year olds. | Behavioural | Youth Behavioral Intervention |
| Parent EducationAlso: Everyday ParentingEveryday Parenting is a parent training curriculum. | Behavioural | Parent Education |
Primary outcome
Peer Delinquency Scale
Time frame: 9 months
Youth Report
Family Check-Up Youth Questionnaire - Adolescent
Time frame: 9 months
Youth Report
Personal Experiences Screening Questionnaire-Adolescent
Time frame: 9 months
Youth Report
Self-Reported Delinquency Scale-Adolescent (SRD)
Time frame: 9 months
Youth Report
Inventory of Callous-Unemotional Traits-Youth (ICU)
Time frame: 9 months
Youth Report
Delayed Discounting Task
Time frame: 9 months
Youth Computer Task
Dimensional Change Card Sort Task (DCCS)
Time frame: 9 months
Youth Computer Task
Flanker Task
Time frame: 9 months
Youth Computer Task
Iowa Gambling Task
Time frame: 9 months
Youth Computer Task
Family Check-Up Caregiver Questionnaire-Adolescent
Time frame: 9 months
Parent Report
Behavior Assessment System for Children (BASC-2)
Time frame: 9 months
Parent Report
Delis Rating of Executive Functions (D-REF)
Time frame: 9 months
Parent Report
Family Check-Up Caregiver Questionnaire-Family
Time frame: 9 months
Parent Report
Early Adolescent Temperament Questionnaire-Revised (EAT-Q)
Time frame: 9 months
Parent Report
Disruptive Behavior Rating Scale (DBRS)
Time frame: 9 months
Parent Report
Parenting Relationship Questionnaire (PRQ)
Time frame: 9 months
Parent Report
Inventory of Callous-Unemotional Traits-Parent (ICU)
Time frame: 9 months
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.
- 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.
Gerald August, Ph.D. principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Youth Behavioral Intervention and Parent Education 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?
Peer Delinquency Scale (time frame: 9 months). The study lists 17 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.