Oppositional Defiant DisorderREACHNCT00820001
Resources to Enhance the Adjustment of Children (REACH)
A study testing Booster Treatment, No-Booster and Treatment As Usual in people with Oppositional Defiant Disorder and Conduct Disorder, run by University of Pittsburgh at 2 sites in United States.
Trial summary
This continuation study evaluates the long-term outcomes of multimodal, modular interventions with early-onset behavior disordered children and innovative methods to promote the maintenance and extension of treatment effects relating to ODD and CD. Read more about this study
- Who is it for?
- Ages 6 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Oppositional Defiant Disorder, Conduct Disorder, Attention Deficit Hyperactivity Disorder
- What is being tested?
- Booster Treatment, No-Booster and Treatment As Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 254 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2003to Nov 2009
- 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 6 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- males or females with an age of 6-11 years,
- a DSM-IV diagnosis of CD or ODD,
- residence with at least one parent/guardian;
- intellectual level no less than two SD's below age norms; and
- parent consent for participation.
Who cannot join
- concurrent individual or family participation in a treatment program directed towards the child's disruptive disorders,
- current psychosis, bipolar disorder, or MDD marked by significant vegetative signs,
- suicidality with a plan or homicidality; or
- substance abuse or an eating disorder.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Bellefield Towers - Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Enhancing Long-Term Outcome in Child Behavior Disorders
This continuation study evaluates the long-term outcomes of multimodal, modular interventions with early-onset behavior disordered children and innovative methods to promote the maintenance and extension of treatment effects relating to ODD and CD. All participants originally enrolled in the "parent" clinical trial are being followed and those who initially received clinic or community based intervention from a study clinician were randomly assigned to either Booster or No-booster treatment condition. The treatment-as-usual (TAU) and Healthy Control participants were also followed through long-term follow-up assessments paralleling clinically referred participants. The study examines the short and long-term efficacy of booster treatment on clinical outcome, contextual variables, and service satisfaction/use.
Read the detailed description
Child Conduct problems (CP), as found in Conduct Disorder (CD) and Oppositional Defiant Disorder (ODD), are common and chronic. Although laboratory research studies have yielded promising initial outcomes, follow-up effects are often not studied and, when they are evaluated, are often limited. Maintenance procedures have been generally administered after acute treatment in the form of periodic booster sessions to enhance long-term outcomes (Whisman, 1990). Although the conceptualization and application of maintenance therapies has been described frequently with adults, there is limited information regarding the role of maintenance treatment in child and adolescent psychotherapy (see Eyeberg, 1998). A few studies of booster treatments have reported the return of behavioral improvements (Baer, Williams, Osnes, \& Stokes, 1984; McDonald \& Budd, 1983; Patterson, 1974) and other improvements in conduct-disordered children (Lochman, 1992) and depressed adolescents (Clark et al., 1999), suggesting potential benefits in extending the durability of treatment effects. What is not yet known is the extent to which patients respond positively to a booster (maintenance) treatment condition that is administered after long-term (i.e., three-year) follow-up, one that is designed to reduce recurrence of behavioral dysfunction and the development of new forms of dysfunction during adolescence. The justification for this additional intervention derives from our initial findings and the young age of our sample, which, in most instances, has yet to traverse the period of heightened risk for delinquency.
Literature reviews highlight the importance of addressing at least three primary objectives in understanding the clinical response and long-term adjustment of children with ODD or CD. First, there is a need to document empirically the long-term effects of both specialty treatments and routine services during repeated follow-up assessments in an effort to document the maintenance of all initial treatment gains (Eyberg et al., 1998). Our preliminary findings suggesting the presence of both similarities and differences in the initial outcomes of our two specialty treatments (Community vs. Clinic protocols) supports the conduct of a long-term evaluation in order to determine whether these effects continue or change.
Second, our initial findings underscore the importance of determining the extent to which booster treatment sessions help to promote long-term maintenance or produce long-term preventive effects on some of the more common sequelae of ODD and CD. Booster treatment may be needed to deflect such children from unfolding trajectories toward increased antisocial behavior and multi-system impairments (Loeber et al., 1993). Thus, efforts to promote the long-term outcomes of follow-up in this population must be evaluated in an effort to understand the degree to which they show improvements in serious clinical dysfunction (recovery from Disruptive Behavior Disorders (DBD)) and/or show reductions in the development of new forms of dysfunction (deviant and delinquent activities) that may place these children at-risk for other adverse adolescent outcomes. The young age of this patient sample at the start of this competing continuation(8-16 yrs) may make it easier to demonstrate preventive effects.
Finally, the availability of only modest empirical evidence provides a compelling argument for evaluating potential predictors of each of the above-mentioned long-term follow-up outcomes based on a comprehensive battery of psychosocial (e.g., child, parent, and family adjustment) and biological (e.g., testosterone, cortisol) measures obtained upon study intake and treatment termination. Key predictors of treatment response include lower levels of child, parent, and family dysfunction, barriers to treatment, and SES (Kazdin, 1995; Kazdin \& Wassell, 2000). We will also evaluate the role of contextual or other life changes in understanding treatment effects over the follow up period. Among the important contextual variables to be evaluated include changes in parental and family functioning, peer relationships, and school adjustment. Clearly, these variables may influence continued antisocial behavior at this young age. Thus, we will examine how contextual factors affect how well treatment effects hold as well as the real world impact of treatment on various life changes.
- Being tested
- Booster Treatment, No-Booster, No intervention, Treatment As Usual
- Keywords
- Cognitive Behavioral Therapy, Multimodal Treatment, Physiological Parameters, Hormone Concentration in pubertal development, Treatment as usual comparison
- Medical subject headings
- Oppositional Defiant Disorder, Conduct Disorder, Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Booster TreatmentBehavioural
Also called Modular Cognitive Behavior Therapy
Based on this collective evidence, booster treatment was designed to address three general goals: a) clarify key child and parent/family problems and family preferences regarding target problems, b) directly target and resolve these existing problems using the eight domains contained in the existing treatment protocol administered in the initial outcome study, and c) provide the family with clinical recommendations and information to promote the maintenance of skill developments in targeted domains or adaptive routines designed to prevent any further deterioration in clinical functioning. Thus, the clinician may provide a review of prior content or administer new material specifically for older adolescents, as needed, and will attempt to apply these skills to specific problematic situations identified by the family.
No-BoosterBehavioural
Also called No-Booster Comparison condition
All cases randomized to this condition will simply participate in all of the proposed routine assessments and will receive assessment feedback. Specifically, these families will be provided with a brief summary of the significant clinical findings obtained in their 36-month follow-up assessment (assessment feedback). Such an assessment was provided to clinicians in the original study in order to highlight specific areas in need of clinical attention based on a review of the normative data and clinical cutoffs available for each instrument. Selected information will be conveyed by phone to the participating parent/guardian in a straightforward manner followed by a discussion of some clinical recommendations designed to address these clinical problems. In addition, the parent/guardian will be provided with a listing of professionals who provide services appropriate for this age group and for children with similar problems.
No interventionOther
Also called Healthy Control Comparison Group
No intervention was administered with this arm. Saliva samples were collected 2 times in the lab and 2 times at home (once at bedtime, once at wake-up time) per initial voluntary saliva protocol at each timepoints to measure endocrine levels.
Treatment As UsualOther
Also called Treatment As Usual clinical comparison.
All cases assigned to this arm simply participated in all of the proposed routine assessments.
| Study group | Role | What they receive |
|---|---|---|
| Acute Treatment Protocol Booster | Experimental | Child participants in this arm were initial participants enrolled in the parent study and randomized to receive the specialty treatment from study clinicians in either the clinic or community setting. In this continuation study, the participants were enrolled at the 36 month assessment and randomized to participate in the booster dose of treatment. The treatment provided in this arm includes specific booster treatment based on the 8 modules of the initial treatment study. Saliva samples were also collected 2 times in the lab and 2 times at home (once at bedtime, once at wake-up time) per initial voluntary saliva protocol at each timepoints to measure endocrine levels. Receives: Behavioral: Booster Treatment |
| Acute Treatment Protocol No-Booster | Experimental | Child participants in this arm were initial participants enrolled in the parent study and randomized to receive the specialty treatment from study clinicians in either the clinic or community setting. In this continuation study, the participants were enrolled at the 36 month assessment and randomized to participate in assessments only thus not receiving any additional booster treatment. Saliva samples were collected 2 times in the lab and 2 times at home (once at bedtime, once at wake-up time) per initial voluntary saliva protocol at each timepoints to measure endocrine levels. Receives: Behavioral: No-Booster |
| Treatment As Usual | Active comparator | Child participants in this arm were initial participants enrolled in the parent study in the clinically referred Treatment As Usual comparison group. These participants were initially enrolled in treatment services with identified providers and received treatment services as provided in that community agency. In this continuation study, the participants were enrolled at the 36 month assessment and participated in the ongoing follow-up assessments only. Saliva samples were collected 2 times in the lab and 2 times at home (once at bedtime, once at wake-up time) per initial voluntary saliva protocol at each timepoints to measure endocrine levels. Receives: Other: Treatment As Usual |
| No Intervention Healthy Comparison | Other | The Healthy Control subjects enrolled initially in the parent study are incorporated in a related project designed to evaluate the role of biological measures in differentiating antisocial and normal children. All Healthy Control participants were initially matched to cases in the clinical sample (both the acute treatment and the clinically referred Treatment as Usual). Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Individualized child problem targets and externalizing behavior including functional impairment
Measured: Baseline for continuation (36 months into study participation) and at months 42, 48, 54, 66 (assessment timeline is inclusive of all assessments for parent and continuation trials)
Peer and Family Characteristics
Measured: Assessed at all follow-up timepoints including baseline (36 month assessment) and all subsequent follow-up assessments at months 42, 48, 54 and 66.
Parental Disfunction
Measured: Assessed at all timepoints including baseline (36 month) and follow-up assessments at months 42, 48, 54, and 66
Secondary outcomes (2)
Teacher reports of child functioning
Measured: Assessed at all timepoints including baseline (36 month) and follow-up assessments at months 42, 48, 54, and 66
Child attentional and internalizing problems
Measured: Assessed at all timepoints including baseline (36 month) and follow-up assessments at months 42, 48, 54, and 66
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2009 (estimated)
- Study startDec 2003
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Oppositional Defiant DisorderStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 254 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital Medical Center, Cincinnati
- Responsible party
- Principal investigator, David Kolko, University of Pittsburgh
- Investigators
- David J Kolko, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00820001
- Sponsor's protocol ID
- R01MH057727
- Acronym
- REACH
- Status last verified
- Feb 2013
- First submitted
- 7 Jan 2009
- Last updated
- 18 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Kolko DJ, Dorn LD, Bukstein OG, Pardini D, Holden EA, Hart J. Community vs. clinic-based modular treatment of children with early-onset ODD or CD: a clinical trial with 3-year follow-up. J Abnorm Child Psychol. 2009 Jul;37(5):591-609. doi: 10.1007/s10802-009-9303-7.
PubMed 19221871Diler RS, Birmaher B, Axelson D, Goldstein B, Gill M, Strober M, Kolko DJ, Goldstein TR, Hunt J, Yang M, Ryan ND, Iyengar S, Dahl RE, Dorn LD, Keller MB. The Child Behavior Checklist (CBCL) and the CBCL-bipolar phenotype are not useful in diagnosing pediatric bipolar disorder. J Child Adolesc Psychopharmacol. 2009 Feb;19(1):23-30. doi: 10.1089/cap.2008.067.
PubMed 19232020Dorn LD, Kolko DJ, Shenk CE, Susman EJ, Bukstein O. Influence of treatment for disruptive behavior disorders on adrenal and gonadal hormones in youth. J Clin Child Adolesc Psychol. 2011;40(4):562-71. doi: 10.1080/15374416.2011.581614.
PubMed 21722028
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Long-Term Outcome in Child Behavior Disorders
- ClinicalTrials.gov ID
- NCT00820001
- Acronym / sponsor ID
- REACH / R01MH057727
- Keywords
- Cognitive Behavioral Therapy, Multimodal Treatment, Physiological Parameters, Hormone Concentration in pubertal development, Treatment as usual comparison
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 254 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Children's Hospital Medical Center, Cincinnati
- Study start
- Dec 2003
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 9 Jan 2009 (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 continuation study evaluates the long-term outcomes of multimodal, modular interventions with early-onset behavior disordered children and innovative methods to promote the maintenance and extension of treatment effects relating to ODD and CD. All participants originally enrolled in the "parent" clinical trial are being followed and those who initially received clinic or community based intervention from a study clinician were randomly assigned to either Booster or No-booster treatment condition. The treatment-as-usual (TAU) and Healthy Control participants were also followed through long-term follow-up assessments paralleling clinically referred participants. The study examines the short and long-term efficacy of booster treatment on clinical outcome, contextual variables, and service satisfaction/use.
Detailed description
Child Conduct problems (CP), as found in Conduct Disorder (CD) and Oppositional Defiant Disorder (ODD), are common and chronic. Although laboratory research studies have yielded promising initial outcomes, follow-up effects are often not studied and, when they are evaluated, are often limited. Maintenance procedures have been generally administered after acute treatment in the form of periodic booster sessions to enhance long-term outcomes (Whisman, 1990). Although the conceptualization and application of maintenance therapies has been described frequently with adults, there is limited information regarding the role of maintenance treatment in child and adolescent psychotherapy (see Eyeberg, 1998). A few studies of booster treatments have reported the return of behavioral improvements (Baer, Williams, Osnes, \& Stokes, 1984; McDonald \& Budd, 1983; Patterson, 1974) and other improvements in conduct-disordered children (Lochman, 1992) and depressed adolescents (Clark et al., 1999), suggesting potential benefits in extending the durability of treatment effects. What is not yet known is the extent to which patients respond positively to a booster (maintenance) treatment condition that is administered after long-term (i.e., three-year) follow-up, one that is designed to reduce recurrence of behavioral dysfunction and the development of new forms of dysfunction during adolescence. The justification for this additional intervention derives from our initial findings and the young age of our sample, which, in most instances, has yet to traverse the period of heightened risk for delinquency.
Literature reviews highlight the importance of addressing at least three primary objectives in understanding the clinical response and long-term adjustment of children with ODD or CD. First, there is a need to document empirically the long-term effects of both specialty treatments and routine services during repeated follow-up assessments in an effort to document the maintenance of all initial treatment gains (Eyberg et al., 1998). Our preliminary findings suggesting the presence of both similarities and differences in the initial outcomes of our two specialty treatments (Community vs. Clinic protocols) supports the conduct of a long-term evaluation in order to determine whether these effects continue or change.
Second, our initial findings underscore the importance of determining the extent to which booster treatment sessions help to promote long-term maintenance or produce long-term preventive effects on some of the more common sequelae of ODD and CD. Booster treatment may be needed to deflect such children from unfolding trajectories toward increased antisocial behavior and multi-system impairments (Loeber et al., 1993). Thus, efforts to promote the long-term outcomes of follow-up in this population must be evaluated in an effort to understand the degree to which they show improvements in serious clinical dysfunction (recovery from Disruptive Behavior Disorders (DBD)) and/or show reductions in the development of new forms of dysfunction (deviant and delinquent activities) that may place these children at-risk for other adverse adolescent outcomes. The young age of this patient sample at the start of this competing continuation(8-16 yrs) may make it easier to demonstrate preventive effects.
Finally, the availability of only modest empirical evidence provides a compelling argument for evaluating potential predictors of each of the above-mentioned long-term follow-up outcomes based on a comprehensive battery of psychosocial (e.g., child, parent, and family adjustment) and biological (e.g., testosterone, cortisol) measures obtained upon study intake and treatment termination. Key predictors of treatment response include lower levels of child, parent, and family dysfunction, barriers to treatment, and SES (Kazdin, 1995; Kazdin \& Wassell, 2000). We will also evaluate the role of contextual or other life changes in understanding treatment effects over the follow up period. Among the important contextual variables to be evaluated include changes in parental and family functioning, peer relationships, and school adjustment. Clearly, these variables may influence continued antisocial behavior at this young age. Thus, we will examine how contextual factors affect how well treatment effects hold as well as the real world impact of treatment on various life changes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Acute Treatment Protocol Booster | Experimental | Behavioral: Booster TreatmentChild participants in this arm were initial participants enrolled in the parent study and randomized to receive the specialty treatment from study clinicians in either the clinic or community setting. In this continuation study, the participants were enrolled at the 36 month assessment and randomized to participate in the booster dose of treatment. The treatment provided in this arm includes specific booster treatment based on the 8 modules of the initial treatment study. Saliva samples were also collected 2 times in the lab and 2 times at home (once at bedtime, once at wake-up time) per initial voluntary saliva protocol at each timepoints to measure endocrine levels. |
| Acute Treatment Protocol No-Booster | Experimental | Behavioral: No-BoosterChild participants in this arm were initial participants enrolled in the parent study and randomized to receive the specialty treatment from study clinicians in either the clinic or community setting. In this continuation study, the participants were enrolled at the 36 month assessment and randomized to participate in assessments only thus not receiving any additional booster treatment. Saliva samples were collected 2 times in the lab and 2 times at home (once at bedtime, once at wake-up time) per initial voluntary saliva protocol at each timepoints to measure endocrine levels. |
| Treatment As Usual | Active comparator | Other: Treatment As UsualChild participants in this arm were initial participants enrolled in the parent study in the clinically referred Treatment As Usual comparison group. These participants were initially enrolled in treatment services with identified providers and received treatment services as provided in that community agency. In this continuation study, the participants were enrolled at the 36 month assessment and participated in the ongoing follow-up assessments only. Saliva samples were collected 2 times in the lab and 2 times at home (once at bedtime, once at wake-up time) per initial voluntary saliva protocol at each timepoints to measure endocrine levels. |
| No Intervention Healthy Comparison | Other | Other: No interventionThe Healthy Control subjects enrolled initially in the parent study are incorporated in a related project designed to evaluate the role of biological measures in differentiating antisocial and normal children. All Healthy Control participants were initially matched to cases in the clinical sample (both the acute treatment and the clinically referred Treatment as Usual). |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- males or females with an age of 6-11 years,
- a DSM-IV diagnosis of CD or ODD,
- residence with at least one parent/guardian;
- intellectual level no less than two SD's below age norms; and
- parent consent for participation.
Key exclusion criteria (4 listed)
- concurrent individual or family participation in a treatment program directed towards the child's disruptive disorders,
- current psychosis, bipolar disorder, or MDD marked by significant vegetative signs,
- suicidality with a plan or homicidality; or
- substance abuse or an eating disorder.
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 |
|---|---|---|
| Booster TreatmentAlso: Modular Cognitive Behavior TherapyBased on this collective evidence, booster treatment was designed to address three general goals: a) clarify key child and parent/family problems and family preferences regarding target problems, b) directly target and resolve these existing problems using the eight domains contained in the existing treatment protocol administered in the initial outcome study, and c) provide the family with clinical recommendations and information to promote the maintenance of skill developments in targeted domains or adaptive routines designed to prevent any further deterioration in clinical functioning. Thus, the clinician may provide a review of prior content or administer new material specifically for older adolescents, as needed, and will attempt to apply these skills to specific problematic situations identified by the family. | Behavioural | Acute Treatment Protocol Booster |
| No-BoosterAlso: No-Booster Comparison conditionAll cases randomized to this condition will simply participate in all of the proposed routine assessments and will receive assessment feedback. Specifically, these families will be provided with a brief summary of the significant clinical findings obtained in their 36-month follow-up assessment (assessment feedback). Such an assessment was provided to clinicians in the original study in order to highlight specific areas in need of clinical attention based on a review of the normative data and clinical cutoffs available for each instrument. Selected information will be conveyed by phone to the participating parent/guardian in a straightforward manner followed by a discussion of some clinical recommendations designed to address these clinical problems. In addition, the parent/guardian will be provided with a listing of professionals who provide services appropriate for this age group and for children with similar problems. | Behavioural | Acute Treatment Protocol No-Booster |
| No interventionAlso: Healthy Control Comparison GroupNo intervention was administered with this arm. Saliva samples were collected 2 times in the lab and 2 times at home (once at bedtime, once at wake-up time) per initial voluntary saliva protocol at each timepoints to measure endocrine levels. | Other | No Intervention Healthy Comparison |
| Treatment As UsualAlso: Treatment As Usual clinical comparison.All cases assigned to this arm simply participated in all of the proposed routine assessments. | Other | Treatment As Usual |
Primary outcome
Individualized child problem targets and externalizing behavior including functional impairment
Time frame: Baseline for continuation (36 months into study participation) and at months 42, 48, 54, 66 (assessment timeline is inclusive of all assessments for parent and continuation trials)
Peer and Family Characteristics
Time frame: Assessed at all follow-up timepoints including baseline (36 month assessment) and all subsequent follow-up assessments at months 42, 48, 54 and 66.
Parental Disfunction
Time frame: Assessed at all timepoints including baseline (36 month) and follow-up assessments at months 42, 48, 54, and 66
2 secondary outcomes
Teacher reports of child functioning
Time frame: Assessed at all timepoints including baseline (36 month) and follow-up assessments at months 42, 48, 54, and 66
Child attentional and internalizing problems
Time frame: Assessed at all timepoints including baseline (36 month) and follow-up assessments at months 42, 48, 54, and 66
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 18 Feb 2013.
- Results publication: PubMed 19221871Kolko DJ, Dorn LD, Bukstein OG, Pardini D, Holden EA, Hart J. Community vs. clinic-based modular treatment of children with early-onset ODD or CD: a clinical trial with 3-year follow-up. J Abnorm Child Psychol. 2009 Jul;37(5):591-609. doi: 10.1007/s10802-009-9303-7.
- Results publication: PubMed 19232020Diler RS, Birmaher B, Axelson D, Goldstein B, Gill M, Strober M, Kolko DJ, Goldstein TR, Hunt J, Yang M, Ryan ND, Iyengar S, Dahl RE, Dorn LD, Keller MB. The Child Behavior Checklist (CBCL) and the CBCL-bipolar phenotype are not useful in diagnosing pediatric bipolar disorder. J Child Adolesc Psychopharmacol. 2009 Feb;19(1):23-30. doi: 10.1089/cap.2008.067.
- Results publication: PubMed 21722028Dorn LD, Kolko DJ, Shenk CE, Susman EJ, Bukstein O. Influence of treatment for disruptive behavior disorders on adrenal and gonadal hormones in youth. J Clin Child Adolesc Psychol. 2011;40(4):562-71. doi: 10.1080/15374416.2011.581614.
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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.
David J Kolko, PhD principal investigator
University of Pittsburgh
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Booster Treatment, No-Booster and Treatment As Usual in people with Oppositional Defiant Disorder and Conduct Disorder, run by University of Pittsburgh at 2 sites 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 5 inclusion and 4 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 18 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Individualized child problem targets and externalizing behavior including functional impairment (time frame: Baseline for continuation (36 months into study participation) and at months 42, 48, 54, 66 (assessment timeline is inclusive of all assessments for parent and continuation trials)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00820001, which also lists 3 linked publications.
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 18 Feb 2013.