- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00820001
Resources to Enhance the Adjustment of Children (REACH) (REACH)
Enhancing Long-Term Outcome in Child Behavior Disorders
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ohio
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Cincinnati, Ohio, United States, 45229
- Cincinnati Children's Hospital Medical Center
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- Bellefield Towers - Western Psychiatric Institute and Clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
All participants were enrolled in the initial "parent" study and criteria for initial enrollment included:
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Acute Treatment Protocol Booster
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.
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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.
Other Names:
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EXPERIMENTAL: Acute Treatment Protocol No-Booster
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.
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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.
Other Names:
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ACTIVE_COMPARATOR: Treatment As Usual
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.
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All cases assigned to this arm simply participated in all of the proposed routine assessments.
Other Names:
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OTHER: No Intervention Healthy Comparison
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).
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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)
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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)
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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.
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Assessed at all follow-up timepoints including baseline (36 month assessment) and all subsequent follow-up assessments at months 42, 48, 54 and 66.
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Parental Disfunction
Time Frame: Assessed at all timepoints including baseline (36 month) and follow-up assessments at months 42, 48, 54, and 66
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Assessed at all timepoints including baseline (36 month) and follow-up assessments at months 42, 48, 54, and 66
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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Assessed at all timepoints including baseline (36 month) and follow-up assessments at months 42, 48, 54, and 66
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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
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Assessed at all timepoints including baseline (36 month) and follow-up assessments at months 42, 48, 54, and 66
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General 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.
- Diler 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.
- Shenk, C. E., Dorn, L. D. Susman, E. J., Kolko, D. & Noll, J. G. (under review). Influence of Adrenal and Gonadal Hormones on Treatment Response for Children with Disruptive Behavior Disorders.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01MH057727 (NIH)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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