Clinical trial NCT00820001: Resources to Enhance the Adjustment of Children (REACH)
Official title: Enhancing Long-Term Outcome in Child Behavior Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oppositional Defiant Disorder
Conduct Disorder
Attention Deficit Hyperactivity Disorder
Keywords: Cognitive Behavioral Therapy
Multimodal Treatment
Physiological Parameters
Hormone Concentration in pubertal development
Treatment as usual comparison
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Children's Hospital Medical Center, Cincinnati
First posted: 2009-01-09
Enrollment: 254
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: All participants were enrolled in the initial "parent" study and criteria for initial enrollment included:

Inclusion Criteria:

1. males or females with an age of 6-11 years,
2. a DSM-IV diagnosis of CD or ODD,
3. residence with at least one parent/guardian;
4. intellectual level no less than two SD's below age norms; and
5. parent consent for participation.

Exclusion Criteria:

1. concurrent individual or family participation in a treatment program directed towards the child's disruptive disorders,
2. current psychosis, bipolar disorder, or MDD marked by significant vegetative signs,
3. suicidality with a plan or homicidality; or
4. substance abuse or an eating disorder.

Primary outcomes:
measure: Individualized child problem targets and externalizing behavior including functional impairment
timeFrame: 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)
measure: Peer and Family Characteristics
timeFrame: Assessed at all follow-up timepoints including baseline (36 month assessment) and all subsequent follow-up assessments at months 42, 48, 54 and 66.
measure: Parental Disfunction
timeFrame: Assessed at all timepoints including baseline (36 month) and follow-up assessments at months 42, 48, 54, and 66
Secondary outcomes:
measure: Teacher reports of child functioning
timeFrame: Assessed at all timepoints including baseline (36 month) and follow-up assessments at months 42, 48, 54, and 66
measure: Child attentional and internalizing problems
timeFrame: Assessed at all timepoints including baseline (36 month) and follow-up assessments at months 42, 48, 54, and 66
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Pittsburgh
country: United States
facility: Bellefield Towers - Western Psychiatric Institute and Clinic
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: David J Kolko, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Dorn 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.