Resources to Enhance the Adjustment of Children (REACH)

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Brief Title

Resources to Enhance the Adjustment of Children (REACH)

Official Title

Enhancing Long-Term Outcome in Child Behavior Disorders

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.
    


Study Type

Interventional


Primary Outcome

Individualized child problem targets and externalizing behavior including functional impairment

Secondary Outcome

 Teacher reports of child functioning

Condition

Oppositional Defiant Disorder

Intervention

Booster Treatment

Study Arms / Comparison Groups

 Acute Treatment Protocol Booster
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Behavioral

Estimated Enrollment

254

Start Date

December 2003

Completion Date

November 2009

Primary Completion Date

November 2009

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.
      

Gender

All

Ages

6 Years - 11 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

David J Kolko, PhD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00820001

Organization ID

R01MH057727


Responsible Party

Principal Investigator

Study Sponsor

University of Pittsburgh

Collaborators

 Children's Hospital Medical Center, Cincinnati

Study Sponsor

David J Kolko, PhD, Principal Investigator, University of Pittsburgh


Verification Date

February 2013