Resources to Enhance the Adjustment of Children (REACH)
REACH
Enhancing Long-Term Outcome in Child Behavior Disorders
1 other identifier
interventional
254
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2003
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2003
CompletedFirst Submitted
Initial submission to the registry
January 7, 2009
CompletedFirst Posted
Study publicly available on registry
January 9, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedFebruary 18, 2013
February 1, 2013
5.9 years
January 7, 2009
February 15, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Individualized child problem targets and externalizing behavior including functional impairment
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
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
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
Assessed at all timepoints including baseline (36 month) and follow-up assessments at months 42, 48, 54, and 66
Child attentional and internalizing problems
Assessed at all timepoints including baseline (36 month) and follow-up assessments at months 42, 48, 54, and 66
Study Arms (4)
Acute Treatment Protocol Booster
EXPERIMENTALChild 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
EXPERIMENTALChild 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 COMPARATORChild 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
OTHERThe 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).
Interventions
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.
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 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.
All cases assigned to this arm simply participated in all of the proposed routine assessments.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Bellefield Towers - Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, 15213, United States
Related Publications (3)
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.
PMID: 19221871RESULTDiler 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.
PMID: 19232020RESULTDorn 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.
PMID: 21722028RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David J Kolko, PhD
University of Pittsburgh
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Psychiatry, Psychology, and Pediatrics
Study Record Dates
First Submitted
January 7, 2009
First Posted
January 9, 2009
Study Start
December 1, 2003
Primary Completion
November 1, 2009
Study Completion
November 1, 2009
Last Updated
February 18, 2013
Record last verified: 2013-02