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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01488292
Other study ID # 090633
Secondary ID R01MH077596
Status Completed
Phase Phase 2
First received November 23, 2011
Last updated June 4, 2015
Start date August 2009
Est. completion date June 2015

Study information

Verified date December 2014
Source Vanderbilt University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review BoardUnited States: Federal Government
Study type Interventional

Clinical Trial Summary

This study evaluates the efficacy of the RECAP Mental Health + Academic Program for special education students in behavioral classrooms. The program includes multiple service components: the RECAP classroom mental health curriculum, which develops students' behavioral and social skills; reading intervention; individualized skills training; and parent group. Schools are randomly assigned to the treatment or control group. This two-year multi-component mental health and academic intervention is hypothesized to improve students' mental health, social skills, and academic functioning.


Description:

Background Information

This research project evaluates the efficacy of the RECAP Mental Health + Academic Program, a two-year multi-component intervention for special education students in behavioral classrooms. The program has been shown to reduce students' emotional and behavioral problems and remediate academic deficits, particularly with regard to reading skills, in order to enhance academic and behavioral functioning and to facilitate special education students' appropriate transition and reintegration into the mainstream educational setting.

Using an educational and instructional approach that is familiar to school staff and students, RECAP helps teachers and parents to assist children in the development of behavioral and emotional skills that facilitate children's ability to learn and to solve problems adaptively. Many of the techniques and strategies used in RECAP are familiar to teachers, as RECAP represents an integration of basic behavioral principles. Its unique strength lies in its consistent and integrated framework, which provides a common language for students, teachers, and parents to talk about behavioral expectations and positive skills for children to learn and apply in everyday situations. Moreover, the RECAP program focuses on helping students resolve the behavioral and emotional problems that interfere with their own learning as well as the learning of other students in the classroom (e.g., due to lost instructional time via classroom disruption). In addition to this mental health curriculum, the intervention includes a reading intervention component that has been shown to significantly improve the academic progress of students with emotional and behavioral problems. In addition to the obvious fundamental need for direct remediation of this academic skills deficit that is common among these students, the reading intervention is designed to prepare special education students to participate in the academic instruction of the general education classroom at a functionally adaptive level.

Participating schools are randomly assigned to either receive the RECAP program or serve as a comparison school (services as usual). Student outcomes will be evaluated in the fall and spring of two school years, using behavioral observation, academic testing, and teacher-, parent-, and child-reports of psychopathology and social skills.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date June 2015
Est. primary completion date June 2014
Accepts healthy volunteers No
Gender Both
Age group 6 Years to 15 Years
Eligibility Inclusion Criteria:

- Enrollment in behavioral classroom

Exclusion Criteria:

- Lack of legal guardian to provide consent

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
RECAP social skills and reading program
weekly individual and group sessions

Locations

Country Name City State
United States Vanderbilt University Nashville Tennessee

Sponsors (2)

Lead Sponsor Collaborator
Vanderbilt University National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in child emotional and behavioral problems Teacher TRF, Parent CBCL, Student SBQ ratings Baseline & 18 months No
Primary Change in Woodcock Reading Mastery Test Baseline & 18 months No
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