NCT01488292

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2009

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

November 23, 2011

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 8, 2011

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

June 8, 2015

Status Verified

December 1, 2014

Enrollment Period

4.8 years

First QC Date

November 23, 2011

Last Update Submit

June 4, 2015

Conditions

Behavioral ProblemsEmotional Problems

Keywords

mental healthsocial skills

Outcome Measures

Primary Outcomes (2)

  • Change in child emotional and behavioral problems

    Teacher TRF, Parent CBCL, Student SBQ ratings

    Baseline & 18 months

  • Change in Woodcock Reading Mastery Test

    Baseline & 18 months

Study Arms (2)

RECAP social skills and reading program

EXPERIMENTAL
Behavioral: RECAP social skills and reading program

Control group (services as usual)

NO INTERVENTION

Control Group (services as usual)

Interventions

RECAP social skills and reading programBEHAVIORAL

weekly individual and group sessions

RECAP social skills and reading program

Eligibility Criteria

Age6 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Enrollment in behavioral classroom

You may not qualify if:

  • Lack of legal guardian to provide consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37212, United States

Location

MeSH Terms

Conditions

Problem BehaviorPsychological Well-BeingSocial Skills

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorChild BehaviorPersonal SatisfactionSocial Behavior

Study Officials

  • Susan S Han, PhD

    Vanderbilt University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 23, 2011

First Posted

December 8, 2011

Study Start

August 1, 2009

Primary Completion

June 1, 2014

Study Completion

June 1, 2015

Last Updated

June 8, 2015

Record last verified: 2014-12

Locations

US(1)