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Behavioral ProblemsPhase 2NCT01488292

RECAP Multi-Component Intervention Program

A Phase 2 study testing RECAP social skills and reading program in people with Behavioral Problems and Emotional Problems, run by Vanderbilt University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 6 to 15 years
Conditions the study is for
Behavioral Problems, Emotional Problems
What is being tested?
RECAP social skills and reading program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteUnited States
Study dates
Aug 2009to Jun 2015
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 15 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Enrollment in behavioral classroom

Who cannot join

  • Lack of legal guardian to provide consent

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Vanderbilt University

    Nashville, Tennessee, 37212

Other trials in United States

About this study

Official title: Multi-Component Mental Health & Academic Intervention for Student Reintegration

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.

Read the detailed 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.

Being tested
RECAP social skills and reading program
Keywords
mental health, social skills
Medical subject headings
Problem Behavior, Psychological Well-Being, Social Skills

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RECAP social skills and reading programBehavioural

    weekly individual and group sessions

Study groups in NCT01488292
Study groupRoleWhat they receive
RECAP social skills and reading programExperimentalNot described
Receives: Behavioral: RECAP social skills and reading program
Control group (services as usual)No interventionControl Group (services as usual)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in child emotional and behavioral problems

    Teacher TRF, Parent CBCL, Student SBQ ratings

    Measured: Baseline & 18 months

  2. Change in Woodcock Reading Mastery Test

    Measured: Baseline & 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2011 (estimated)
  2. Study startAug 2009
  3. Primary completionJun 2014
  4. Study completionJun 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01488292
Sponsor's protocol ID
090633
Other IDs
R01MH077596
Status last verified
Dec 2014
First submitted
23 Nov 2011
Last updated
8 Jun 2015
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing RECAP social skills and reading program in people with Behavioral Problems and Emotional Problems, run by Vanderbilt University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in child emotional and behavioral problems (time frame: Baseline & 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2015.

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