School-Based Mental Health Services for Urban Children

May 15, 2014 updated by: Marc Atkins, University of Illinois at Chicago

Mental Health Services & Predictors of Learning in Urban Schools

This study will evaluate the effectiveness of school- and home-based mental health services and training modules in supporting learning and behavior in financially disadvantaged children who live in urban areas.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

There are an estimated 4.5 to 6.3 million children with mental disorders in the United States. Emotional and behavioral problems associated with childhood mental disorders have a significant impact, with affected children at an increased risk of reduced quality of life and school dropout. If left untreated, childhood mental disorders may continue into adulthood, often impairing ability to function as an adult. It is believed that, compared to clinic-based services, school- and home-based mental health services may lead to greater improvements in children's learning and behavior at school and home. Especially important to this type of approach is a collaborative effort among parents, teachers, and children to encourage and maintain positive behaviors and academic performance both at home and in the classroom. This study evaluated the effectiveness of school- and home-based mental health services and training modules in supporting learning and behavior in financially disadvantaged children who live in urban areas.

This 3-year study involved parent, child, and teacher participants. During Year 1, teacher participants attended a professional development series that focused on strategies that classroom teachers can use to help children with learning and behavior problems at school. The series involved weekly 30-minute sessions, which were held before and after school hours, for a total of 6 months. Teachers completed a brief survey about the content and structure of sessions at the end of each session and gave a monthly review on how they applied their new strategies in the classroom setting. Teachers continued to attend booster sessions of up to 1 hour each month during Year 2. Teachers also participated in periodic case consultation meetings with parents and mental health providers to further develop ways to improve student participants' learning and behavior.

Child participants received either the community mental health program associated with their school or received general clinic-based services (Treatment as usual). The school component of the mental health program consisted of a classroom environment in which the teachers implemented their newly learned strategies to enhance the academic and behavioral performance of the child participants. Parents of child participants in the community mental health program were invited to attend a series of parent/teacher meetings and home visits where mental health service providers discussed strategies that parents and teachers can use to help improve their children's learning and behavior. Parents completed a brief questionnaire at the end of each meeting and gave a monthly review of how they implemented their new strategies in the home setting. Parents continued to communicate with research staff regarding services provided throughout the study.

Assessments for all participants occurred five times over 3 years. Assessments for parent participants included questions about their child's behavior at school and home, their child's use of mental health services, involvement in their child's schooling, and possible stresses in life. Assessments for teachers included questions about the behavior and academic performances of the child participants, parent involvement with the children's schooling, and stresses in their work environment. A research staff member also conducted a 2-hour classroom observation five times over 3 years. Individual child participants were also observed in the classroom by research staff for three 15-minute intervals five times over the study period.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
482

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60608
        • University of Illinois at Chicago, Institute for Juvenile Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

5 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Student in kindergarten through 4th grade in a participating school
  • Diagnosis of conduct disorder, oppositional defiant disorder, or attention deficit hyperactivity disorder as confirmed by parent and/or teacher report
  • Parents and teachers of these students were also eligible to participate

Exclusion Criteria:

  • Severe developmental or medical disability

Note: Teachers, parents, and mental health providers of the children enrolled in the study were also consented as per directions from our Institutional Review Board (IRB) because we were asking about sensitive information. Therefore, the ages listed below are for the children enrolled in the study as this was the determining criteria for study participation. Ages of participating adults (i.e., parents and teachers) were included in Baseline Characteristics to provide a complete description of the study participants. However, although adults participated in the study, the eligibility criteria were based on child characteristics as noted above.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Links to Learning
Participants received the community mental health consultation model program.
Behavioral: Community mental health consultation model program
The community mental health consultation model program included collaboration among community mental health providers and (1) parent advocates to effectively maintain families in a school-based mental health program, (2) classroom teachers to enhance children's academic performance, and (3) peer-identified influential teachers to influence classroom teachers' use of behavior management strategies. This model further focused on the strongest teacher and parent predictors of student learning.
Other Names:
  • Links to Learning (L2L)
Active Comparator: Services as Usual
Participants received treatment as usual and referrals.
Behavioral: Treatment as usual (TAU)
TAU included referral to community mental health clinic-based services, where participants received standard care for mental health-related problems.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Social Skills Rating System (Parent Report)
Time Frame: Measured at pre- and post-school year for 3 years
This rating scale was completed by parents to assess how frequently their child engaged in a range of disruptive, prosocial, and academic behaviors (0 = Never to 2 = Very Often). Normative data are provided by age and sex and the measure was standardized on a heterogeneous population of which one third were urban and 28% were minorities. The scale score, Social Skills, was the primary outcome measure. Scores are rated on a scale of 0 (Never) to 2 (Very Often). The scale score, Social Skills, containing 38 items, was the primary outcome measure. Scores range from 0 to 76 with higher scores indicating improved social skills.
Measured at pre- and post-school year for 3 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The Academic Competence Evaluation Scale (ACES)
Time Frame: Measured at pre- and post-school year for 3 years
The ACES is a teacher rating scale that describes a set of behaviors and attitudes measuring teachers' perceptions of student's academic competence and performance. The scale consists of 30 items rated on a 5-point scale (1 = Never, 2 = Seldom, 3 = Sometimes, 4 = Often, 5 = Almost Always). The total score was reported as a mean per item with higher scores indicating better academic competence. Scores could range from 1 to 30.
Measured at pre- and post-school year for 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Illinois at Chicago

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marc S. Atkins, PhD, University of Illinois at Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2005

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 22, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 12, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 4, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R01MH073749 (U.S. NIH Grant/Contract)
  • DSIR 82-SECHC (Other Grant/Funding Number: NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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