School-Based Mental Health Services for Urban Children

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Marc Atkins, University of Illinois at Chicago
ClinicalTrials.gov Identifier:
NCT00612690
First received: January 22, 2008
Last updated: May 15, 2014
Last verified: May 2014
Results First Received: August 16, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Health Services Research
Conditions: Conduct Disorder
Oppositional Defiant Disorder
Attention Deficit Disorder With Hyperactivity
Interventions: Behavioral: Community mental health consultation model program
Behavioral: Treatment as usual (TAU)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Links to Learning

Participants underwent the community mental health consultation model program.

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.

Services as Usual

Participants received treatment as usual and referrals.

Treatment as usual (TAU) : TAU included referral to community mental health clinic-based services, where participants received standard care for mental health-related problems.


Participant Flow:   Overall Study
    Links to Learning     Services as Usual  
STARTED     275     207  
COMPLETED     160     89  
NOT COMPLETED     115     118  
Lost to Follow-up                 72                 98  
Withdrawal by Subject                 32                 20  
Withdrawal by Site                 11                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Total number of students, teachers, parents, and service providers (in the Links to Learn condition only) who were consented to participate in the study (Note: Service providers in the Services as Usual condition were not research participants).

Reporting Groups
  Description
Links to Learning Mental health intervention focused on enhancing the predictors of young children's school success
Services As Usual Referral to nearby community mental heath agencies for clinic-based services where participants received standard care for mental health-related problems.
Total Total of all reporting groups

Baseline Measures
    Links to Learning     Services As Usual     Total  
Number of Participants  
[units: participants]
  289     193     482  
Age  
[units: participants]
     
<=18 years     104     67     171  
Between 18 and 65 years     185     126     311  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
     
Students     7.42  ± 1.81     7.66  ± 1.53     7.51  ± 1.71  
Teachers     41.44  ± 13.46     35.58  ± 11.46     38.37  ± 12.73  
Service Providers     32.46  ± 8.73     NA  ± NA [1]   32.46  ± 8.73  
Parents     32.06  ± 7.92     32.64  ± 8.44     32.28  ± 8.10  
Gender, Customized  
[units: participants]
     
Students: Male     74     50     124  
Students: Female     30     17     47  
Teachers: Male     9     7     16  
Teachers: Female     62     58     120  
Service Provders: Male     4     NA [1]   NA [2]
Service Providers: Female     13     NA [1]   NA [2]
Parents: Male     1     6     7  
Parents: Female     96     55     151  
Gender  
[units: participants]
     
Female     201     130     331  
Male     88     63     151  
Region of Enrollment  
[units: participants]
     
United States     289     193     482  
[1] Service providers in this condition were not research participants.
[2] Total not calculated because data are not available (NA) in one or more arms.



  Outcome Measures
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1.  Primary:   Social Skills Rating System (Parent Report)   [ Time Frame: Measured at pre- and post-school year for 3 years ]

2.  Secondary:   The Academic Competence Evaluation Scale (ACES)   [ Time Frame: Measured at pre- and post-school year for 3 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
This study was conducted in high poverty urban communities and therefore there were many impediments to recruitment and retention such as school closings and family migration.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Marc S. Atkins, Ph.D.
Organization: University of Illinois at Chicago
phone: 312-413-1048
e-mail: atkins@uic.edu


Publications:

Responsible Party: Marc Atkins, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT00612690     History of Changes
Other Study ID Numbers: R01 MH073749, R01MH073749, DSIR 82-SECHC
Study First Received: January 22, 2008
Results First Received: August 16, 2013
Last Updated: May 15, 2014
Health Authority: United States: Federal Government