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School-Based Mental Health Services for Urban Children

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
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;   Intervention Model: Parallel Assignment;   Masking: Single (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 
Overall Participants Analyzed 
[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 [1] 
[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 [1]   32.46  (8.73) 
Parents   32.06  (7.92)   32.64  (8.44)   32.28  (8.10) 
[1] Service providers in this condition were not research participants.
Gender, Customized [1] [2] 
[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 
[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.
Gender 
[Units: Participants]
     
Female   201   130   331 
Male   88   63   151 
Region of Enrollment 
[Units: Participants]
     
United States   289   193   482 


  Outcome Measures
  Show All Outcome Measures

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: R01MH073749 ( U.S. NIH Grant/Contract )
DSIR 82-SECHC ( Other Grant/Funding Number: NIH )
Study First Received: January 22, 2008
Results First Received: August 16, 2013
Last Updated: May 15, 2014