Conduct DisorderNCT00612690
School-Based Mental Health Services for Urban Children
A study testing Community mental health consultation model program and Treatment as usual (TAU) in people with Conduct Disorder and Oppositional Defiant Disorder, run by University of Illinois Chicago at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Conduct Disorder, Oppositional Defiant Disorder, Attention Deficit Disorder With Hyperactivity
- What is being tested?
- Community mental health consultation model program and Treatment as usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 482 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to May 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Chicago, Institute for Juvenile Research
Chicago, Illinois, 60608
About this study
Official title: 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.
Read the 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.
- Conditions
- Conduct Disorder, Oppositional Defiant Disorder, Attention Deficit Disorder With Hyperactivity
- Being tested
- Community mental health consultation model program, Treatment as usual (TAU)
- Keywords
- Children, School-Based Mental Health Services, Urban Poverty
- Medical subject headings
- Conduct Disorder, Oppositional Defiant Disorder, Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community mental health consultation model programBehavioural
Also called Links to Learning (L2L)
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.
Treatment as usual (TAU)Behavioural
TAU included referral to community mental health clinic-based services, where participants received standard care for mental health-related problems.
| Study group | Role | What they receive |
|---|---|---|
| Links to Learning | Experimental | Participants received the community mental health consultation model program. Receives: Behavioral: Community mental health consultation model program |
| Services as Usual | Active comparator | Participants received treatment as usual and referrals. Receives: Behavioral: Treatment as usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social Skills Rating System (Parent Report)
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: Measured at pre- and post-school year for 3 years
Secondary outcomes (1)
The Academic Competence Evaluation Scale (ACES)
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: Measured at pre- and post-school year for 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2008 (estimated)
- Study startJun 2005
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Conduct DisorderStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 482 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Marc Atkins, University of Illinois Chicago
- Investigators
- Marc S. Atkins, PhD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00612690
- Sponsor's protocol ID
- R01MH073749
- Other IDs
- R01MH073749, DSIR 82-SECHC
- Status last verified
- May 2014
- First submitted
- 22 Jan 2008
- Last updated
- 4 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Mehta TG, Atkins MS, Frazier SL. The Organizational Health of Urban Elementary Schools: School Health and Teacher Functioning. School Ment Health. 2013 Sep 1;5(3):144-154. doi: 10.1007/s12310-012-9099-4.
PubMed 23935763Neal JW, Neal ZP, Atkins MS, Henry DB, Frazier SL. Channels of change: contrasting network mechanisms in the use of interventions. Am J Community Psychol. 2011 Jun;47(3-4):277-86. doi: 10.1007/s10464-010-9403-0.
PubMed 21181552Neal, JW, Shernoff, ES, Frazier, S.L, Stachowicz, E, Frangos, U, & Atkins, MS (2008). Change from within: Engaging teacher key opinion leaders in the diffusion of interventions in urban schools. The Community Psychologist, 41:2, 53-57
Atkins MS, Frazier SL. Expanding the Toolkit or Changing the Paradigm: Are We Ready for a Public Health Approach to Mental Health? Perspect Psychol Sci. 2011 Sep;6(5):483-7. doi: 10.1177/1745691611416996.
PubMed 26168200Atkins MS, Hoagwood KE, Kutash K, Seidman E. Toward the integration of education and mental health in schools. Adm Policy Ment Health. 2010 Mar;37(1-2):40-7. doi: 10.1007/s10488-010-0299-7.
PubMed 20309623
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mental Health Services & Predictors of Learning in Urban Schools
- ClinicalTrials.gov ID
- NCT00612690
- Acronym / sponsor ID
- R01MH073749
- Conditions
- Conduct Disorder, Oppositional Defiant Disorder, Attention Deficit Disorder With Hyperactivity
- Keywords
- Children, School-Based Mental Health Services, Urban Poverty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 482 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jun 2005
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 12 Feb 2008 (estimated)
- Results
- Posted 4 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Links to Learning | Experimental | Behavioral: Community mental health consultation model programParticipants received the community mental health consultation model program. |
| Services as Usual | Active comparator | Behavioral: Treatment as usual (TAU)Participants received treatment as usual and referrals. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Community mental health consultation model programAlso: Links to Learning (L2L)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. | Behavioural | Links to Learning |
| Treatment as usual (TAU)TAU included referral to community mental health clinic-based services, where participants received standard care for mental health-related problems. | Behavioural | Services as Usual |
Primary outcome
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.
1 secondary outcome
The Academic Competence Evaluation Scale (ACES)
Time frame: Measured at pre- and post-school year for 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23935763Mehta TG, Atkins MS, Frazier SL. The Organizational Health of Urban Elementary Schools: School Health and Teacher Functioning. School Ment Health. 2013 Sep 1;5(3):144-154. doi: 10.1007/s12310-012-9099-4.
- Background: PubMed 21181552Neal JW, Neal ZP, Atkins MS, Henry DB, Frazier SL. Channels of change: contrasting network mechanisms in the use of interventions. Am J Community Psychol. 2011 Jun;47(3-4):277-86. doi: 10.1007/s10464-010-9403-0.
- BackgroundNeal, JW, Shernoff, ES, Frazier, S.L, Stachowicz, E, Frangos, U, & Atkins, MS (2008). Change from within: Engaging teacher key opinion leaders in the diffusion of interventions in urban schools. The Community Psychologist, 41:2, 53-57
- Background: PubMed 26168200Atkins MS, Frazier SL. Expanding the Toolkit or Changing the Paradigm: Are We Ready for a Public Health Approach to Mental Health? Perspect Psychol Sci. 2011 Sep;6(5):483-7. doi: 10.1177/1745691611416996.
- Background: PubMed 20309623Atkins MS, Hoagwood KE, Kutash K, Seidman E. Toward the integration of education and mental health in schools. Adm Policy Ment Health. 2010 Mar;37(1-2):40-7. doi: 10.1007/s10488-010-0299-7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc S. Atkins, PhD principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community mental health consultation model program and Treatment as usual (TAU) in people with Conduct Disorder and Oppositional Defiant Disorder, run by University of Illinois Chicago 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 3 inclusion and 2 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 4 Jun 2014. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Social Skills Rating System (Parent Report) (time frame: Measured at pre- and post-school year for 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00612690, which also lists 5 linked publications.
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 4 Jun 2014.