Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00612690
Other study ID # R01MH073749
Secondary ID R01MH073749DSIR
Status Completed
Phase N/A
First received January 22, 2008
Last updated May 15, 2014
Start date June 2005
Est. completion date May 2010

Study information

Verified date May 2014
Source University of Illinois at Chicago
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 482
Est. completion date May 2010
Est. primary completion date May 2010
Accepts healthy volunteers No
Gender Both
Age group 5 Years to 12 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States University of Illinois at Chicago, Institute for Juvenile Research Chicago Illinois

Sponsors (2)

Lead Sponsor Collaborator
University of Illinois at Chicago National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

Atkins 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. — View Citation

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. — View Citation

Neal 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. — View Citation

Neal, 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

Outcome

Type Measure Description Time frame Safety issue
Primary 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 at pre- and post-school year for 3 years No
Secondary 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 at pre- and post-school year for 3 years No
See also
  Status Clinical Trial Phase
Completed NCT00202605 - Safety and Efficacy of SPD465 in Adults With ADHD Phase 2
Not yet recruiting NCT02677519 - A 12-Month Open Label Safety Study of Aptensio XR® in Children Ages 4-5 Years Diagnosed With ADHD Phase 4
Completed NCT02730572 - Concerta (Methylphenidate) -To-Generic Switch Study N/A
Completed NCT01681082 - Psychological Effects of Tai Chi Training N/A
Active, not recruiting NCT01330693 - Cortical Excitability: Phenotype and Biomarker in Attention-deficit, Hyperactivity Disorder (ADHD) Therapy Phase 3
Completed NCT00830700 - Children's Attention Deficit Disorder With Hyperactivity (ADHD) Telemental Health Treatment Study N/A
Completed NCT01012622 - An Efficacy and Safety Study of Osmotic Release Oral System (OROS) Methylphenidate in Participants With Attention Deficit Hyperactivity Disorder (ADHD) Phase 4
Completed NCT00626236 - Phase 2a Study of Safety and Tolerability of SPN-810 in Children With ADHD and Persistent Serious Conduct Problems Phase 2
Completed NCT00598182 - Adherence and Long-term Effect of OROS Methylphenidate (CONCERTA): A Follow-up Study N/A
Completed NCT00381407 - Organizational Skills Training for Children With Attention Deficit Hyperactivity Disorder N/A
Completed NCT00178503 - Methylphenidate for Attention Deficit Hyperactivity Disorder and Autism in Children Phase 2/Phase 3
Completed NCT00247572 - Safety, Tolerability and Abuse Liability Study of Intravenous NRP104 in Adults With Stimulant Abuse Histories Phase 2
Completed NCT00118911 - Cognitive Behavioral Therapy for Treatment of Adult Attention Deficit Hyperactivity Disorder N/A
Completed NCT00218322 - Effectiveness of ATMX in Treating Adolescents With ADHD and SUD Phase 4
Completed NCT00557011 - NRP104, Adderall XR or Placebo in Children Aged 6-12 Years With ADHD Phase 2
Completed NCT00071656 - Psychosocial Treatment for Attention Deficit Hyperactivity Disorder (ADHD) Type I N/A
Active, not recruiting NCT00057668 - Preventing Behavior Problems in Children With ADHD Phase 2
Completed NCT00050622 - Behavioral Treatment, Drug Treatment, and Combined Treatment for Attention Deficit Hyperactivity Disorder (ADHD) N/A
Completed NCT00050050 - Cognitive Behavioral Therapy for Adult Attention Deficit Hyperactivity Disorder Phase 1
Completed NCT00031395 - Clonidine in Attention Deficit Hyperactivity Disorder (ADHD) in Children Phase 3