Middle School Matters Study (MSM)
This study is ongoing, but not recruiting participants.
Sponsor:
Seattle Children's Hospital
Collaborator:
Information provided by (Responsible Party):
Carolyn McCarty, Seattle Children's Hospital
ClinicalTrials.gov Identifier:
NCT01220635
First received: October 5, 2010
Last updated: April 25, 2012
Last verified: April 2012
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Purpose
This study aims to evaluate the short-term and long-term efficacy of two preventative intervention approaches designed to support middle school youth.
| Condition | Intervention |
|---|---|
|
Depression |
Behavioral: Positive Thoughts and Actions Program Behavioral: Individual Support Program |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Prevention of Depression Within Salient Adolescent Contexts |
Resource links provided by NLM:
Further study details as provided by Seattle Children's Hospital:
Primary Outcome Measures:
- Moods and Feelings Questionnaire (MFQ; child and parent version) [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]Depressive symptoms of the child are assessed on the MFQ. Youth will complete the MFQ at all 4 timepoints, parent ratings of students symptoms will be collected at baseline, post-intervention, and 12 month follow up.
Secondary Outcome Measures:
- Parent-Child Communication (PCC; child and parent version) [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]Parent child communication will be assessed using the child and parent version of the PCC. Children will complete the PCC at all 4 timepoints, parent ratings will be collected at baseline, post-intervention, and 12 month follow up.
- Behavioral Assessment System for Children-2nd Edition (BASC-2; student, parent, & teacher version) [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]The adolescent version of the Teacher Rating Scale, Parent Rating Scale, and the Student Self-Report of Personality of the BASC-2 will be used to assess school functioning and social functioning.
- Health Enhancing Behavior Index (HEBI) [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]Health behaviors (diet, exercise, and sleep) are self-reported by the youth on the HEBI.
- Service Use Interview (Service for Children and Adolescence Parent Interview-modified) [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]The service use interview will be used to measure treatment history and services received during the course of the intervention and follow up. The service use interview will typically be conducted with the participating parents. If a parent is unable to complete an interview, then the service use interview will be conducted with the youth.
- Schedule for Affective Disorders and Schizophrenia for School-Age Children (KSADS) [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]The depression module of the KSADS will be used to assess DSM-IV symtpoms of major depression and depressive disoder at the 12-month follow up.
| Estimated Enrollment: | 160 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | August 2012 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Skill Group Program
Positive Thoughts and Actions Program
|
Behavioral: Positive Thoughts and Actions Program
Students in the skills group will attend a 12-session (50 minutes each), 12-week program with 4-6 other students. The skills group will take place at school during school hours. Parents in the skill group will be asked to participate in two parent group workshops to take place at their child's school or other participating middle school (2-hours each). In addition, the skill group leader will conduct two individual family meetings with the student and parent(50 minutes each).
|
|
Active Comparator: Individual Support Program
Measure of Adolescent Potential for Suicide (MAPS) - modified
|
Behavioral: Individual Support Program
Students will be individually interviewed (60-90 minutes) at school to review areas of stress and support. The health professional conducting the interview will reinforce the student's strengths, and provide connections to sources of help from caring adults at home and at school. Parents will be called following the assessment to help the family locate appropriate resources if needed (e.g., tutoring resources, school counselor).
|
Detailed Description:
This study involve two parts: Part 1 will entail screening 7th and 8th graders from 4 public middle schools to identify students who may be showing moderate signs of stress. Students who score at the designated cutoff on a depression symptoms measure will receive a brief check-in to determine eligibility for the follow up randomized trial (Part 2). An "indicated" sample of 160 adolescents in the 7th and 8th grade and their caregivers will be randomly assigned to a brief, Individual Support Program (ISP) comparison group (n = 80) or a Skills Group Program (n = 80). Research interviews will be conducted at multiple timepoints with students and caregivers, and teacher questionnaires will be used to examine changes in outcome measures. Following completion of the intervention, all participants will be followed for 12-months.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 7th and 8th grade students at 4 participating middle schools
- Score 14 or above on the Mood and Feelings Questionnaire at screening (approximately top 25%)
- No imminent plans to move or change to non-participating school
- At minimum 6th grade language skills
- Agree to participate in random assignment and research interviews
- One Parent/caregiver willing to complete research interviews
Exclusion Criteria:
- Student with past or current Major Depressive Disorder (MDD) or Probable MDD
- Students with parents who do not speak English or Spanish
- Students in concurrent treatment
- Students in self-contained classroom, or with cognitive delays, or emotional behavioral problems that would preclude them from benefiting from the group or being a good group member
- Parent not willing to complete research interviews
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01220635
Locations
| United States, Washington | |
| Seattle Children's | |
| Seattle, Washington, United States, 98115 | |
Sponsors and Collaborators
Seattle Children's Hospital
Investigators
| Principal Investigator: | Carolyn A McCarty, Ph.D. | Seattle Children's Research Institute |
More Information
No publications provided
| Responsible Party: | Carolyn McCarty, Principal Investigator, Seattle Children's Hospital |
| ClinicalTrials.gov Identifier: | NCT01220635 History of Changes |
| Other Study ID Numbers: | R34 MH083706, 5R34MH083076-03 |
| Study First Received: | October 5, 2010 |
| Last Updated: | April 25, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Seattle Children's Hospital:
|
Depressive Symptoms Depression prevention Adolescents School-Based Services Health Behavior |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Behavioral Symptoms Mood Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 16, 2013