Middle School Matters Study (MSM)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Carolyn McCarty, Seattle Children's Hospital
ClinicalTrials.gov Identifier:
NCT01220635
First received: October 5, 2010
Last updated: February 13, 2014
Last verified: February 2014
  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

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 completed the MFQ at all 4 timepoints, parent ratings of students symptoms were 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 were assessed using the child and parent version of the PCC. Children completed the PCC at all 4 timepoints, parent ratings were 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 were 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 was used to measure treatment history and services received during the course of the intervention and follow up.

  • 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 was used to assess DSM-IV symptoms of major depression and depressive disorder at the 12-month follow up.


Enrollment: 120
Study Start Date: October 2010
Study Completion Date: October 2012
Primary Completion Date: October 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 entailed 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 received a brief check-in to determine eligibility for the follow up randomized trial (Part 2). An "indicated" sample of 120 adolescents in the 7th and 8th grade and their caregivers were randomly assigned to a brief, Individual Support Program (ISP) comparison group or a Skills Group Program. Research interviews were conducted at multiple timepoints with students and caregivers, and teacher questionnaires were used to examine changes in outcome measures. Following completion of the intervention, all participants were 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: February 13, 2014
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
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on October 20, 2014