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CompletedNCT01220635MSMUpdated Feb 14, 2014

Middle School Matters Study

An interventional study of Positive Thoughts and Actions Program and Individual Support Program in Depression, sponsored by Seattle Children's Hospital. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2014-02-14.

Sponsored by Seattle Children's Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Sex
All
01

Study summary

This study aims to evaluate the short-term and long-term efficacy of two preventative intervention approaches designed to support middle school youth.

Read the 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.

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Conditions studied

  • Depression

Keywords

  • Depressive Symptoms
  • Depression prevention
  • Adolescents
  • School-Based Services
  • Health Behavior
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In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's enrollment of 120 is above the median of 84 across 6,720 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Seattle Children's Hospital is the lead sponsor of 210 studies on the registry; 43 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
120 participants (actual)

Study arms

  • Experimental
    Skill Group Program

    Positive Thoughts and Actions Program

    Behavioral: Positive Thoughts and Actions Program

  • Active comparator
    Individual Support Program

    Measure of Adolescent Potential for Suicide (MAPS) - modified

    Behavioral: Individual Support Program

Interventions

  • BehavioralPositive 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).

  • BehavioralIndividual 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).

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What researchers measure

Primary outcomes

  1. Moods and Feelings Questionnaire (MFQ; child and parent version)

    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.

    Time frame: up to 1 year

Secondary outcomes

  1. Parent-Child Communication (PCC; child and parent version)

    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.

    Time frame: up to 1 year

  2. Behavioral Assessment System for Children-2nd Edition (BASC-2; student, parent, & teacher version)

    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.

    Time frame: up to 1 year

  3. Health Enhancing Behavior Index (HEBI)

    Health behaviors (diet, exercise, and sleep) are self-reported by the youth on the HEBI.

    Time frame: up to 1 year

  4. Service Use Interview (Service for Children and Adolescence Parent Interview-modified)

    The service use interview was used to measure treatment history and services received during the course of the intervention and follow up.

    Time frame: up to 1 year

  5. Schedule for Affective Disorders and Schizophrenia for School-Age Children (KSADS)

    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.

    Time frame: up to 1 year

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Study locations

1 site
  • Seattle Children's
    Seattle, Washington 98115, United States
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References and documents

Publications

  • Duong MT, Kelly BM, Haaland WL, Matsumiya B, Huey SJ Jr, McCarty CA. Mediators and Moderators of a School-Based Cognitive-Behavioral Depression Prevention Program. Cognit Ther Res. 2016 Oct;40(5):705-716. doi: 10.1007/s10608-016-9780-2. Epub 2016 Apr 28. PubMed 27795599 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 14, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01220635
Lead sponsor
Seattle Children's Hospital
Collaborators
National Institute of Mental Health (NIMH)
Responsible party
Carolyn McCarty (Principal Investigator, Seattle Children's Hospital) — Principal investigator
First posted
Oct 14, 2010
Start date
Oct 2010
Primary completion
Oct 2012
Completion
Oct 2012
Last update
Feb 14, 2014

Study contacts

Carolyn A McCarty, Ph.D.
principal investigator · Seattle Children's Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.

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