Middle School Matters Study

Not Applicable

Completed

• Conditions: Depression
• Interventions: Behavioral: Positive Thoughts and Actions Program; Behavioral: Individual Support Program

• Registration Number: NCT01220635
• Lead Sponsor: Seattle Children's Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-10-05
• Study First Submitted QC: 2010-10-12
• Study First Posted: 2010-10-14
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-13
• Last Update Posted: 2014-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

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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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Skill Group Program	Positive Thoughts and Actions Program	Positive Thoughts and Actions Program
Individual Support Program	Individual Support Program	Measure of Adolescent Potential for Suicide (MAPS) - modified

Primary Outcome Measures

Name	Time	Method
Moods and Feelings Questionnaire (MFQ; child and parent version)	up to 1 year	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

Name	Time	Method
Parent-Child Communication (PCC; child and parent version)	up to 1 year	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.
Schedule for Affective Disorders and Schizophrenia for School-Age Children (KSADS)	up to 1 year	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.
Health Enhancing Behavior Index (HEBI)	up to 1 year	Health behaviors (diet, exercise, and sleep) are self-reported by the youth on the HEBI.
Behavioral Assessment System for Children-2nd Edition (BASC-2; student, parent, & teacher version)	up to 1 year	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.
Service Use Interview (Service for Children and Adolescence Parent Interview-modified)	up to 1 year	The service use interview was used to measure treatment history and services received during the course of the intervention and follow up.

Trial Locations

Locations (1)

Seattle Children's; 🇺🇸 Seattle, Washington, United States