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Completed

NCT Number: NCT01220635

Middle School Matters Study

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

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Key information

Conditions

Depression Behavior Behavioral Symptoms Health Behavior

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seattle Children's

Seattle, Washington, 98115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Positive Thoughts and Actions Program

Behavioral

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).

Individual Support Program

Behavioral

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).

Primary outcomes

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

    Time frame: 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 outcomes

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

    Time frame: 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.

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

    Time frame: 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.

  3. Health Enhancing Behavior Index (HEBI)

    Time frame: up to 1 year

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

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

    Time frame: 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.

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Seattle Children's Hospital

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Prevention of Depression Within Salient Adolescent Contexts

Acronym: MSM

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Oct 14, 2010
Registry last updated
Feb 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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