Clinical trial NCT01220635: Middle School Matters Study
Official title: Prevention of Depression Within Salient Adolescent Contexts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Depressive Symptoms
Depression prevention
Adolescents
School-Based Services
Health Behavior
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2010-10-14
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Moods and Feelings Questionnaire (MFQ; child and parent version)
timeFrame: up to 1 year
Secondary outcomes:
measure: Parent-Child Communication (PCC; child and parent version)
timeFrame: up to 1 year
measure: Behavioral Assessment System for Children-2nd Edition (BASC-2; student, parent, & teacher version)
timeFrame: up to 1 year
measure: Health Enhancing Behavior Index (HEBI)
timeFrame: up to 1 year
measure: Service Use Interview (Service for Children and Adolescence Parent Interview-modified)
timeFrame: up to 1 year
measure: Schedule for Affective Disorders and Schizophrenia for School-Age Children (KSADS)
timeFrame: up to 1 year
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Seattle Children's
state: Washington
Study officials:
affiliation: Seattle Children's Hospital
name: Carolyn A McCarty, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.