Middle School Matters Study

NCT ID: NCT01220635

Last Updated: 2014-02-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2012-10-31

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.

Conditions

Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Skill Group Program

Positive Thoughts and Actions Program

Group Type: EXPERIMENTAL

Positive Thoughts and Actions Program

Intervention Type: 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

Measure of Adolescent Potential for Suicide (MAPS) - modified

Group Type: ACTIVE_COMPARATOR

Individual Support Program

Intervention Type: 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).

Interventions

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).

Intervention Type: 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).

Intervention Type: BEHAVIORAL

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Seattle Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Carolyn McCarty

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carolyn A McCarty, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Seattle Children's Hospital

Locations

Seattle Children's

Seattle, Washington, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 27795599 (View on PubMed)

Other Identifiers

5R34MH083076-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R34 MH083706

Identifier Type: -

Identifier Source: org_study_id