NCT00071513

Brief Summary

This study will implement a school-based program to prevent depression, academic failure, and substance use in at-risk adolescents transitioning from middle school to high school.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
497

participants targeted

Target at P75+ for phase_1 depression

Timeline
Completed

Started Mar 2003

Longer than P75 for phase_1 depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2003

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 28, 2003

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
9.2 years until next milestone

Results Posted

Study results publicly available

August 17, 2016

Completed
Last Updated

August 17, 2016

Status Verified

July 1, 2016

Enrollment Period

4.3 years

First QC Date

October 24, 2003

Results QC Date

December 6, 2015

Last Update Submit

July 7, 2016

Conditions

Keywords

AdolescentSubstance AbuseAt-risk

Outcome Measures

Primary Outcomes (1)

  • Change in Short Moods and Feelings Questionnaire (SMFQ)

    The Short Moods and Feelings Questionnaire is a 13 item measure of level of self reported depressive symptoms. Each item in scored on a 3-point Likert scale as follows: "True" (0), "Sometimes" (1), and "Not True" (2) rated within the timeframe of the previous two weeks. A total score is obtained; scores can range from 0 to 26. Total scores of 12 or higher may signify that a child/adolescent is suffering from depression. Higher scores on this scale suggest a worse outcome or greater endorsement of depressive symptoms. Change is measured based on two time points baseline to the 18 months follow-up assessment.

    Baseline to 18 months

Secondary Outcomes (1)

  • School Attachment

    18 months

Study Arms (2)

CAST-T/HSTS

EXPERIMENTAL

The CAST-T/HSTS condition combined the Brief Intervention and 12 school based small group sessions which taught skills to enhance personal control (to manage depression, anger, stress), self-esteem, decision making and interpersonal communications. HSTS skills groups were held in the spring of 8th grade with 4 one-on-one booster sessions delivered to the students as 9th graders by HSTP leaders; parents also participated in 4 sessions. HSTS objectives are: 1) to increase the acquisition of coping skills competencies by teaching and practicing strategies taught; 2) to increase social support resources by building a supportive network; 3) to increase the youth's engagement in positive social activities; and 4) to motivate parents to increase their support via parent educational sessions.

Behavioral: CAST-T/HSTS

Brief Intervention

ACTIVE COMPARATOR

Brief Intervention: After each youth and parent completed baseline questionnaires the youth participated in a 1 on 1 standardized clinical follow-up with a trained clinician (blind to study condition) to review areas of concern, based on questionnaire responses including stressors at school, home, and with peers, level of support available and how to access support. The teen and clinician then planned a feedback call to parents, allowing teens to shape requests for support from parents as well as understand exactly what information would be shared with parents. Feedback call to parents reviewed concerns and made recommendations for services as needed. A similar procedure was followed after each assessment for all participants who indicated a risk of clinical depression or self-harm.

Behavioral: Brief Intervention

Interventions

CAST-T/HSTSBEHAVIORAL

Skills training small group.

CAST-T/HSTS

Assessment of needs and referral to services as needed.

Brief Intervention

Eligibility Criteria

Age12 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • At-risk for substance abuse, academic failure, and depression
  • Enrolled in eighth grade in Seattle Public Schools
  • English-speaking

You may not qualify if:

  • Score above the clinical cutoff on the Youth Self Report Aggressive subscale

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (7)

  • Lyon AR, Ludwig KA, Stoep AV, Gudmundsen G, McCauley E. Patterns and Predictors of Mental Healthcare Utilization in Schools and other Service Sectors among Adolescents at Risk for Depression. School Ment Health. 2013 Aug 1;5(3):10.1007/s12310-012-9097-6. doi: 10.1007/s12310-012-9097-6.

    PMID: 24223677BACKGROUND
  • Banh MK, Crane PK, Rhew I, Gudmundsen G, Stoep AV, Lyon A, McCauley E. Measurement equivalence across racial/ethnic groups of the mood and feelings questionnaire for childhood depression. J Abnorm Child Psychol. 2012 Apr;40(3):353-67. doi: 10.1007/s10802-011-9569-4.

    PMID: 21996979BACKGROUND
  • Rhew IC, Simpson K, Tracy M, Lymp J, McCauley E, Tsuang D, Stoep AV. Criterion validity of the Short Mood and Feelings Questionnaire and one- and two-item depression screens in young adolescents. Child Adolesc Psychiatry Ment Health. 2010 Feb 9;4(1):8. doi: 10.1186/1753-2000-4-8.

    PMID: 20181135BACKGROUND
  • Kuo E, Vander Stoep A, McCauley E, Kernic MA. Cost-effectiveness of a school-based emotional health screening program. J Sch Health. 2009 Jun;79(6):277-85. doi: 10.1111/j.1746-1561.2009.00410.x.

    PMID: 19432868BACKGROUND
  • McCormick E, Thompson K, Stoep AV, McCauley E. The Case for School-Based Depression Screening: Evidence From Established Programs. Rep Emot Behav Disord Youth. 2009 Fall;9(4):91-96.

    PMID: 26451134BACKGROUND
  • Blossom JB, Adrian MC, Stoep AV, McCauley E. Mechanisms of Change in the Prevention of Depression: An Indicated School-Based Prevention Trial at the Transition to High School. J Am Acad Child Adolesc Psychiatry. 2020 Apr;59(4):541-551. doi: 10.1016/j.jaac.2019.05.031. Epub 2019 Jun 20.

  • Makover H, Adrian M, Wilks C, Read K, Stoep AV, McCauley E. Indicated Prevention for Depression at the Transition to High School: Outcomes for Depression and Anxiety. Prev Sci. 2019 May;20(4):499-509. doi: 10.1007/s11121-019-01005-5.

Related Links

MeSH Terms

Conditions

DepressionSubstance-Related Disorders

Interventions

Crisis Intervention

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Limitations and Caveats

A significant limitation of this trial was the brief nature of the comparison condition, the Brief Intervention group; findings might reflect "dose" rather than content of the CAST-T/HSTS intervention.

Results Point of Contact

Title
Elizabeth McCauley, PHD, Principal Investigator
Organization
Univeristy of Washington

Study Officials

  • Elizabeth McCauley, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR
  • Ann Vander Stoep, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Psychiatry and Behavioral Sciences

Study Record Dates

First Submitted

October 24, 2003

First Posted

October 28, 2003

Study Start

March 1, 2003

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

August 17, 2016

Results First Posted

August 17, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share

Add data has been de-identified. De-identified data is available to share.

Locations