DepressionPhase 1CAST-T/HSTSNCT00071513

Middle School to High School Transition Project: Depression and Substance Abuse Prevention

A Phase 1 study testing CAST-T/HSTS and Brief Intervention in people with Depression and Substance-Related Disorders, run by University of Washington at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 12 to 15 yearsHealthy volunteers can take part
Conditions the study is for: Depression, Substance-Related Disorders
What is being tested?: CAST-T/HSTS and Brief Intervention
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 497 participants
Where: 1 siteUnited States
Study dates: Mar 2003to Jun 2007
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 to 15 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Washington
Seattle, Washington, 98195

Other trials in United States

About this study

Official title: Middle School to High School Transition Project

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.

Read the detailed description

The transition from middle school to high school presents important challenges for adolescents. Programs that enhance personal efficacy and social support resources may prevent at-risk students from developing behaviors that can lead to substance use, academic failure, and depression. This study will implement a skills-based program called Coping and Support Training for the Transition (CAST-T) as a preventive intervention for at-risk students.

At-risk students in eighth grade will be randomly assigned to receive either CAST-T or school as usual. The CAST-T program will initially be delivered in twelve sessions over 6 weeks in the middle school setting. The program includes booster sessions, case management, structured home-based parent education, and support and skills training throughout the transition period. Participants will be assessed from the beginning of eighth grade to the end of ninth grade. Vulnerability to academic problems and depression will be assessed with school records and self-report scale scores.

Conditions: Depression, Substance-Related Disorders
Being tested: CAST-T/HSTS, Brief Intervention
Keywords: Adolescent, Substance Abuse, At-risk
Medical subject headings: Depression, Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CAST-T/HSTSBehavioural
Skills training small group.
Brief InterventionBehavioural
Assessment of needs and referral to services as needed.

Study groups in NCT00071513
Study group	Role	What they receive
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. Receives: 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. Receives: Behavioral: Brief Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline to 18 months

Secondary outcomes (1)

School Attachment
School attachment measure consisted of 4 items. Item responses range from 0 (unsatisfied, rarely attended, not involved, etc.) to 6 (highly satisfied, regularly attended, very involved, etc). Scores could range from 0 to 36 with higher scores indicating more positive school attachment. Item were:
My overall satisfaction with classes was… Overall, how safe did school feel last semester… Overall, how friendly did school feel… How involved were you in school activities…
Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2003Jun 2007

First posted28 Oct 2003 (estimated)
Study startMar 2003
Primary completionJun 2007
Study completionJun 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (7)Papers the sponsor has linked to this study.
Other trials for DepressionStudies of the same condition, open and under way.
More trials run by University of WashingtonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 497 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00071513
Sponsor's protocol ID: 21484-EG
Other IDs: R01MH061984
Acronym: CAST-T/HSTS
Status last verified: Jul 2016
First submitted: 24 Oct 2003
Last updated: 17 Aug 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No: Add data has been de-identified. De-identified data is available to share.

Publications

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.
PubMed 24223677
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.
PubMed 21996979
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.
PubMed 20181135
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.
PubMed 19432868
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.
PubMed 26451134
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.
PubMed 31228560
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.
PubMed 30852711

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 17 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Middle School to High School Transition Project
ClinicalTrials.gov ID: NCT00071513
Acronym / sponsor ID: CAST-T/HSTS / 21484-EG
Conditions: Depression, Substance-Related Disorders
Keywords: Adolescent, Substance Abuse, At-risk
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 497 participants (actual)
Lead sponsor: University of WashingtonUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: Mar 2003
Primary completion: Jun 2007 (actual)
Study completion: Jun 2007 (actual)
First posted: 28 Oct 2003 (estimated)
Results: Posted 17 Aug 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
CAST-T/HSTS	Experimental	Behavioral: CAST-T/HSTSThe 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.
Brief Intervention	Active comparator	Behavioral: Brief InterventionBrief 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.

Who may qualify

Ages: 12 to 15 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (3 listed)

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

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CAST-T/HSTSSkills training small group.	Behavioural	CAST-T/HSTS
Brief InterventionAssessment of needs and referral to services as needed.	Behavioural	Brief Intervention

Primary outcome

Change in Short Moods and Feelings Questionnaire (SMFQ)
Time frame: Baseline to 18 months
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.

1 secondary outcome

School Attachment
Time frame: 18 months

Results and safety

Results posted to the registry on 17 Aug 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CAST-T/HSTS	241	239
Brief Intervention	256	253

Primary outcome: Change in Short Moods and Feelings Questionnaire (SMFQ)

Time frame: Baseline to 18 months. Mean (Standard Deviation). Unit: units on a scale

Measure	CAST-T/HSTS n = 233	Brief Intervention n = 247
Value	2.19 (6.18)	1.21 (6.40)

CAST-T/HSTS vs Brief Intervention: p <0.05, t-test, 2 sided
CAST-T/HSTS vs Brief Intervention: p <0.01, t-test, 2 sided

Population analysed: The main study hypothesis was that at-risk middle school students randomly assigned to participate in the CAST-T/HSTS versus the Brief Intervention would demonstrate a greater reduction in self-reported depressive symptoms after the 8th grade intervention as well as lower rate of increase in depressive symptoms at the 18 mos. follow-up.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 18 months, from initial screening which began in January of the 8th grade year to final follow-up assessments which were conducted in spring of the ith grade year (April to June) approximately 18 months later.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CAST-T/HSTS	0 of 241 (0%)	0 of 241 (0%)	Not reported
Brief Intervention	0 of 256 (0%)	0 of 256 (0%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 24223677Lyon 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.
Background: PubMed 21996979Banh 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.
Background: PubMed 20181135Rhew 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.
Background: PubMed 19432868Kuo 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.
Background: PubMed 26451134McCormick 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.
Derived from this study: PubMed 31228560Blossom 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.
Derived from this study: PubMed 30852711Makover 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.
Project websiteLink provided by the sponsor.
Individual participant dataSharing planned: No. Add data has been de-identified. De-identified data is available to share.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Elizabeth McCauley, PhD principal investigator

University of Washington

Ann Vander Stoep, PhD principal investigator

University of Washington

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CAST-T/HSTS and Brief Intervention in people with Depression and Substance-Related Disorders, run by University of Washington at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Short Moods and Feelings Questionnaire (SMFQ) (time frame: Baseline to 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00071513, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2016.