Middle School to High School Transition Project: Depression and Substance Abuse Prevention (CAST-T/HSTS)

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Elizabeth McCauley, University of Washington
ClinicalTrials.gov Identifier:
NCT00071513
First received: October 24, 2003
Last updated: July 7, 2016
Last verified: July 2016
Results First Received: December 6, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Depression
Substance-Related Disorders
Interventions: Behavioral: CAST-T/HSTS
Behavioral: Brief Intervention

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
8th graders in 6 middle schools completed the screening battery; those with 15+ on the Moods and Feelings Questionnaire and below the clinical cutoff on the Youth Self Report, Aggressive subscale were eligible. 716 met criteria; 497 were randomized. 123 families or youth declined; the rest could not be contacted.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants recruited across 4 annual cohorts, included 241 youth randomized to HSTS and 256 to the Brief Intervention (BI). There were no significant differences between the 2 groups at baseline in terms of gender, race, and socioeconomic status (SES) as well as baseline comparisons of target variables (depression, hopelessness, anxiety, anger).

Reporting Groups
  Description
CAST-T/HSTS

HSTS condition combined the Brief Intervention and the HSTS protocol. HSTS introduced skills to enhance personal control (management of depression, anger and stress), self-esteem, decision making and interpersonal communications. Skills were taught in school based small groups to foster social support with outreach to teachers, peers, and parents. HSTS skills groups were held in the spring of 8th grade followed by four one-on-one booster sessions delivered to the students as 9th graders by HSTS leaders; parents participated in four educational 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.

CAST/HSTS Preventive Intervention: Brief Intervention

Brief Intervention

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.

CAST/HSTS Preventive Intervention: Brief Intervention


Participant Flow for 2 periods

Period 1:   Intervention Component
    CAST-T/HSTS     Brief Intervention  
STARTED     241     256  
COMPLETED     239     253  
NOT COMPLETED     2     3  
Withdrawal by Subject                 2                 3  

Period 2:   Follow-up Assessment
    CAST-T/HSTS     Brief Intervention  
STARTED     239     253  
COMPLETED     233     247  
NOT COMPLETED     6     6  
Withdrawal by Subject                 6                 6  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants.

Reporting Groups
  Description
CAST-T/HSTS

HSTS condition combined the Brief Intervention and the HSTS protocol. HSTS introduced skills to enhance personal control (management of depression, anger and stress), self-esteem, decision making and interpersonal communications. Skills were taught in school based small groups to foster social support with outreach to teachers, peers, and parents. HSTS skills groups were held in the spring of 8th grade followed by four one-on-one booster sessions delivered to the students as 9th graders by HSTP leaders; parents participated in four educational 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.

CAST/HSTS Preventive Intervention: Brief Intervention

Brief Intervention

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.

CAST/HSTS Preventive Intervention: Brief Intervention

Total Total of all reporting groups

Baseline Measures
    CAST-T/HSTS     Brief Intervention     Total  
Number of Participants  
[units: participants]
  241     256     497  
Age  
[units: participants]
     
<=18 years     241     256     497  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age  
[units: years]
Mean (Standard Deviation)
  13.5  (0.83)     13.65  (0.67)     13.57  (0.75)  
Gender  
[units: participants]
     
Female     149     165     314  
Male     92     91     183  
Region of Enrollment  
[units: participants]
     
United States     241     256     497  



  Outcome Measures
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1.  Primary:   Change in Short Moods and Feelings Questionnaire (SMFQ)   [ Time Frame: Baseline to 18 months ]

2.  Secondary:   School Attachment   [ Time Frame: 18 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Elizabeth McCauley, PHD, Principal Investigator
Organization: Univeristy of Washington
phone: 206-987-2579
e-mail: eliz@uw.edu


Publications:

Responsible Party: Elizabeth McCauley, University of Washington
ClinicalTrials.gov Identifier: NCT00071513     History of Changes
Other Study ID Numbers: 21484-EG
R01MH061984 ( US NIH Grant/Contract Award Number )
Study First Received: October 24, 2003
Results First Received: December 6, 2015
Last Updated: July 7, 2016
Health Authority: United States: Institutional Review Board