A Phase 1 interventional study of CAST-T/HSTS and Brief Intervention in Depression and Substance-Related Disorders, sponsored by University of Washington. Completed at 1 site in United States. Open to participants aged 12 Years to 15 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-08-17.
Sponsored by University of Washington · Phase 1, Interventional, and Prevention
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.
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.
2,124 studies on the registry are indexed under Substance-Related Disorders; 393 are open to participants now.
This study's enrollment of 497 is above the median of 108 across 1,727 interventional studies indexed under Substance-Related Disorders.
Browse Substance-Related Disorders studies →University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.
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Exclusion Criteria:
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: 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
Skills training small group.
Assessment of needs and referral to services as needed.
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.
Time frame: Baseline to 18 months
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...
Time frame: 18 months
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.
| Milestone | CAST-T/HSTS | Brief Intervention |
|---|---|---|
| Started | 241 | 256 |
| Completed | 239 | 253 |
| Not completed | 2 | 3 |
| Withdrew: Withdrawal by subject | 2 | 3 |
| Milestone | CAST-T/HSTS | Brief Intervention |
|---|---|---|
| Started | 239 | 253 |
| Completed | 233 | 247 |
| Not completed | 6 | 6 |
| Withdrew: Withdrawal by subject | 6 | 6 |
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.
| units on a scale | CAST-T/HSTS | Brief Intervention |
|---|---|---|
| Change in Short Moods and Feelings Questionnaire (SMFQ) | 2.19 ± 6.18 | 1.21 ± 6.40 |
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...
| units of a scale | CAST-T/HSTS | Brief Intervention |
|---|---|---|
| School Attachment | 4.53 ± 1.21 | 3.95 ± 1.31 |
Collected over 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CAST-T/HSTS | — | 0/241 (0%) | 0/241 (0%) |
| Brief Intervention | — | 0/256 (0%) | 0/256 (0%) |
| Event | CAST-T/HSTS | Brief Intervention |
|---|---|---|
| Severe depression and/or suicidal risk requiring immediate interventionPsychiatric disorders | 0/241 | 0/256 |
All participants.
| Age, Categorical(Participants) | CAST-T/HSTS | Brief Intervention | Total |
|---|---|---|---|
| <=18 years | 241 | 256 | 497 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | CAST-T/HSTS | Brief Intervention | Total |
|---|---|---|---|
| Mean | 13.5 ± 0.83 | 13.65 ± 0.67 | 13.57 ± 0.75 |
| Sex: Female, Male(Participants) | CAST-T/HSTS | Brief Intervention | Total |
|---|---|---|---|
| Female | 149 | 165 | 314 |
| Male | 92 | 91 | 183 |
| Region of Enrollment(participants) | CAST-T/HSTS | Brief Intervention | Total |
|---|---|---|---|
| United States | 241 | 256 | 497 |
Plan to share: No — Add data has been de-identified. De-identified data is available to share.
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