Trial Outcomes & Findings for Middle School to High School Transition Project: Depression and Substance Abuse Prevention (NCT NCT00071513)
NCT ID: NCT00071513
Last Updated: 2016-08-17
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
497 participants
Primary outcome timeframe
Baseline to 18 months
Results posted on
2016-08-17
Participant Flow
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.
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).
Participant milestones
| Measure |
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
|
|---|---|---|
|
Intervention Component
STARTED
|
241
|
256
|
|
Intervention Component
COMPLETED
|
239
|
253
|
|
Intervention Component
NOT COMPLETED
|
2
|
3
|
|
Follow-up Assessment
STARTED
|
239
|
253
|
|
Follow-up Assessment
COMPLETED
|
233
|
247
|
|
Follow-up Assessment
NOT COMPLETED
|
6
|
6
|
Reasons for withdrawal
| Measure |
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
|
|---|---|---|
|
Intervention Component
Withdrawal by Subject
|
2
|
3
|
|
Follow-up Assessment
Withdrawal by Subject
|
6
|
6
|
Baseline Characteristics
Middle School to High School Transition Project: Depression and Substance Abuse Prevention
Baseline characteristics by cohort
| Measure |
CAST-T/HSTS
n=241 Participants
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
n=256 Participants
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
n=497 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
241 Participants
n=5 Participants
|
256 Participants
n=7 Participants
|
497 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
13.5 years
STANDARD_DEVIATION 0.83 • n=5 Participants
|
13.65 years
STANDARD_DEVIATION 0.67 • n=7 Participants
|
13.57 years
STANDARD_DEVIATION 0.75 • n=5 Participants
|
|
Sex: Female, Male
Female
|
149 Participants
n=5 Participants
|
165 Participants
n=7 Participants
|
314 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
92 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
183 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
241 participants
n=5 Participants
|
256 participants
n=7 Participants
|
497 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 18 monthsPopulation: 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.
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.
Outcome measures
| Measure |
CAST-T/HSTS
n=233 Participants
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
n=247 Participants
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
|
|---|---|---|
|
Change in Short Moods and Feelings Questionnaire (SMFQ)
|
2.19 units on a scale
Standard Deviation 6.18
|
1.21 units on a scale
Standard Deviation 6.40
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: T-test differences for HSTS versus Brief Intervention on the School Attachment scale.
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…
Outcome measures
| Measure |
CAST-T/HSTS
n=233 Participants
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
n=247 Participants
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
|
|---|---|---|
|
School Attachment
|
4.53 units of a scale
Standard Deviation 1.21
|
3.95 units of a scale
Standard Deviation 1.31
|
Adverse Events
CAST-T/HSTS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Brief Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CAST-T/HSTS
n=241 participants at risk
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
n=256 participants at risk
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
|
|---|---|---|
|
Psychiatric disorders
Severe depression and/or suicidal risk requiring immediate intervention
|
0.00%
0/241 • 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.
At baseline each youth was interviewed by a trained clinician with a feedback call to parents. Thereafter, at each assessment, any student with responses indicating risk of clinical depression or self-harm was immediately assessed by a clinical specialist who worked with parents and the school counselors to develop an intervention/support plan.
|
0.00%
0/256 • 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.
At baseline each youth was interviewed by a trained clinician with a feedback call to parents. Thereafter, at each assessment, any student with responses indicating risk of clinical depression or self-harm was immediately assessed by a clinical specialist who worked with parents and the school counselors to develop an intervention/support plan.
|
Other adverse events
Adverse event data not reported
Additional Information
Elizabeth McCauley, PHD, Principal Investigator
Univeristy of Washington
Phone: 206-987-2579
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place