- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT00071513
Middle School to High School Transition Project: Depression and Substance Abuse Prevention (CAST-T/HSTS)
Middle School to High School Transition Project
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Faza 1
Kontakty i lokalizacje
Lokalizacje studiów
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Washington
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Seattle, Washington, Stany Zjednoczone, 98195
- University of Washington
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- At-risk for substance abuse, academic failure, and depression
- Enrolled in eighth grade in Seattle Public Schools
- English-speaking
Exclusion Criteria:
- Score above the clinical cutoff on the Youth Self Report Aggressive subscale
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: CAST-T/HSTS
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.
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Skills training small group.
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Aktywny komparator: 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.
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Assessment of needs and referral to services as needed.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Change in Short Moods and Feelings Questionnaire (SMFQ)
Ramy czasowe: Baseline to 18 months
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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.
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Baseline to 18 months
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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School Attachment
Ramy czasowe: 18 months
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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… |
18 months
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Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Elizabeth McCauley, PhD, University of Washington
- Główny śledczy: Ann Vander Stoep, PhD, University of Washington
Publikacje i pomocne linki
Publikacje ogólne
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Przydatne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 21484-EG
- R01MH061984 (Grant/umowa NIH USA)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
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Badania kliniczne na CAST-T/HSTS
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Assistance Publique Hopitaux De MarseilleNieznanyUżywanie konopi indyjskichFrancja
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McMaster UniversityCanadian Institutes of Health Research (CIHR); Institute for Clinical Evaluative... i inni współpracownicyZakończony
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Singapore General HospitalDuke-NUS Graduate Medical SchoolZakończony
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Ball State UniversityIndiana University; University of ToledoRekrutacyjnyZaburzenia ze spektrum autyzmu | Zaburzenie autystyczne | AutyzmStany Zjednoczone
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Tel Aviv UniversityZakończonyZaburzenia związane z używaniem substancjiIzrael
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University of MinnesotaRekrutacyjnyCukrzyca | Owrzodzenie stopy | Wrzód | Owrzodzenie stopy cukrzycowej | Owrzodzenie stopy, cukrzyca | Wrzód stopy | Wrzód, Noga | Wrzód kostkiStany Zjednoczone
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Florida State UniversityZakończonyWrażliwość lękowa
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University of MiamiZakończonyStopa cukrzycowa | Owrzodzenie stopyStany Zjednoczone
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Oregon Health and Science UniversityNational Center for Complementary and Integrative Health (NCCIH)ZakończonyNeuropatia cukrzycowaStany Zjednoczone
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Centre Hospitalier Universitaire de NīmesRekrutacyjny