Middle School Matters Study (MSM)
13. februar 2014 oppdatert av: Carolyn McCarty, Seattle Children's Hospital
Prevention of Depression Within Salient Adolescent Contexts
This study aims to evaluate the short-term and long-term efficacy of two preventative intervention approaches designed to support middle school youth.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
This study involve two parts: Part 1 entailed screening 7th and 8th graders from 4 public middle schools to identify students who may be showing moderate signs of stress.
Students who score at the designated cutoff on a depression symptoms measure received a brief check-in to determine eligibility for the follow up randomized trial (Part 2).
An "indicated" sample of 120 adolescents in the 7th and 8th grade and their caregivers were randomly assigned to a brief, Individual Support Program (ISP) comparison group or a Skills Group Program.
Research interviews were conducted at multiple timepoints with students and caregivers, and teacher questionnaires were used to examine changes in outcome measures.
Following completion of the intervention, all participants were followed for 12-months.
Studietype
Intervensjonell
Registrering (Faktiske)
120
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Washington
-
Seattle, Washington, Forente stater, 98115
- Seattle Children's
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- 7th and 8th grade students at 4 participating middle schools
- Score 14 or above on the Mood and Feelings Questionnaire at screening (approximately top 25%)
- No imminent plans to move or change to non-participating school
- At minimum 6th grade language skills
- Agree to participate in random assignment and research interviews
- One Parent/caregiver willing to complete research interviews
Exclusion Criteria:
- Student with past or current Major Depressive Disorder (MDD) or Probable MDD
- Students with parents who do not speak English or Spanish
- Students in concurrent treatment
- Students in self-contained classroom, or with cognitive delays, or emotional behavioral problems that would preclude them from benefiting from the group or being a good group member
- Parent not willing to complete research interviews
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Skill Group Program
Positive Thoughts and Actions Program
|
Students in the skills group will attend a 12-session (50 minutes each), 12-week program with 4-6 other students.
The skills group will take place at school during school hours.
Parents in the skill group will be asked to participate in two parent group workshops to take place at their child's school or other participating middle school (2-hours each).
In addition, the skill group leader will conduct two individual family meetings with the student and parent(50 minutes each).
|
|
Aktiv komparator: Individual Support Program
Measure of Adolescent Potential for Suicide (MAPS) - modified
|
Students will be individually interviewed (60-90 minutes) at school to review areas of stress and support.
The health professional conducting the interview will reinforce the student's strengths, and provide connections to sources of help from caring adults at home and at school.
Parents will be called following the assessment to help the family locate appropriate resources if needed (e.g., tutoring resources, school counselor).
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Moods and Feelings Questionnaire (MFQ; child and parent version)
Tidsramme: up to 1 year
|
Depressive symptoms of the child are assessed on the MFQ.
Youth completed the MFQ at all 4 timepoints, parent ratings of students symptoms were collected at baseline, post-intervention, and 12 month follow up.
|
up to 1 year
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Parent-Child Communication (PCC; child and parent version)
Tidsramme: up to 1 year
|
Parent child communication were assessed using the child and parent version of the PCC.
Children completed the PCC at all 4 timepoints, parent ratings were collected at baseline, post-intervention, and 12 month follow up.
|
up to 1 year
|
|
Behavioral Assessment System for Children-2nd Edition (BASC-2; student, parent, & teacher version)
Tidsramme: up to 1 year
|
The adolescent version of the Teacher Rating Scale, Parent Rating Scale, and the Student Self-Report of Personality of the BASC-2 were used to assess school functioning and social functioning.
|
up to 1 year
|
|
Health Enhancing Behavior Index (HEBI)
Tidsramme: up to 1 year
|
Health behaviors (diet, exercise, and sleep) are self-reported by the youth on the HEBI.
|
up to 1 year
|
|
Service Use Interview (Service for Children and Adolescence Parent Interview-modified)
Tidsramme: up to 1 year
|
The service use interview was used to measure treatment history and services received during the course of the intervention and follow up.
|
up to 1 year
|
|
Schedule for Affective Disorders and Schizophrenia for School-Age Children (KSADS)
Tidsramme: up to 1 year
|
The depression module of the KSADS was used to assess DSM-IV symptoms of major depression and depressive disorder at the 12-month follow up.
|
up to 1 year
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Carolyn A McCarty, Ph.D., Seattle Children's Research Institute
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. oktober 2010
Primær fullføring (Faktiske)
1. oktober 2012
Studiet fullført (Faktiske)
1. oktober 2012
Datoer for studieregistrering
Først innsendt
5. oktober 2010
Først innsendt som oppfylte QC-kriteriene
12. oktober 2010
Først lagt ut (Anslag)
14. oktober 2010
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
14. februar 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
13. februar 2014
Sist bekreftet
1. februar 2014
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- R34 MH083706
- 5R34MH083076-03 (U.S. NIH-stipend/kontrakt)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .