Middle School Matters Study (MSM)
13 février 2014 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
120
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Washington
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Seattle, Washington, États-Unis, 98115
- Seattle Children's
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Skill Group Program
Positive Thoughts and Actions Program
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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).
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Comparateur actif: Individual Support Program
Measure of Adolescent Potential for Suicide (MAPS) - modified
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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).
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Moods and Feelings Questionnaire (MFQ; child and parent version)
Délai: 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.
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up to 1 year
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Parent-Child Communication (PCC; child and parent version)
Délai: 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.
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up to 1 year
|
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Behavioral Assessment System for Children-2nd Edition (BASC-2; student, parent, & teacher version)
Délai: 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.
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up to 1 year
|
|
Health Enhancing Behavior Index (HEBI)
Délai: up to 1 year
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Health behaviors (diet, exercise, and sleep) are self-reported by the youth on the HEBI.
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up to 1 year
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Service Use Interview (Service for Children and Adolescence Parent Interview-modified)
Délai: up to 1 year
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The service use interview was used to measure treatment history and services received during the course of the intervention and follow up.
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up to 1 year
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Schedule for Affective Disorders and Schizophrenia for School-Age Children (KSADS)
Délai: up to 1 year
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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.
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up to 1 year
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Carolyn A McCarty, Ph.D., Seattle Children's Research Institute
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 octobre 2010
Achèvement primaire (Réel)
1 octobre 2012
Achèvement de l'étude (Réel)
1 octobre 2012
Dates d'inscription aux études
Première soumission
5 octobre 2010
Première soumission répondant aux critères de contrôle qualité
12 octobre 2010
Première publication (Estimation)
14 octobre 2010
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
14 février 2014
Dernière mise à jour soumise répondant aux critères de contrôle qualité
13 février 2014
Dernière vérification
1 février 2014
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- R34 MH083706
- 5R34MH083076-03 (Subvention/contrat des NIH des États-Unis)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .