- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01407783
Systems of Care for New Moms: Integrating Depression Treatment (NUMOMS)
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
NUMOMS involves collaboration between Nurses for Newborns Foundation and Washington University in St. Louis. This study explores the co-location of depression treatment within nurse home visitation and the organizational changes needed to maintain access to evidence-based treatment. Problem Solving Tools (PST) was chosen as the depression treatment because it is well suited for use by non-mental health specialists and for in-home treatment. It is also a brief treatment (4-8 sessions) takes a non-pathologizing approach.
In the first part of the study we will gather information from women and their providers to determine what system and treatment modifications are needed to effectively deliver acceptable depression treatment in home visitation programs. Based on this information, a panel of local and national experts will provide advice on decisions regarding the intervention adaptation. Once these adaptation decisions are made a small group of experts will adapt a PST manual for use in home visitation.
In the second phase of the NUMOMS study we will carry out a small two-arm randomized trial comparing the effectiveness, acceptability, and practicality of PST provided by home visitation RNs versus usual care (referral to mental health specialty care).
Significantly, NUMOMS has the potential to provide home visitation agencies with a viable means of access to effective and acceptable depression treatment for mothers in the face of policy mandates for depression screening.The specific aims are to:
Adapt PST for implementation in nurse home visitation programs.
- Examine internal (organization and client level) and external (community and policy level) factors that may impact upon PST adaptation and delivery in nurse home visitation.
- Build protocols for targeting depression treatment to the woman's symptom severity and patient preferences.
- Develop and routinize protocols for supervision, clinical consultation, and risk assessment for PST provided by nurse home visitors.
- Modify protocols and systems for client tracking and outcomes.
Implement a two-arm randomized pilot study comparing: PST provided by non-mental health home visitation nurses and referral for treatment (Care as Usual).
- Compare outcomes on the Beck Depression Inventory, the Patient Health Questionnaire-9, and Parenting Stress Index for women treated with PST by non-specialty RNs and Care as Usual.
- Track pathways and barriers to care for women referred to mental health specialty care or primary care for medications.
- Develop an R01 for a full scale randomized controlled trial using data on effect sizes and addressing organizational issues, infrastructure needs, and treatment refinements.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Missouri
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Saint Louis, Missouri, États-Unis, 63105
- Washington University and Nurses for Newborns Foundations
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Depressed as indicated by Edinburgh Postpartum Depression Scale or Clinical Checklist
- NFNF client from a certain zip code
- Either pregnant or have a child under the age of 12 months in the home
Exclusion Criteria:
- Under the age of 18
- Severe Mental Illness
- Chemical Dependency
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Problem Solving Tools
The home visitation nurse will teach and utilize the problem solving tools to help low-income depressed mothers.
It is a brief treatment with the a non-pathologizing intervention being done in 4-8 sessions.
|
The problem solving tools was chosen as the depression treatment because it is well suited for use by non-mental health professionals and for in-home treatment.
It is also a brief treatment (4-8 sessions) that takes a non-pathologizing approach.
Autres noms:
|
|
Aucune intervention: Enhanced Referral
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
PHQ-9
Délai: baseline, 6months and 12 months post treatment
|
Measure the reduction of post partum depression after intervention at 6 months and 12 months post treatment.
|
baseline, 6months and 12 months post treatment
|
|
BDI-II
Délai: baseline, 6months &12 months post treatment
|
Measure the reduction of post partum depression after intervention at 6 months and 12 months post treatment.
|
baseline, 6months &12 months post treatment
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Qualitative Interview
Délai: 1 month post treatment
|
Questions asking the participants their feelings about the intervention.
|
1 month post treatment
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Luis H Zayas, Ph.D., Washington University School of Medicine
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 5R34MH083085-02 (Subvention/contrat des NIH des États-Unis)
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