Treatment of Depression in Mothers in Home Visitation (MIDIS)
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
This study involves the development and preliminarily testing of In-Home Cognitive Behavioral Therapy (IH-CBT), a psychological treatment grounded in the cognitive model but adapted for administration in conjunction with home visitation. IH-CBT is designed to (1) use the techniques and approaches of CBT which have received strong empirical support, (2) be implemented in the home setting, (3) meet the needs of young postpartum mothers in their first year of home visitation, and (4) be seamlessly integrated with home visitation to maximize the likelihood of recovery from depression, prevent relapse, and increase of the benefits of home visitation. IH-CBT will be delivered by trained therapist who will provide 15 treatment sessions followed by a 1 month booster session. A small-scale randomized clinical trial will be conducted contrasting IH-CBT delivered in conjunction with home visitation and home visitation alone ("typical home visitation"-THV). Mothers in the THV condition will be able to obtain treatment in the community if they choose.
Mothers will be identified based on obtaining a score of ≥12 on the Edinburgh Perinatal Depression Screen administered by home visitors at 3 months postpartum. Final eligibility will be determined based on subsequently obtaining a diagnosis of Major Depressive Disorder (MDD) using the SCID. A comprehensive assessment of depression, other psychiatric symptoms, social support and network, and parenting and child adjustment will be administered at pre-treatment, post-treatment, and 3 month follow-up. Ratings of MDD at post-treatment and follow-up will be conducted by clinicians blind to condition.
The following hypotheses will be tested:
Hypothesis 1. Mothers in IH-CBT will report greater reductions in self-reported and clinician-rated depression at post-treatment and follow up relative to THV.
Hypothesis 2. Mothers in IH-CBT will report improvements in overall functioning, social support, social network, and general psychiatric symptomatology at post-treatment and follow up relative to IH-CBT.
Hypothesis 3. Mothers who recover from depression at post-treatment will report improvements in parenting and child adjustment relative to those who do not recover.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
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Ohio
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Cincinnati, Ohio, États-Unis, 45229
- Cincinnati Children's Hospital Medical Center
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- first-time mother participating in home visitation program
- enrolled in home visitation program for at least 2 months
- 16 years of age or older
- score of 12 or higher on Edinburgh Perinatal Depression Screen at 3 months postpartum
- diagnosis of Major Depressive Disorder using the Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders
- English speaking
Exclusion Criteria:
- lifetime history of bipolar disorder, schizophrenia, mental retardation, organic brain syndrome, antisocial personality disorder
- history of psychosis
- current substance dependence
- current antidepressant use or other mood altering medications and/or current involvement in psychotherapy
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: In-Home Cognitive Behavioral Therapy
Mothers will receive 15 weekly sessions of IH-CBT plus one booster session scheduled 1 month later.
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Adapted form of CBT that is delivered in the home setting, uniquely designed for young, low income new mothers, and is explicitly integrated with home visitation.
IH-CBT is delivered by a masters level therapist.
It consists of 15 weekly sessions and 1 booster session provided 1 month after the 15th session.
Autres noms:
|
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Aucune intervention: typical home visitation
Standard of care in home visitation in which mothers can receive treatment in the community if they choose.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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maternal depression
Délai: 8 months
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Maternal depression as measured by self-report, clinician rating based on semi-structured interview, and psychiatric diagnosis based on semi-structured interview.
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8 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
parenting and child social/emotional functioning
Délai: 8 months
|
Maternal report of parenting stress, observation of parenting behaviors, and maternal report of child social/emotional functioning.
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8 months
|
Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: Robert T. Ammerman, Ph.D., Children's Hospital Medical Center, Cincinnati
Publications et liens utiles
Publications générales
- Ammerman RT, Putnam FW, Bosse NR, Teeters AR, Van Ginkel JB. Maternal Depression in Home Visitation: A Systematic Review. Aggress Violent Behav. 2010 May;15(3):191-200. doi: 10.1016/j.avb.2009.12.002.
- Ammerman RT, Putnam FW, Stevens J, Bosse NR, Short JA, Bodley AL, Van Ginkel JB. An open trial of in-home CBT for depressed mothers in home visitation. Matern Child Health J. 2011 Nov;15(8):1333-41. doi: 10.1007/s10995-010-0691-7.
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 (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- R34MH073867 (Subvention/contrat des NIH des États-Unis)
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