Perturber les SDOH pour améliorer les résultats en matière de consommation de substances et de santé mentale pour les parents des régions rurales
Perturber les déterminants sociaux de la santé pour améliorer la consommation de substances et les résultats en matière de santé mentale des parents des régions rurales
The study will evaluate the effectiveness of the Just Care for Families program in preventing Oregon Department of Human Services (ODHS)-involved parents in rural communities from escalating opioid and/or methamphetamine use and mental health disorders by disrupting the associated social risk factors of health (SRFOH). In addition, investigators will examine the impacts of SRFOH on Just Care treatment and the associated costs from the perspective of provider clinics delivering Just Care. Just Care is a behavioral intervention for the treatment of parental substance abuse and child neglect for families involved in the child welfare system. Just Care involves treatment components, supported by ongoing purposeful engagement: (1) Substance use treatment; (2) Mental health treatment; (3) Parent management training; (4) Community building; (5) Systems Navigation; and (6) Addressing basic needs. This study is supported by and included in the Helping to End Addiction Long-term Initiative (https://heal.nih.gov/).
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
This study provides multiple tests of the mechanisms by which Just Care for Families disrupts the effects of lifetime social risk factors of health (SRFOH) on ultimate outcomes of preventing escalation of opioid and/or methamphetamine use and suicide (ideation, intention, attempts). Just Care for Families 's effect on these outcomes is hypothesized to occur through two mechanisms of action: (1) improvement in malleable SRFOH (direct targets of intervention) and (2) improvement in substance use and mental health problems (intermediate prevention outcomes). Analyses will examine whether the effects vary as a function of non-malleable external, structural SRFOH, such as community poverty and healthcare service availability. Additionally, system dynamics will be used to examine patterns of influence between SRFOH and Just Care for Families intervention targets, case outcomes, and associated costs. This study is supported by and included in the Helping to End Addiction Long-term Initiative (https://heal.nih.gov/).
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Oregon
-
Eugene, Oregon, États-Unis, 97401
- Chestnut Health Systems
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
Parents:
- Any substance misuse in the last year
- Parent of a child, age 0-18
- Resident of participating county (Lane, Linn, Benton, Douglas, Lincoln)
- Insured by Oregon Health Plan (Medicaid)
- Access to a computer or smartphone; or wireless/cellular connection if a device were to be provided; or reliable access to a landline to receive a brief weekly phone assessment in place of the digital assessment
Clinical Staff:
- clinician at a participating clinic
- Providing Just Care for Families services to parents in the study at any point during study
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Just Care for Families
Parents receiving Just Care for Families |
Just Care for Families is a behavioral intervention to address the needs of families involved in or at-risk for involvement with the child welfare system. Just Care involves treatment components, supported by ongoing purposeful engagement: (1) Substance use treatment including contingency management and positive reinforcement, day planning, healthy environments and peer choices, and refusal skills; (2) Mental health treatment including cognitive behavioral therapy, developing healthy coping skills, emotion regulation skills, exposure therapy, and referral for medication management; (3) Parent management training including parenting skills, nurturing and attachment, reinforcement, emotion regulation, supervision, structure, non-harsh discipline, and nutrition; (4) Community building including indigenous and external social supports; (5) Systems navigation; and (6) provision of assistance with basic needs including assistance with housing and employment. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in opioid use
Délai: baseline, 9 months, and 18 months
|
Changes in any opioid use in past 30 days as assessed by Addiction Severity Index opioid use items (heroin, methadone, and other). |
baseline, 9 months, and 18 months
|
|
Change in methamphetamine use
Délai: baseline, 9 months, 18 months
|
Changes in any methamphetamine use in past 30 days as assessed by Addiction Severity Index. |
baseline, 9 months, 18 months
|
|
Change in depression severity
Délai: Baseline, 9 months and 18 months
|
Changes in intensity of depression-related distress in the past week as measured by the Brief Symptom Inventory Depression Subscale items (Sum of responses to 6 Likert-type items, range 0-24). |
Baseline, 9 months and 18 months
|
|
Change in anxiety
Délai: baseline, 9 months, 18 months
|
Changes in intensity of anxiety-related distress in the past week as measured by the Brief Symptom Inventory Anxiety Subscale items (Sum of responses to 6 Likert-type items, range 0-24). |
baseline, 9 months, 18 months
|
|
Change in Social Risk Factors Needs
Délai: Baseline through 18 months (weekly)
|
Changes in total number of needs or problems across Social Risk Factors of Health domains as assessed by PhenX toolkit items in a weekly parent survey. The number of items endorsed in the past week out of 43 items comprising 7 risk factor domains are scored. Domains include Work and money, neighborhood and transportation, education and training, food, community safety and support, healthcare system, internet and phone, and health and well-being. |
Baseline through 18 months (weekly)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Changes in opioid or methamphetamine use as measured by Urinalysis testing
Délai: Baseline through 18 months (weekly)
|
Positive urine drug screen for opioids or methamphetamines as measured by 12-panel instant urine toxicology screens and fentanyl strip screens. |
Baseline through 18 months (weekly)
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Lisa Saldana, PhD, Chestnut Health Systems
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
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
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 1172-0623
- R01DA057556 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
As part of the NIH Helping to End Addiction Long-term (HEAL) Initiative, this study will follow the data sharing protocols as outlined by the HEAL Data Sharing Policy.
Délai de partage IPD
Data will be shared upon acceptance of the data for publication or within six months after the completion of Baseline data collection (within 12 months for the 9-month and 18-month assessments), whichever is earlier.
Critères d'accès au partage IPD
Data will be deposited in the NAHDAP data repository. These data will be shared with investigators working under an institution with a Federal Wide Assurance (FWA) and could be used for secondary study purposes. Requested primary study data and metadata will be made available to investigators according to the policies of the NAHDAP.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- RSE
Informations sur les médicaments et les dispositifs, documents d'étude
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