Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Collaborative Care for Children's Mental Health Problems

16 oktober 2019 bijgewerkt door: Johns Hopkins University

Collaborative Child Mental Healthcare in Low-Resource Settings

Background: Mental health problems cause a disproportionate burden of disability among children and youth compared to adults. Primary care plays an important role in efforts to prevent and intervene early in the course of child and adolescent mental health problems. While research with adults has shown the feasibility of integrating mental health care into primary care settings, there have been few studies among children and youth. Evidence remains lacking that integration is feasible in diverse settings, that it improves outcomes, and that methods can be developed to address the mixed symptoms of emerging child/youth problems and their overlap with developmental and parental disorders.

Goals: The purpose of this project is to test the effectiveness of adding a child/youth mental health component into an existing collaborative care program for adult mental health problems. The work will refine a framework for efficient cultural adaption and tailoring of an existing child/youth primary care mental health intervention and then test whether the tailored intervention results in improved child and parent outcomes. The work will also provide evidence about the mechanisms by which those outcomes are achieved and what factors influence uptake of the child/youth component by general practitioners (GPs). These results should be generalizable to low and middle income countries and to underserved areas of the US where there are minimal child mental health resources and family physicians provide the bulk of medical care for children and youth.

Methods: The planned work involves the adaptation/tailoring process followed by a trial with 45 GPs already engaged in collaborative care for adults; the trial will study adding collaborative care for children ages 5-15. GPs will be randomly assigned in groups to begin 6-month control periods involving child mental health screening and referral. They will then receive child/youth training and begin second 6-month periods of screening plus ongoing coaching and booster sessions and collaborative management. Primary outcomes will be measured by recruiting and following for 6 months two cohorts of children/youth and their parents (one control, one collaborative care). Data collected from GPs, parents, youth, and the collaborative care data system will allow measurement of key factors that determine the program's success in helping children and families.

Studie Overzicht

Gedetailleerde beschrijving

Most mental health problems begin in childhood and adolescence, but delays in receipt of treatment are measured in years to decades. As a result, mental health problems cause a disproportionate burden of disability among children and youth compared to adults, and have a major impact on life course development. Primary care services can play an important role in efforts to prevent and intervene early in the course of child and adolescent mental health problems. Primary care services are widely available and offer an opportunity to interact simultaneously with children and their parents, treat mental health in the context of medical and developmental concerns, and reduce the stigma associated with visiting identifiable mental health facilities. While research with adults has shown the feasibility of integrating mental health care into primary care settings, and that it reduces the burden of mental illnesses, there have been few studies among children and youth and none that address a combined task-shifting/stepped care model. In addition, evidence remains lacking that integration is feasible in diverse settings, that it improves clinical outcomes, and has the potential to be scaled up.

One essential element of integration is "shifting" first-line mental health engagement and treatment tasks to primary care providers. Task shifting requires mental health interventions that fit both the local context of primary care services and the local nature of the problems seen. To date, most adult and child integration models have targeted single conditions at diagnostic levels and relied on additional co-located personnel to provide treatment. To achieve goals of prevention and early intervention, integration models for children and youth must take into account that the symptoms of emerging child and youth problems often suggest multiple possible disorders and can be co-morbid with developmental and parental disorders. By definition, emerging problems amenable to early intervention are likely to be "subthreshold" and not qualify for treatment in a specialty setting, especially when resources are scarce, even though early intervention holds the promise of preventing progression.

The purpose of this trial is to test the effectiveness of adding a child/youth mental health component - tailored to fit the context of primary care into an existing collaborative care program supporting primary care management of adult mental health problems.

The trial's specific aims are to conduct an early-stage hybrid effectiveness-implementation trial with 45 general practitioners in two cities focusing on:

  1. Whether delivery of tailored interventions by primary care providers results in improved child and parent mental health outcomes; and exploring the mechanisms by which the interventions achieve those outcomes (which conditions are more likely to be identified and treated, which treatments have the greatest uptake by parents and youth)
  2. Whether a coordinated program of training, ongoing coaching, and collaborative care results in uptake of the tailored intervention by primary care providers as evidenced by treatment provided in primary care and participation in collaborative care through consultation and referral.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

1111

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

5 jaar tot 15 jaar (Kind)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Brought by parent to see general practitioner

Exclusion Criteria:

  • Child is acutely physically ill, in acute pain, or general practitioner feels family should not be approached about the study.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Onderzoek naar gezondheidsdiensten
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Control
Children enrolled during the control phase will receive care under the Current collaborative care protocol. Participating general practitioners are currently trained to recognize child mental health problems and refer them to partner community mental health centers for treatment.
General practitioners have been trained to recognize children's mental health problems and to refer them to a partner community mental health center. They receive feedback about the referral but are not encouraged to take on care for the child themselves.
Experimenteel: Intervention
Children enrolled during the intervention phase will receive Training in management of children's mental health problems. This will involve treatment by their general practitioner in collaboration with a partner community mental health center; children meeting certain criteria for severity, or whose parents prefer center treatment, will be immediately referred.
General practitioners will be trained using internationally-developed materials, including the World Health Organization's "mental health need/service gap (mhGAP)" materials and others, adapted for the trial setting (based on formative work that is part of the project). They will be assisted and monitored as part of the ongoing collaborative care program in which they are participating.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in child mental health-related symptoms
Tijdsspanne: 6 months post enrollment
Change from baseline to 6-month follow-up on total symptom score of Strengths and Difficulties Questionnaire
6 months post enrollment

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in child mental health-related functioning
Tijdsspanne: 6 months post enrollment
Change from baseline to 6-month follow-up on "Impact supplement" score of Strengths and Difficulties Questionnaire
6 months post enrollment
Change in maternal mental health-related symptoms
Tijdsspanne: 6 months post enrollment
Change from baseline to 6-month follow-up on total score of General Health Questionnaire
6 months post enrollment

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: Lawrence S Wissow, MD, Johns Hopkins School of Medicine

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 augustus 2017

Primaire voltooiing (Werkelijk)

30 september 2019

Studie voltooiing (Werkelijk)

30 september 2019

Studieregistratiedata

Eerst ingediend

5 mei 2017

Eerst ingediend dat voldeed aan de QC-criteria

5 mei 2017

Eerst geplaatst (Werkelijk)

9 mei 2017

Updates van studierecords

Laatste update geplaatst (Werkelijk)

17 oktober 2019

Laatste update ingediend die voldeed aan QC-criteria

16 oktober 2019

Laatst geverifieerd

1 oktober 2019

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

Ja

Beschrijving IPD-plan

Will be provided as part of the National Database for Clinical Trials Related to Mental Illness (NDCT)

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Klinische onderzoeken op Current collaborative care protocol

Abonneren