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Integrated Maternal Psychosocial Assessment to Care Trial (IMPACT) Full Trial

11. november 2019 oppdatert av: Dawn Kingston, University of Calgary

Integrated Maternal Psychosocial Assessment to Care Trial (IMPACT): Intervening Early to Improve Maternal and Family Well-being.

We hypothesize that the intervention will: (1) offer a feasible approach for providing mental healthcare to pregnant women and have a high level of acceptability by pregnant women and healthcare providers; (2) reduce symptoms of depression, stress, anxiety, and parenting stress; improve parenting competence, coping, and relationship adjustment compared to usual care; and (3) reduce the risk of poor maternal-infant attachment. As such, this early intervention holds promise for reducing maternal mental health morbidity and its negative influences on infants, children, and families.

Studieoversikt

Status

Ukjent

Forhold

Detaljert beskrivelse

One of the main reasons that women do not receive treatment is that their mood and anxiety problems are not detected. Despite recommendations and high rates of acceptance by providers and women, only a minority of providers conduct psychosocial assessments as part of routine prenatal care. Computer-based 'screening' is an acceptable and feasible approach to assessment of sensitive issues including prenatal and postnatal intimate partner violence, mental health problems, and postpartum depression by patients and providers. It is well-suited for busy clinical settings and is advantageous in that it offers a consistent approach to assessment, is resource-sparing, can be tailored to meet the specific needs of patients, can be used with audio/video for low literacy, provides a real-time summary for patients/providers,achieves similar or higher rates of disclosure of violence and mental health problems, and is preferred by patients because they perceive it as more anonymous compared to interviews or questionnaires.

However, psychosocial assessment on its own is ineffective in preventing or treating mood disorders and unethical in the absence of treatment options. As such, many providers do not assess pregnant women for mood disorders because non-pharmacological treatments are frequently unavailable and pregnant women prefer them. Cognitive behavioural therapy (CBT) is a highly effective, non-pharmacological treatment for depression and anxiety and is recommended by perinatal national Australian guidelines as a potentially effective EARLY intervention for reducing the risk of maternal-child outcomes.

Studietype

Intervensjonell

Registrering (Forventet)

5000

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Alberta
      • Stony Plain, Alberta, Canada, T7Z 2M7
        • Westview Health Centre

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

16 år og eldre (Barn, Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

Inclusion criteria:

Pregnant women will be eligible for Phase 2 if they are:

  1. < 28 weeks gestation (to provide the opportunity to complete 6 modules and follow-up questionnaires prior to delivery)
  2. able to speak/read English; and (3) willing to complete email questionnaires

Exclusion Criteria:

  1. >28 weeks gestation
  2. unable to speak/read English
  3. unable to complete email questionnaires

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Screening and CBT
Screening and Cognitive Behavioral Therapy. The intervention group will be screened and if they need criteria they will complete the 6, 30-minute online, interactive CBT modules over 6 weeks.
Cognitive Behavioral Therapy- an effective, non-pharmacological treatment for depression and anxiety.
Ingen inngripen: Usual care
Usual prenatal care

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
The primary outcome of this study is the feasibility/acceptability of integrated psychosocial care and its components.
Tidsramme: 6 weeks post randomization
Feasibility/acceptability of the intervention will be assessed through individual face-to-face or telephone-based semi-structured qualitative interviews of both clinic staff and women in the intervention group. The field does not allow for all questions to be provided. Sample question for clinic staff is 'What aspects made it easy/challenging to use the tablet for prenatal assessment as part of routine prenatal care?' Sample questions for intervention group participants: 1)How did you feel about answering these kinds of questions on a tablet?; 2)Please describe any concerns you had about answering these questions on a tablet; 3)How would you prefer the results to be shared with you
6 weeks post randomization

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Maternal depression, anxiety, stress
Tidsramme: on recruitment, 6 weeks post randomization and 3 months postpartum
Depression, Anxiety, and Stress Scale (DASS-21) Self-reported by mother on emailed questionnaire
on recruitment, 6 weeks post randomization and 3 months postpartum
Maternal coping
Tidsramme: on recruitment, 6 weeks post-randomization and 3 months postpartum
The Brief Cope Self-reported by mother on emailed questionnaire
on recruitment, 6 weeks post-randomization and 3 months postpartum
Relationship Adjustment
Tidsramme: on recruitment, 6 weeks post-randomization and 3 months postpartum
Scale: Dyadic Adjustment Scale, DAS-7 Self-reported by mother on emailed questionnaire
on recruitment, 6 weeks post-randomization and 3 months postpartum
Parenting Stress
Tidsramme: 3 months postpartum
Parenting Stress Scale Self-reported by mother
3 months postpartum
Parenting competence
Tidsramme: 3 months postpartum
Parenting Sense of Competence Scale Self-reported by mother on emailed questionnaire
3 months postpartum
Maternal-infant attachment
Tidsramme: 3 months postpartum
Maternal Attachment Inventory (MAI) Self-reported by mother on emailed questionnaire
3 months postpartum
Trait anxiety
Tidsramme: on recruitment, 6 weeks postrandomization, 3 months postpartum
State Trait Anxiety Inventory (STAI) Self-reported by mother on emailed questionnaire
on recruitment, 6 weeks postrandomization, 3 months postpartum

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Dawn A Kingston, Ph.D, University Of Calgary

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. januar 2014

Primær fullføring (Forventet)

1. desember 2020

Studiet fullført (Forventet)

1. desember 2020

Datoer for studieregistrering

Først innsendt

10. juli 2013

Først innsendt som oppfylte QC-kriteriene

16. juli 2013

Først lagt ut (Anslag)

17. juli 2013

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

13. november 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

11. november 2019

Sist bekreftet

1. november 2019

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 00036912

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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