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

11 november 2019 uppdaterad 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.

Studieöversikt

Status

Okänd

Betingelser

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Förväntat)

5000

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

16 år och äldre (Barn, Vuxen, Äldre vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Kvinna

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Inget ingripande: Usual care
Usual prenatal care

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
The primary outcome of this study is the feasibility/acceptability of integrated psychosocial care and its components.
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Maternal depression, anxiety, stress
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 3 months postpartum
Parenting Stress Scale Self-reported by mother
3 months postpartum
Parenting competence
Tidsram: 3 months postpartum
Parenting Sense of Competence Scale Self-reported by mother on emailed questionnaire
3 months postpartum
Maternal-infant attachment
Tidsram: 3 months postpartum
Maternal Attachment Inventory (MAI) Self-reported by mother on emailed questionnaire
3 months postpartum
Trait anxiety
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

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

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 januari 2014

Primärt slutförande (Förväntat)

1 december 2020

Avslutad studie (Förväntat)

1 december 2020

Studieregistreringsdatum

Först inskickad

10 juli 2013

Först inskickad som uppfyllde QC-kriterierna

16 juli 2013

Första postat (Uppskatta)

17 juli 2013

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

13 november 2019

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

11 november 2019

Senast verifierad

1 november 2019

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 00036912

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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