An Intervention for Enhancing Early Attachment in Primary Health Care

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Pontificia Universidad Catolica de Chile
Sponsor:
Collaborator:
Comisión Nacional de Investigación Científica y Tecnológica
Information provided by (Responsible Party):
Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier:
NCT01908881
First received: May 30, 2013
Last updated: July 23, 2013
Last verified: July 2013
  Purpose

The purpose of this study is to determine whether a group intervention for primary health care dyads (two interacting people, in this case: mother-infant or caregiver-infant), which have been screened during pregnancy to be at psychosocial risk, has an impact on parental sensitivity.


Condition Intervention
Child Development
Mother-Child Relations
Behavioral: Group Workshop
Behavioral: Usual Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Impact of a Group Intervention for Promoting Maternal Sensitivity in Primary Health Care Dyads at Psychosocial Risk. A Randomized Clinical Trial.

Resource links provided by NLM:


Further study details as provided by Pontificia Universidad Catolica de Chile:

Primary Outcome Measures:
  • Percentage of dyads that change their category from "Interactional risk" (according to a score of ≤ 6 points in parental sensitivity in the CARE-Index Scale) to category of "Non interactional risk" (score of ≥ 7 points) [ Time Frame: To be measured at: enrollment (when the interview is done), immediately after participating in the group workshop (from 1 to 2 weeks after the workshop is finished) and 4 months after (measuring times are also for control group) ] [ Designated as safety issue: No ]

    The CARE-Index Scale is a validated method for the evaluation of dyadic interaction through observation and microanalysis (using a video of 3 minute play between the child and caregiver) scored by a trained expert coder. It generates a score in terms of parental sensitivity (or maternal sensitivity) on a scale of 1 to 14 (supposing better sensitivity with higher scores) and another cut off punctuation score for the classification of 2 categories:

    • "Interactional risk": 6 or less points on the parental sensitivity scale, which suggests that the dyad should be intervened
    • "Non interactional risk": 7 or more points on the parental sensitivity scale.


Secondary Outcome Measures:
  • Difference in the total score of the parental sensitivity scale (of the CARE-Index Scale) before and after the study in both groups [ Time Frame: To be measured at: enrollment (when the interview is done), immediately after participating in the group workshop (from 1 to 2 weeks after the workshop is finished) and 4 months after (measuring times are also for control group) ] [ Designated as safety issue: No ]
  • Difference in the percentage of dyads that have a positive Edinburgh postnatal depression scales (≥10 points) before and after the study in both groups [ Time Frame: To be measured at: enrollment (when the interview is done), immediately after participating in the group workshop (from 1 to 2 weeks after the workshop is finished) and 4 months after (measuring times are also for control group) ] [ Designated as safety issue: No ]
    The presence of depressive symptoms in the mother or caregiver will be measured given the effect of postpartum depression on the emotional availability of the mother and her capacity to respond sensibly to the child's needs. This will be done through the Edinburgh postnatal depression scale, which is an instrument used widely in Primary Health Care for screening for postpartum depression. It consists in an auto-administered questionnaire, with 10 multiple choice questions (the higher the score, more depressive symptoms). It has been validated in Chile, and using a cutoff point of 9/10 it has proven to have a 100% sensibility and 80% specificity.


Estimated Enrollment: 188
Study Start Date: April 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control (usual care)
This arm receives usual care ("control group") consisting in: home visits, evaluation by social worker and planning interventions according to multidisciplinary team usually done en Family Primary Health Care Centers
Behavioral: Usual Care
According to the screening carried out various interventions are offered by Primary Health Care centers (eg. home visits) in the "Chile Crece Contigo" Program. During pregnancy, if the mother is screened for positive psychosocial risk she would receive different interventions consisting in (usual care at Primary Health Care Centers): home visits, evaluation by social worker and planning interventions according to a multidisciplinary team.
Other Name: Usual care
Experimental: Intervention (group workshop+usual care)
Group intervention (group workshop) described elsewhere
Behavioral: Group Workshop
The intervention consists in a group workshop (for up to 7 dyads with children aged between 6 and 12 months and two health care professional monitors) of four sessions of two hours each, held weekly. One of the sessions is characterized as including the fathers or other caregivers relevant to the upbringing of the children. Each session is structured around various activities that specifically deal with the skills associated with parental sensitivity and address relevant issues to child rearing, considering the development of the child.
Other Name: Group intervention
Behavioral: Usual Care
According to the screening carried out various interventions are offered by Primary Health Care centers (eg. home visits) in the "Chile Crece Contigo" Program. During pregnancy, if the mother is screened for positive psychosocial risk she would receive different interventions consisting in (usual care at Primary Health Care Centers): home visits, evaluation by social worker and planning interventions according to a multidisciplinary team.
Other Name: Usual care

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Dyad with the child aged 4-12 months old
  • Have screened positive for 1 or more psychosocial risks during pregnancy

Exclusion Criteria:

  • Mother or caregiver with severe mental health disorder, specifically: schizophrenia, mental retardation and severe mood disorders with active suicidal ideas
  • Child with important biomedical problems, specifically: genetic syndromes, severe heart disease and extreme preterm birth
  • Severe psychosocial problems, specifically: previous history of child abuse or institutionalization of other children from the family
  • Not signing the Informed Consent Form
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01908881

Contacts
Contact: Francisca Figueroa Leigh, MD 56-2-23548535 ext 8535 ffiguerl@uc.cl
Contact: Victoria Binda, MD 6-2-23548535 ext 8535 victoria.binda@gmail.com

Locations
Chile
Centro de Salud Familiar El Roble Recruiting
Santiago, Region Metropolitana, Chile, 8820814
Contact: Victoria Binda, MD    56-2-23548535 ext 8535    victoria.binda@gmail.com   
Principal Investigator: Victoria Binda, MD         
ANCORA Centro de Salud Familiar Juan Pablo II Recruiting
Santiago, Región Metropolitana, Chile, 8831695
Contact: Francisca Figueroa Leigh, MD    56-2-23548535 ext 8535    ffiguerl@uc.cl   
Principal Investigator: Francisca Figueroa Leigh, MD         
Sponsors and Collaborators
Pontificia Universidad Catolica de Chile
Comisión Nacional de Investigación Científica y Tecnológica
Investigators
Principal Investigator: Francisca Figueroa Leigh, MD Pontificia Universidad Catolica de Chile
  More Information

No publications provided

Responsible Party: Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier: NCT01908881     History of Changes
Other Study ID Numbers: 12-079
Study First Received: May 30, 2013
Last Updated: July 23, 2013
Health Authority: Chile: Pontificia Universidad Catolica de Chile
Chile: Comisión Nacional de Investigación Científica y Tecnológica

Keywords provided by Pontificia Universidad Catolica de Chile:
Child Development
Mother-Child relations
Primary Health Care
Public Policy

ClinicalTrials.gov processed this record on October 23, 2014