An Intervention for Enhancing Early Attachment in Primary Health Care

NCT01908881 | Completed

• 1 other identifier: 12-079
• Study Type: interventional
• Target: 181
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Child Development; Mother-Child Relations

Keywords

Child Development; Mother-Child relations; Primary Health Care; Public Policy

Outcome Measures

Primary Outcomes (1)

• 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)

  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.

  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)

Secondary Outcomes (2)

• Difference in the total score of the parental sensitivity scale (of the CARE-Index Scale) before and after the study in both groups

  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)

• Difference in the percentage of dyads that have a positive Edinburgh postnatal depression scales (≥10 points) before and after the study in both groups

  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)

Study Arms (2)

Control (usual care)

ACTIVE COMPARATOR

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

Intervention (group workshop+usual care)

EXPERIMENTAL

Group intervention (group workshop) described elsewhere

Behavioral: Group Workshop; Behavioral: Usual Care

Interventions

Group Workshop BEHAVIORAL

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.

Also known as: Group intervention

Intervention (group workshop+usual care)

Usual Care BEHAVIORAL

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.

Control (usual care); Intervention (group workshop+usual care)

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead
• Comisión Nacional de Investigación Científica y Tecnológica: collaborator

Study Sites (2)

Centro de Salud Familiar El Roble

Santiago, Santiago Metropolitan, 8820814, Chile

Location

ANCORA Centro de Salud Familiar Juan Pablo II

Santiago, Santiago Metropolitan, 8831695, Chile

Location

Study Officials

• Francisca Figueroa Leigh, MD

  Pontificia Universidad Catolica de Chile

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2013
• First Posted: July 26, 2013
• Study Start: April 1, 2013
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: November 4, 2015

Record last verified: 2015-11

Locations

CL (2)