An Intervention for Enhancing Early Attachment in Primary Health Care

• Register: ClinicalTrials.gov
• Last refreshed on: 17 November 2015
• Main ID: NCT01908881
• Date of registration: 30/05/2013
• Prospective Registration: No
• Primary sponsor: Pontificia Universidad Catolica de Chile
• Public title: An Intervention for Enhancing Early Attachment in Primary Health Care
• Scientific title: Impact of a Group Intervention for Promoting Maternal Sensitivity in Primary Health Care Dyads at Psychosocial Risk. A Randomized Clinical Trial.
• Date of first enrolment: April 2013
• Target sample size: 181
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01908881
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention
• Phase: N/A

Countries of recruitment

Chile

Contacts

• Name: Francisca Figueroa Leigh, MD
• Affiliation: Pontificia Universidad Catolica de Chile

Key inclusion & exclusion 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



Age minimum: N/A
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Child Development

Mother-Child Relations

Intervention(s)

Behavioral: Usual Care

Behavioral: Group Workshop

Primary Outcome(s)

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)]

Secondary Outcome(s)

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)]

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)]

Secondary ID(s)

12-079

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Comisión Nacional de Investigación Científica y Tecnológica