Video Feedback to Improve Parental Sensitivity in Mother-infant Dyads With Depressive Symptoms

NCT04748731 | Completed DMC

• 1 other identifier: VF and mentalizing
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

Title: "Internet mentalization-based video feedback intervention to improve parental sensitivity in mother-infant dyads with maternal depressive symptoms: randomized controlled feasibility trial". Funding: ANID Millennium Science Initiative /Millennium Institute for Research on Depression and Personality-MIDAP ICS13\_005 (MIDAP, www.midap.org). Principal Investigator: Marcia Olhaberry Huber, PhD, Academic, School of Psychology, Pontificia Universidad Católica de Chile, Associate Researcher, MIDAP. MIDAP Research Team: Javier Moran, PhD. Academic at the University of Valparaíso, María José León, PhD, Stefanella Costa, PhD. and Fanny Leyton, PhD. (c) University of Valparaíso. General Objective: To evaluate feasibility and acceptability of a brief Internet mentalization-based video feedback intervention to improve sensitivity in mothers with depressive symptoms. Key parameters for a future effectiveness study will be identified Design: Pilot randomized clinical trial; Participants: 60 mother-infant dyads (aged 4-12 months) attended in Public Health Centres.30 dyads will be assigned to the experimental group (EG) and will receive a weekly online brief intervention using video-feedback and psycho-educational materials on early parenting. 30 dyads will be assigned to the control group (CG) and will receive only psycho-educational materials. The study includes 3 assessments (pre-intervention, post-intervention and follow-up) and four weekly intervention sessions. Data analysis: For quantitative data descriptive statistics and ANCOVA will be used, for qualitative data Grounded Theory.

Conditions

Parent-Child Relations; Depressive Symptoms

Outcome Measures

Primary Outcomes (1)

• Change in Maternal sensitivity

  Emotional Availability Scale (EAS). Scores range from 0 to 10o with higher scores indicating higher emotional availability. Therefore, higher scores mean better outcomes.

  before the intervention; through study completion, an average of 1 year; and a 3 months follow-up.

Secondary Outcomes (5)

• Change in Parental Reflective Functioning

  before the intervention; through study completion, an average of 1 year; and a 3 months follow-up.

• Change in Maternal Depressive Symptoms Measured with EPDS

  before the intervention; through study completion, an average of 1 year; and a 3 months follow-up.

• Change in Maternal Depressive Symptoms Measured with CORE OM

  before the intervention; through study completion, an average of 1 year; and a 3 months follow-up.

• Change in Maternal Depressive Symptoms Measured with PHQ 9

  before the intervention; through study completion, an average of 1 year; and a 3 months follow-up.

• Change in Children Socio Emotional Development

  before the intervention; through study completion, an average of 1 year; and a 3 months follow-up.

Other Outcomes (3)

• Feasibility of the intervention

  Through study completion, approximately 18 months

• Intervention's acceptability by credibility/expectancy rates

  Through study completion, approximately 18 months

• Intervention's acceptability by participant's experience

  Through study completion, approximately 18 months

Study Arms (2)

Experimental Group. Video-feedback intervention.

EXPERIMENTAL

A weekly online brief intervention using video-feedback and psycho-educational materials on early parenting (detailed description of the intervention on section 5).

Behavioral: Internet mentalization-based video feedback intervention to improve parental sensitivity in mother-infant dyads with maternal depressive symptoms

Control Group. Psycho-educational intervention

OTHER

They will receive weekly information on parenting in the 1st year of life. They will have direct contact (via WhatsApp) with a child psychologist to ask questions about the material and to refer to specialized support if needed.

Behavioral: Psycho-Educational Intervention

Interventions

Internet mentalization-based video feedback intervention to improve parental sensitivity in mother-infant dyads with maternal depressive symptoms BEHAVIORAL

a weekly online brief intervention using video-feedback and psycho-educational materials on early parenting

Experimental Group. Video-feedback intervention.

Psycho-Educational Intervention BEHAVIORAL

Reception of psycho-educational materials

Control Group. Psycho-educational intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mother must be over 18 years old
• Mother must have a 4 to 12 months infant
• Mother must be a user of primary public health
• Mother must score at least 5 points in the EPDS during routine health controls in health centres

You may not qualify if:

• Mothers presenting severe intellectual deficit or psychotic symptoms.
• Infants presenting developmental disorders and/or at high risk of abuse or neglect

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead
• Instituto Milenio para Investigación en Depresión y Personalidad: collaborator

Study Sites (1)

CESFAM Puerto Varas

Puerto Varas, Los Lagos Region, Chile

Location

Related Publications (1)

• Olhaberry M, Leyton F, Moran-Kneer J, Leon MJ, Sieverson C, Muzard A, Honorato C, Ensink K, Malberg N, Luyten P, Costa-Cordella S. Strength-based Video-feedback to improve maternal sensitivity in mother-infant dyads with maternal depressive symptoms: Study protocol for a randomized controlled feasibility trial. Medwave. 2022 Dec 15;22(11):e2570. doi: 10.5867/medwave.2022.11.2570. English, Spanish.

  PMID: 36583684 DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Design

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

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: February 10, 2021
• Study Start: March 1, 2021
• Primary Completion: January 25, 2022
• Study Completion: January 25, 2022
• Last Updated: June 16, 2022

Record last verified: 2021-01

Locations

CL (1)