CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 153 enrolled
Drug / intervention
Video-feedback ODISEA 3.0 +2 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04244318
NCT04244318N/ACompleted

Randomized Clinical Trial to Evaluate the Results of the ODISEA-T Model, in a Sample of Fathers, Mothers and/or Caregivers and Children and Adolescents Belonging to AFT Programs of La Protectora de la Infancia, Chile.

Esteban Gómez Muzzio·interventional·Posted Jan 28, 2020·Updated Feb 20, 2026

In Brief

A clinical study evaluating Video-feedback ODISEA 3.0, ODISEA-DTP: parental therapy, and 1 other intervention for Parent-Child Relations and 2 related conditions. Completed, enrolled 153 participants across 1 site.

Detailed Summary

This is a study protocol of a randomized controlled trial, which aims to validate the effectiveness of the ODISEA Trauma intervention (parental thearpy + videofeedback) compared to a control group. The data collection will be through a three point evaluation (pre, medium and post intervention) using the parenting skills questionnaire (E2P short form), parental stress index - short form (PSI-SF), the adult emotional regulation questionnaire (ERQ), an adult reflective function questionnaire, the parental reflective function questionnaire (PRFQ), the child abuse potential inventory (CAPI), and the socioemotional competence scale for children (ECOS). Additionally, caregivers will be screened for ACES and with a sociodemographic characterization questionnaire. At the same time, profesionals will be assessing caregivers using an scale to measure complex trauma in adults (ECTA). The primary outcome aims to measure the effectiveness of the intervention within the parenting domain (positive parenting practices) and parental trauma (complex trauma, adult emotion regulation, reflective function and child abuse potential of the caregivers). The secondary outcomes will be to assess parenting stress, socioemotional competencies of children and implementation fidelity compared to accumulated risk.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChile
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedJan 28, 2020
Enrollment StartAug 10, 2024
Primary CompletionAug 30, 2025
Study CompletionDec 30, 2025
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 6.4 years ago

Interventions

Video-feedback ODISEA 3.0behavioral

Video-feedback intervention ODISEA 3.0 (Gómez \& Maureira, 2022), which incorporates an attachment theory framework. This intervention was constructed within the ODISEA's comprehensive and formative model of parenthood which was developed in Chile by Dr. Esteban Gómez Muzzio (Gómez, 2022).

ODISEA-DTP: parental therapybehavioral

Parental Therapy (ODISEA-DTP, Gómez \& Maureira, 2022): is a parental therapy strategy that works over 5 sessions with the history of caregivers in a systematic way, allowing to explore their past, present and expected future concerning parenting, child rearing, attachment and child abuse, between other issues. The DTP is a protocolized model of parental therapy, each session is carefully designed to elicit memories, emotions and to stimulate reflective function (about the past and their own childhood) and parental reflective function (about the present with the child).

Treatment as usualbehavioral

Psychosocial intervention (parental education, family counseling, home visits and school and Court coordination) for child abuse and neglect, implemented by six Family Therapeutic Programs (AFT) of the NGO "Protectora de la Infancia"