CompletedNot Applicable

ODISEA Trauma: Parental Therapy Dispositive + Videofeedback 3.0

Chile153 participantsStarted 2024-08-10

Plain-language 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.

Who can participate

Age range

1 Month – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Ages eligible for study: Caregivers (≥ 18 years), with children between 1 month and 17 years. * Sexes eligible for study: both. * Accepts healthy volunteers: yes. * Inclusion criteria for the adult: adult caregiver (≥ 18 years), mother, father or other caregiver of children between 1 month and 17 years * Inclusion criteria for the child: Age between 1 month and 17 years. Exclusion Criteria: * Exclusion criteria for the adult: Court order which denies the adult to be with the child. * Exclusion criteria for the child: No exclusion criteria.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Difference of the parental resilience

Timeframe: 12 months.

Difference of the positive parenting practices

Timeframe: 12 months

Difference of child abuse potential

Timeframe: 12 months

Trial details

NCT IDNCT04244318

SponsorEsteban Gómez Muzzio

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-08-30

View on ClinicalTrials.gov More Parent-Child Relations trials