ODISEA Trauma: Parental Therapy Dispositive + Videofeedback 3.0

NCT04244318 | Completed DMC

• 1 other identifier: RCT:ODISEA-T
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parent-child Problem; Parent-Child Relations; Parenting

Keywords

video feedback intervention; randomized controlled trial; parenting skills; ODISEA; video-feedback; parental therapy; parental trauma; complex trauma

Outcome Measures

Primary Outcomes (3)

• Difference of the parental resilience

  Parental resilience is defined as a reduction of symptoms associated with complex trauma in the caregivers, assesed using a complex trauma scale in adults (ECTA).

  12 months.

• Difference of the positive parenting practices

  The perception or self-assessment that the adult has regarding their own parenting skills, which will be measured through the E2P short form positive parenting scale (Gómez, Contreras \& Pezora, 2022). E2P is a self-report questionnaire that can be completed by any adult who has a caregiver role of a child between 0 and 17 years old.

  12 months

• Difference of child abuse potential

  Child abuse potential concerns with the risk factors measured by using the Child Abuse Potential Inventory (CAPI, Milner).

  12 months

Secondary Outcomes (7)

• Difference of the adult emotion regulation

  12 months.

• Difference of the reflective function of caregivers

  12 months.

• Difference of the parental reflective function of caregivers

  12 months.

• Difference of parenting stress.

  12 months.

• Difference of children´s socioemotional competencies

  12 months.

Study Arms (3)

G1: DTP + Videofeedback 3.0

EXPERIMENTAL

Once a week, it will be offered a 5-session intervention of parental therapy (DTP). After that, a 5-session intervention of videofeedback. Parental Therapy. S1: the therapist will talk with caregiver about her childhood and attachment figures. S2: family mandates and how they have influenced his life. S3: integration of painful memories and the "inner child". S4: focus on the present time, and rearing. S5: exploring expectations and stimulating a commimment to positive parenting. Videofeedback. S1: a play interaction between the child and the caregiver will be recorded for 10 minutes. S2: will be done between the therapist and caregivers, where they will watch different selected parts of the video and will provide feedback through a mentalization constructed framework. S3: another play interaction video will be recorded, that will be discussed on the S4 with the caregiver. S5: a final interaction video will be recorded.

Behavioral: Video-feedback ODISEA 3.0; Behavioral: ODISEA-DTP: parental therapy

G2: Videofeedback 3.0 + DTP

EXPERIMENTAL

Once a week, it will be offered a 5-session intervention of videofeedback. After that, a 5-session intervention of parental therapy (DTP). Videofeedback. S1: a play interaction between the child and the caregiver will be recorded for 10 minutes. S2: will be done between the therapist and caregivers, where they will watch different selected parts of the video and will provide feedback through a mentalization constructed framework. S3: another play interaction video will be recorded, that will be discussed on the S4 with the caregiver. S5: a final interaction video will be recorded. Parental Therapy. S1: the therapist will talk with caregiver about her childhood and attachment figures. S2: family mandates and how they have influenced his life. S3: integration of painful memories and the "inner child". S4: focus on the present time, and rearing. S5: exploring expectations and stimulating a commimment to positive parenting.

Behavioral: Video-feedback ODISEA 3.0; Behavioral: ODISEA-DTP: parental therapy

Control Group

ACTIVE COMPARATOR

Patients in control group will be placed as an active comparator group, as "treatment as usual" due to the nature of the psychosocial program from wich the cases were selected. After collecting the post-test data, they will be offered the same intervention than the experimental group.

Behavioral: Treatment as usual

Interventions

Video-feedback ODISEA 3.0 BEHAVIORAL

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).

Also known as: videofeedback

G1: DTP + Videofeedback 3.0; G2: Videofeedback 3.0 + DTP

ODISEA-DTP: parental therapy BEHAVIORAL

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).

Also known as: Parental Therapy

G1: DTP + Videofeedback 3.0; G2: Videofeedback 3.0 + DTP

Treatment as usual BEHAVIORAL

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"

Control Group

Eligibility Criteria

• Age: 1 Month - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Ages eligible for study: Caregivers (≥ 18 years), with children between 1 month and 17 years.
• Sexes eligible for study: both.
• Accepts healthy volunteers: yes.

Sponsors & Collaborators

• Esteban Gómez Muzzio: lead

Study Sites (1)

ONG Protectora de la Infancia

Santiago, Santiago Metropolitan, 8150000, Chile

Location

Related Publications (15)

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  PMID: 19272272 BACKGROUND

• Felitti VJ, Anda RF, Nordenberg D, Williamson DF, Spitz AM, Edwards V, Koss MP, Marks JS. Relationship of childhood abuse and household dysfunction to many of the leading causes of death in adults. The Adverse Childhood Experiences (ACE) Study. Am J Prev Med. 1998 May;14(4):245-58. doi: 10.1016/s0749-3797(98)00017-8.

  PMID: 9635069 BACKGROUND

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  PMID: 28784309 BACKGROUND

• Fukkink RG. Video feedback in widescreen: a meta-analysis of family programs. Clin Psychol Rev. 2008 Jul;28(6):904-16. doi: 10.1016/j.cpr.2008.01.003. Epub 2008 Feb 5.

  PMID: 18359136 BACKGROUND

• Juffer F, Struis E, Werner C, Bakermans-Kranenburg MJ. Effective preventive interventions to support parents of young children: Illustrations from the Video-feedback Intervention to promote Positive Parenting and Sensitive Discipline (VIPP-SD). J Prev Interv Community. 2017 Jul-Sep;45(3):202-214. doi: 10.1080/10852352.2016.1198128.

  PMID: 28641060 BACKGROUND

• Juffer F, Bakermans-Kranenburg MJ. Working with Video-feedback Intervention to promote Positive Parenting and Sensitive Discipline (VIPP-SD): A case study. J Clin Psychol. 2018 Aug;74(8):1346-1357. doi: 10.1002/jclp.22645. Epub 2018 May 21.

  PMID: 29781521 BACKGROUND

• Risholm Mothander P, Furmark C, Neander K. Adding "Circle of Security - Parenting" to treatment as usual in three Swedish infant mental health clinics. Effects on parents' internal representations and quality of parent-infant interaction. Scand J Psychol. 2018 Jun;59(3):262-272. doi: 10.1111/sjop.12419. Epub 2017 Dec 15.

  PMID: 29244205 BACKGROUND

• Ramsauer B, Lotzin A, Muhlhan C, Romer G, Nolte T, Fonagy P, Powell B. A randomized controlled trial comparing Circle of Security Intervention and treatment as usual as interventions to increase attachment security in infants of mentally ill mothers: Study Protocol. BMC Psychiatry. 2014 Jan 30;14:24. doi: 10.1186/1471-244X-14-24.

  PMID: 24476106 BACKGROUND

• Schoemaker NK, Jagersma G, Stoltenborgh M, Maras A, Vermeer HJ, Juffer F, Alink LRA. The effectiveness of Video-feedback Intervention to promote Positive Parenting for Foster Care (VIPP-FC): study protocol for a randomized controlled trial. BMC Psychol. 2018 Aug 3;6(1):38. doi: 10.1186/s40359-018-0246-z.

  PMID: 30075813 BACKGROUND

• Suess GJ, Bohlen U, Carlson EA, Spangler G, Frumentia Maier M. Effectiveness of attachment based STEEP intervention in a German high-risk sample. Attach Hum Dev. 2016 Oct;18(5):443-60. doi: 10.1080/14616734.2016.1165265. Epub 2016 Apr 1.

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• Vilaseca R, Rivero M, Bersabe RM, Navarro-Pardo E, Cantero MJ, Ferrer F, Valls Vidal C, Innocenti MS, Roggman L. Spanish Validation of the PICCOLO (Parenting Interactions With Children: Checklist of Observations Linked to Outcomes). Front Psychol. 2019 Mar 27;10:680. doi: 10.3389/fpsyg.2019.00680. eCollection 2019.

  PMID: 30971993 BACKGROUND

• West AL, Aparicio EM, Berlin LJ, Jones Harden B. IMPLEMENTING AN ATTACHMENT-BASED PARENTING INTERVENTION WITHIN HOME-BASED EARLY HEAD START: HOME-VISITORS' PERCEPTIONS AND EXPERIENCES. Infant Ment Health J. 2017 Jul;38(4):514-522. doi: 10.1002/imhj.21654. Epub 2017 Jun 30.

  PMID: 28665540 BACKGROUND

MeSH Terms

Interventions

Therapeutics

Study Officials

• Esteban Gómez, Ph.D.

  Executive Director Fundación América por la Infancia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the characteristics of the intervention and the allocation, neither caregivers nor the professionals will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Phd, Executive Director

Study Record Dates

• First Submitted: January 24, 2020
• First Posted: January 28, 2020
• Study Start: August 10, 2024
• Primary Completion: August 30, 2025
• Study Completion: December 30, 2025
• Last Updated: February 20, 2026

Record last verified: 2026-02

Locations

CL (1)