Clinical trial NCT04244318: ODISEA Trauma: Parental Therapy Dispositive + Videofeedback 3.0
Official title: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parent-Child Relations
Parenting
Parent-child Problem
Keywords: video feedback intervention
randomized controlled trial
parenting skills
ODISEA
video-feedback
parental therapy
parental trauma
complex trauma
Lead sponsor: Fundacion America por la Infancia
Sponsor class: OTHER
First posted: 2020-01-28
Enrollment: 215
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: This research is designed as a randomized controlled trial, with 1:1 allocation ratio. The randomization will be performed through block randomization. The participating sites for this study will be 6 family therapeutic programas of ONG "Protectora de la Infancia" in Chile, where the trained professionals are currently working.

1. Specific objectives.

   The primary objective of this research is to determinate the effectiveness of the ODISEA Trauma Intervention (ODISEA-T) in improving parental resilience, strengthening parenting skills and reducing child abuse potential controlled by parental trauma, accumulated risk and parenting stress in caregivers of children aged 0 to 17 years of age, compared to the control group.

   Furthermore, the key secondary objectives are the following:
   1. To measure the effect of ODISEA-T on the pre-post evaluation of parental resilience through the symtoms scale of the adult complex trauma ECTA scale.
   2. To measure the effect of ODISEA-T on a pre-post evaluation of the positive parenting practices using the short form of the E2P scale.
   3. To measure the effect of ODISEA-T on a pre-post evaluation of child abuse potential using the CAPI.
   4. To measure the effect of ODISEA-T on a pre-post evaluation of adult emotion regulation using the ERQ.
   5. To measure the effect of ODISEA-T on a pre-post evaluation of reflective function of caregivers using the RFQ.
   6. To measure the effect of ODISEA-T on a pre-post evaluation of parental reflective function of caregivers using the PRFQ.
   7. To measure the effect of ODISEA-T on a pre-post evaluation of parenting stress levels through the PSI-SF parental stress index - short form.
   8. To measure the effect of ODISEA-T on a pre-post evaluation of children socioemotional competencies through the ECOS scale.
   9. And lastly, to explore the relationship between intervention fidelity and accumulated risk (ACES) and complex trauma (ECTA full scale).
2. Intervention.

Eligible caregivers will be randomized in equal ratio, between three posible conditions: (a) "treatment as usual" control group; (b) ODISEA-T intervention group 1; and (c) ODISEA-T intervention group 2.

The model ODISEA-T consist of a combined 5 sessions of Parental Therapy (ODISEA-DTP: parental therapeutic dispositive) and 5 sessions of Videofeedback (Videofeedback ODISEA 3.0).

* The ODISEA-T intervention group 1 will offer parental therapy followed by videofeedback.
* The ODISEA-T intervention group 2 will offer videofeedback followed by parental therapy.
* The control group, after five months "treatment as usual" intervention, will receive ODISEA-T either way as an ethical consideration.

The ODISEA-DTP: parental therapeutic dispositive (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).

The Video-feedback ODISEA 3.0 (Gómez \& Maureira, 2022) strategy is sequenced in three moments, a) a video recording of the caregiver-child dyad interaction, b) the selection of specific 10-20 seconds interactions sequences which are later discussed by the professional in charge of the dyad, and c) a feedback and reflective process guided by the professional with the caregiver. In this research, the basic five-session Video-feedback ODISEA 3.0 model will be implemented, consisting of (1) a game session recorded on video between the caregiver and the child, (2) followed by a reflective session between the professional and the caregiver, which will be guided using different segments of the video, concentrating on the resources of the caregivers, (3) succeeded by the second recorded game session between the caregiver and the child, (4) continuing with a second reflective session between the caregiver and the professional, integrating more challenging aspects of the interaction, (5) concluding with the last recorded video session of the dyad.

All families assigned to the control group will receive the intervention five months after the pre-test as an ethical decision. Therefore, the comparator will be set as treatment as usual, because all families are participating of a social program focused on cases fo child maltreatment (and cannot be without any kind of intervention).

Considering the counterfactual deliberations from this methodology, for instance the differentiation between the specific's intervention -ODISEA-T- influence against common elements such as the professional's empathy, warmth, listening skills, among others, this elements will be embedded and assessed through a thoughtful fidelity criteria evaluation of the implementation process in order to differentiate the treatment's contributions.

For a given caregiver, the intervention may be needed to be discontinued by the researchers for reasons of withdrawal of the participant consent. Even though there are no risks associated to this intervention, in a rare case of withdrawal because of emotional damage, this will be considered as an adverse event and a protocol has been constructed for managing this situation.

For managing the co-intervention bias, every caregiver will be asked to complete different questions of other interventions that they be considered as concomitant care in addition to the parental therapy + video-feedback intervention that may impact on this trial, such as parenting schools, psychotherapy, among others.

After gathering the sample, an external professional from the NGO "Protectora de la Infancia" will send the folios (not the names) of the cases, and then a research professional through a random numerical assignment will generate a block randomization for the dyads. Once assigned to the control group or experimental group 1 or experimental group 2, the dyads will be given a document that will reinforce what is explained in the informed consent, in informing in which group they been placed, and acknowledging that both groups will have the same intervention.

Due to the characteristics of the intervention and the allocation, neither caregivers nor the professionals will be blinded.

Pre-randomization information will be recorded, regarding the interested caregivers that did not meet all the inclusion criteria, for example not giving their consent. Post-randomization losses will also be recorded.

By August 2024 it is expected a sample of 215 participating dyads from 6 different social programs of NGO "Protectora de la Infancia". Participants will be identified and contacted by the intervention professional, having no relationship with the principal investigator. Their participation is voluntary and has no economic cost to them.

The sample will be recruited through 6 social programs of NGO "Protectora de la Infancia". There will be a participation agreement signed by the directors of the NGO institution participating in this study.

An external professional will proceed to generate the blocked randomization, using a random number generator. When a caregivers agree to participate in the study, the coordinator will give the data to this researcher who till inform the intervention professional the corresponding allocation. All caregivers who gives consent for the study and fulfil the inclusion criteria will be randomized. After the enrollment of each professional, the data will be requested by the study coordinator, which will be assigned to the external researcher to proceed to the randomization.

DATA ANALYSIS

Eight evaluation instruments (ECTA, E2P, CAPI, ERQ, RFQ, PRFQ, PSI-SF, ECOS) will be used as dependent variables.

* ANCOVA will be used to measure the effect of the intervention for each of the different evaluation instruments.
* To explore the relationship between the number of adverse experiences experienced in childhood and the fidelity of the treatment, as well as between complex trauma of the caregivers and the fidelity of treatment, a linear relationship measure between the two variables (simple regression) will be evaluated.
* Measure post-hoc data if the intervention has different effects on each of the dimensions of each instrument (post-hoc ANCOVA).

After proceeding with the data analysis, an outcome research paper will be provided for the scientific community.

DATA MANAGEMENT.

The intervention professionals will provide the gathered data to the research coordinator through two platforms, both password protected: The first platform is https://academia.americaporlainfancia.com/, a website designed to be used as a virtual classroom for the students of America por la Infancia. Therefore, it will be implemented a special section for researches, in which all the intervention professionals will have a username and password to access. In this platform, the different professionals will access the banner associated with this research - which only they can access with their user and personal and non-transferable passwords -, where they will enter the evaluation documents and family data. Only the research coordinator will be able to view and download the documents, and after downloading them they will be stored on the external hard drive that will be stored in the dependencies of Fundación América por la Infancia, being later eliminated from the virtual platform. The hard drive will remain in Los Filósofos 5029, commune of Macul, Santiago, Chile. The second platform is https://wetransfer.com/, a website on which, through the foundation's account, the professionals will send the videos to the coordinator's e-mail, videos that will be sent using a password. This platform allows sending large documents to emails. As the data, the videos will be downloaded, eliminated from the webpage, and stored on the same hard drive mentioned above.

A data monitoring committee (DMC) will not be necessary for this trial, because of the short durations and known minimal risks. Likewise, no interim analyses are considered for this study. Also, as this study is a multicenter trial, auditing will be considered both as an overall process, and for each recruiting center and their professionals, with the objective to monitor consents, completeness, adherence to the protocol, among other relevant data.

No ancillary studies are considered in the implementation of the study. If any tieried consent are constructed for future research unrelated to the this study and for different purposes form the main trial should be sent to the ethics committee and implemented in a protocol amendment.

Eligibility criteria: 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.

Primary outcomes:
measure: Difference of the parental resilience
timeFrame: 5 months.
measure: Difference of the positive parenting practices
timeFrame: 5 months
measure: Difference of child abuse potential
timeFrame: 5 months
Secondary outcomes:
measure: Difference of the adult emotion regulation
timeFrame: 5 months.
measure: Difference of the reflective function of caregivers
timeFrame: 5 months.
measure: Difference of the parental reflective function of caregivers
timeFrame: 5 months.
measure: Difference of parenting stress.
timeFrame: 5 months.
measure: Difference of children´s socioemotional competencies
timeFrame: 5 months.
measure: Difference of the fidelity of the intervention and its association with the accumulated risk of the caregivers.
timeFrame: 5 months.
measure: Difference of the fidelity of the intervention and its association with complex trauma of the caregivers.
timeFrame: 5 months
Other outcomes:
Locations:
city: Santiago de Chile
country: Chile
facility: ONG Protectora de la Infancia
state: Región Metropolitana
Study officials:
affiliation: Executive Director Fundación América por la Infancia
name: Esteban Gómez, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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