ODISEA 2.0 Video-feedback Intervention to Promote Parenting Skills

Study Overview
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Brief Summary
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This is a study protocol of a randomized controlled trial, which aims to validate the effectiveness of the ODISEA 2.0 Video-feedback intervention compared to a non-intervention group. While this methodology can be used with caregivers of children from 0 to 8 years, in this first study the sample will be caregivers and children from 10 to 47 months. The data collection will be through a pre post evaluation using the parenting skills questionnaire (E2P V2), parental stress index - short form (PSI-SF), and assessment of interaction videos with the Adult Sensitivity Scale (E.S.A) and PICCOLO methodology. Additionally, caregivers will be screened for ACES and with a sociodemographic characterization questionnaire. The primary outcome aims to measure the effectiveness of the intervention within the parenting skills of the caregivers. The secondary outcomes will be to assess parental self-efficacy, parenting stress, parenting practices, parental sensitivity, and implementation fidelity compared to accumulated risk.

Detailed Description
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This research is designed as a randomized controlled trial, with 1:1 allocation ratio. The randomization will be performed through block randomization. For the study setting, to extend the generalizability of the intervention results, the participating sites for this study will be various cities along Chile, therefore having urban and rural situations, collecting data through different social programs where the trained professionals are currently working. Specific objectives. The primary objective of this research is to determinate the effectiveness of the basic ODISEA 2.0 Video-feedback intervention in strengthening parenting skills controlled by accumulated risk and parenting stress in caregivers of children aged 10 to 47 months compared to the control group. Furthermore, the key secondary objectives are the following: Firstly, to measure the effect of ODISEA 2.0 video-feedback on the pre-post evaluation of parental self-efficacy through the E2P positive parenting scale. Secondly, to measure the effect of ODISEA 2.0 video-feedback on a pre-post evaluation of the parenting stress levels through the PSI-SF parental stress index - short form. Thirdly, to measure the effect of ODISEA 2.0 video feedback intervention on pre-post positive parenting behaviors evaluation through the Piccolo scale. Fourthly, to measure the effect of ODISEA 2.0 video-feedback intervention on pre-post parental sensitivity evaluation through the adult sensitivity scale E.S.A. And lastly, to explore the relationship between intervention fidelity and accumulated risk (ACES). Intervention. Eligible caregivers will be randomized in equal ratio, between 5 sessions of ODISEA 2.0 Video-feedback and a nonintervention control group. The control group, after two months without intervention, will receive it either way as an ethical consideration. The ODISEA 2.0 Video-feedback strategy is sequenced in three moments, a) a video recording of the caregiver-child dyad interaction, b) the selection of specific 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 ODISEA 2.0 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 two months after the pre-test as an ethical decision. Therefore, the comparator will be set as untreated, assigning the families as a non-intervention control group. Being this research the first RCT study where the ODISEA Video-feedback 2.0 methodology will be applied, the rationale for this decision is to assess whether the families receiving this intervention will benefit in comparison of people that do not. Considering the counterfactual deliberations from this methodology, for instance the differentiation between the specific's intervention -ODISEA Video-feedback 2.0- 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 video-feedback intervention that may impact on this trial, such as parenting schools, psychotherapy, among others. After gathering the sample, an external research professional, through a random numerical assignment will generate a block randomization for the dyads. Once assigned to the control group or experimental group, 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. This document is named The road that we will travel, and there will be a different format for each group. Due to the characteristics of the intervention and the allocation, neither caregivers nor the professionals will be blinded, nevertheless the encoders of PICCOLO and E.S.A will be masked, considered as an outcome assessor masking procedure. They will be external researchers of this study. No emergency unblinding procedures were created, because only the external decoders will be masked. However, in the analysis stage that is typified in the following diagram, the professionals will have to analyze the videos will be masked, not knowing if they are pre or post intervention videos. 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 July 2020 it is expected a sample of 100 participating dyads from different regions of the country. 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. For the control group an economic remuneration of $ 10,000 chilean pesos will be delivered after concluding the two months on nonintervention, being a retention strategy for capturing the post evaluation data of this group. The sample will be recruited through social networks in the media of Fundación América por la Infancia, and through specific strategies of the intervention professionals who will participate in the study, adapting to their local realities where they practice their profession, such as hospitals and mental health services. There will be a participation agreement signed by the directors of the different institutions that will participate 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 Parenting skills will be measured through four evaluation instruments that 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, 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 Providencia 201, fourth floor, commune of Providencia, 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. The principal investigator, Dr. Gómez, and the co-investigator, M.D. Maureira will be given access to the cleaned data sets. The study coordinator, M.D. Gabriel will retrieve the password protected data sets, having access to the multi-center data that will be housed on the Academia America por la Infancia Web site. 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.

Official Title
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Randomized Controlled Trial for the Effect of ODISEA 2.0 Video-feedback Intervention in Promoting Parenting Skills in Caregivers of Children Between 10 and 47 Months

Conditions
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Parent-Child Relations, Parenting, Parent-child Problem

Intervention / Treatment
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* Behavioral: Video-feedback ODISEA 2.0


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages eligible for study: Caregivers (≥ 18 years), with children between 10 and 47 months. 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 10 and 47 months Inclusion criteria for the child: Age between 10 and 47 months. 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.

Ages Eligible for Study
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Minimum Age: 10 Months
Maximum Age: 47 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Video Feedback ODISEA 2.0.<br>Once a week, the 5 session intervention of Video-feedback ODISEA 2.0 will be done with the family. In the first session, a play interaction between the child and the caregiver will be recorded for 10 minutes. The second session 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. Then, in the third session another play interaction video will be recorded, that will be discussed on the fourth session with the caregiver. Finally, in the fifth session a final interaction video will be recorded. | Behavioral: Video-feedback ODISEA 2.0<br>* Video-feedback intervention which ODISEA 2.0 (Gómez & Maureira, 2017), 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.<br>|
| No Intervention: Control Group.<br>Patients in control group will be placed as a non intervention group. After collecting the post-test data, they will be offered the same intervention than the experimental group. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of the basic ODISEA 2.0 Video-feedback intervention in strengthening parenting skills. | Complex construct which implies different aspects of parenting, such as behaviors, attitude, and involves not only the relationship with the child but also the wellbeing of the adult. | 2 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference of the parenting self-efficacy. | The perception or self-assessment that the adult has regarding their own parenting skills, which will be measured through the E2P V.2 positive parenting scale (Gómez & Contreras , 2019). E2P V2 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. | 2 months. | 
| Difference of parenting stress. | Defined as a complex construct that combines characteristics of the caregivers, of the child and of the family, and how they interact to the person's evaluation of their role as caregiver (Abidin 1992, in Mc Kelvey et al 2008). Will be assessed through the PSI-SF. | 2 months. | 
| Difference of the parenting behaviors. | Defined as parental interactions that predict a positive development of social, cognitive and language skills (Roggman et al., 2013), which will be measured through the Parenting Interactions with Children: Checklist of Observations Linked to Outcomes, PICCOLO. | 2 months. | 
| Difference of the parenting sensitivity. | Defined as the capacity of the caregiver to read the child's communicative signals, interpret them appropriately and offer an adequate, timely and contingent response. This will be measured through the E.S.A scale, an observational instrument that evaluates the caregivers' behaviors with children between six months to four years. These behaviors are assessed by 19 indicators that are categorized between 1, 2 and 3, which will evaluate sensitivity in different components (Santélices et al, 2012). | 2 months. | 
| Difference of the fidelity of the intervention and its association with the accumulated risk of the caregivers. | Accumulated risk was constructed incorporating the ACES (adverse childhood experiences) screening scale. By screening the adverse experiences that the caregiver had experienced in his or her childhood, it will be able to assign it in different complexity levels. According to the longitudinal study of adverse childhood experiences, 10 categories were defined that refer to high stress events that occur between 0 and 18 years of age (Felliti & Anda, 1998). | 2 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Video Feedback intervention, randomized controlled trial, parenting skills, ODISEA, video-feedback