Parenting Clinical Trial
Official title:
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
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.
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | December 30, 2021 |
Est. primary completion date | December 30, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 10 Months to 47 Months |
Eligibility | 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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Esteban Gómez Muzzio |
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* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
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Primary | 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 | 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. | |
Secondary | 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. | |
Secondary | 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. | |
Secondary | 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. | |
Secondary | 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. |
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