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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 153
- Locations
- 1
- Primary Endpoint
- Difference of the parental resilience
Study Overview
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 9 family therapeutic programas of ONG "Protectora de la Infancia" in Chile, where the trained professionals are currently working.
- 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:
- 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.
- 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.
- To measure the effect of ODISEA-T on a pre-post evaluation of child abuse potential using the CAPI.
- To measure the effect of ODISEA-T on a pre-post evaluation of adult emotion regulation using the ERQ.
- To measure the effect of ODISEA-T on a pre-post evaluation of parental reflective function of caregivers using the PRFQ.
- 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.
- To measure the effect of ODISEA-T on a pre-post evaluation of children socioemotional competencies through the ECOS scale.
- And lastly, to explore the relationship between intervention fidelity and accumulated risk (ACES) and complex trauma (ECTA full scale).
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
Due to the characteristics of the intervention and the allocation, neither caregivers nor the professionals will be blinded.
Eligibility Criteria
- Ages
- 1 Month to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
G1: DTP + Videofeedback 3.0
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.
Intervention: Video-feedback ODISEA 3.0 (Behavioral)
G1: DTP + Videofeedback 3.0
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.
Intervention: ODISEA-DTP: parental therapy (Behavioral)
G2: Videofeedback 3.0 + DTP
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.
Intervention: Video-feedback ODISEA 3.0 (Behavioral)
G2: Videofeedback 3.0 + DTP
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.
Intervention: ODISEA-DTP: parental therapy (Behavioral)
Control Group
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.
Intervention: Treatment as usual (Behavioral)
Outcomes
Primary Outcomes
Difference of the parental resilience
Time Frame: 12 months.
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).
Difference of the positive parenting practices
Time Frame: 12 months
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.
Difference of child abuse potential
Time Frame: 12 months
Child abuse potential concerns with the risk factors measured by using the Child Abuse Potential Inventory (CAPI, Milner).
Secondary Outcomes
- 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.)
- Difference of the fidelity of the intervention and its association with the accumulated risk of the caregivers.(12 months.)
- Difference of the fidelity of the intervention and its association with complex trauma of the caregivers.(12 months)
Investigators
Esteban Gómez Muzzio
Phd, Executive Director
Fundacion America por la Infancia