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Clinical Trials/NCT04267523
NCT04267523
Unknown
N/A

Effectiveness of a Web-based Intervention on Parental Psychological Flexibility and Emotion Regulation

Universidad de Almeria2 sites in 1 country110 target enrollmentDecember 11, 2019
ConditionsParents

Overview

Phase
N/A
Intervention
Not specified
Conditions
Parents
Sponsor
Universidad de Almeria
Enrollment
110
Locations
2
Primary Endpoint
Difficulties Emotion Regulation Scale (DERS: Hervás & Jódar, 2008)
Last Updated
5 years ago

Overview

Brief Summary

This project aims to validate a web-based clinical intervention for families with children suffering neurodevelopmental or behavioral disorders to promote psychological flexibility and emotion regulation strategies in parents.

Detailed Description

Family context, and specifically parents' educational styles (PE) can act as a protective or risk factor for the maintenance and development of various disorders in childhood. When the child is diagnosed of a disease, disorder or difficulty, parents can develop a series of beliefs that will mediate their PEs, their barriers and their emotional repertoire. It can worsen the family climate, lead to maladaptive behaviors, and finally, lead to difficulties in adherence to treatment due to possible avoidance patterns. Several studies indicate that these patterns are mediated by a regulation of dysfunctional emotions in parents by not tolerating the discomfort caused by the suffering of their children. This project aims to validate a web-based clinical intervention for families with children suffering neurodevelopmental or behavioral disorders to promote psychological flexibility and emotion regulation strategies in parents. Clinical intervention is focused in improving emotion regulation and positive parenting strategies using third-wave/contextual therapies. The intervention consist in 6 sessions with a duration of 1.5 hours. This study compare a a face-to-face parenting intervention group with a web-based parenting intervention. The first hypothesis is that both parental interventions will improve the educational styles, emotional competencies and well-being of parents in pos-test and 3-month follow up assessment. Second, web-based intervention will be more efficient in comparison with face-to-face intervention.

Registry
clinicaltrials.gov
Start Date
December 11, 2019
End Date
May 5, 2024
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Juan Miguel Flujas

Principal Investigator

Universidad de Almeria

Eligibility Criteria

Inclusion Criteria

  • A. Be a parent/guardian of a child between 0 and 12 years old. B. Be a parent/guardian of a child who obtains a limit score on any of the scales of the Difficulties and Capabilities Questionnaire (SDQ).
  • C. Obtain a high score in parental inflexibility / emotional distress through the Parental Acceptance Questionnaire in any of its subscales.
  • D. Parents/guardians have a device that provides access to the web-based intervention.
  • E. They agree to participate in the study by signing the informed consent

Exclusion Criteria

  • A. The parent/guardian is in a process of separation or negligent parenting, this aspect will be assessed from a clinical trial in the initial interview.
  • B. The parent/guardian has serious psychological or substance use problems or disorders that may hinder their participation in the study.
  • C. The parent/guardian presents Spanish comprehension barriers.

Outcomes

Primary Outcomes

Difficulties Emotion Regulation Scale (DERS: Hervás & Jódar, 2008)

Time Frame: Change from baseline at immediately after the intervention, and at 3 months

To assess the emotional regulation of parents. It consists of 28 items that make up 5 dimensions of emotional deregulation: lack of control, rejection, interference, neglect and confusion. The reliability index (Cronbach's alpha) is between .87 and .93

Parental Stress Scale (PSS; Alonso-Arbiol y Balluerka, 2007)

Time Frame: Change from baseline at immediately after the intervention, and at 3 months

To assess the level of parental stress. It consists of 20 items that evaluate positive and negative experiences. The scale has a reliability of .77 and .76

Parental Acceptance Questionnaire (Flujas-Contreras, García-Palacios, & Gómez, 2018)

Time Frame: Change from baseline at immediately after the intervention, and at 3 months

To assess Measures psychological flexibility in parents regarding the interaction with their children through 3 dimensions: open, aware and active. Spanish version has internal consistency of .82

Secondary Outcomes

  • Satisfaction with Life Scale (SWLS; Atienza, Pons, Balaguer, & García-Merita, 2000)(Change from baseline at immediately after the intervention months, and at 3 months)
  • Strength and Difficulties Questionnaire, (SDQ; Gómez-Beneyto et al., 2012)(Change from baseline at immediately after the intervention, and at 3 months)

Study Sites (2)

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