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

Not Applicable

• Conditions: Parents
• Interventions: Behavioral: Web parenting intervention; Behavioral: Group parenting intervention

• Registration Number: NCT04267523
• Lead Sponsor: Universidad de Almeria

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.

Study Timeline

• Study First Submitted: 2019-12-10
• Study Start: 2019-12-11
• Study First Submitted QC: 2020-02-11
• Study First Posted: 2020-02-13
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-29
• Last Update Posted: 2021-04-30
• Primary Completion: 2023-12-30
• Study Completion: 2024-05-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 110

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Web-based parenting intervention	Web parenting intervention	Families randomized to this intervention group will receive a self-administered web-based parenting intervention. Parents have access to a weekly 6-modules parenting intervention.
Face-to-face parenting intervention	Group parenting intervention	Families randomized to this intervention group will receive a face-to-face group parenting intervention. Groups will meet weekly for 120 minutes for 4 weeks.

Primary Outcome Measures

Name	Time	Method
Difficulties Emotion Regulation Scale (DERS: Hervás & Jódar, 2008)	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)	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)	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 Outcome Measures

Name	Time	Method
Satisfaction with Life Scale (SWLS; Atienza, Pons, Balaguer, & García-Merita, 2000)	Change from baseline at immediately after the intervention months, and at 3 months	to assess the overall satisfaction of parents as a one-dimensional construct, it consists of 5 items that are answered on a Likert scale of 1 to 7; the Spanish version has provided reliability indexes of .84
Strength and Difficulties Questionnaire, (SDQ; Gómez-Beneyto et al., 2012)	Change from baseline at immediately after the intervention, and at 3 months	In order to evaluate the effects of the intervention on the behavior of the children, behavioral changes in difficulties, emotional symptoms, behavioral problems, hyperactivity problems, problems with partners and prosocial actions

Trial Locations

Locations (2)

University Jaume I; 🇪🇸 Castellón De La Plana, Castellón, Spain

University of Almería; 🇪🇸 Almería, Almeria, Spain