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

Parents Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04267523
• Other study ID #: Psy001
• Status: Recruiting
• Phase: N/A
• Start date: December 11, 2019
• Est. completion date: May 5, 2024

Study information

• Verified date: April 2021
• Source: Universidad de Almeria
• Contact: Juan M. Flujas-Contreras, MD
• Phone: +34 674 596 371
• Email: jfc397[@]ual.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: May 5, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Parents

Intervention

Behavioral:
• Web parenting intervention
Parents participate in the self-delivered web-based parenting intervention for 6 modules. Treatment includes abilities of psychological flexibility (to be open, aware and active), emotion regulation, and positive parenting strategies.
• Group parenting intervention
Parents participate in face-to-face a weekly 2-hour group for 4 sessions. Treatment includes abilities of psychological flexibility (to be open, aware and active), emotion regulation, and positive parenting strategies.

Locations

Country	Name	City	State
Spain	University of Almería	Almería	Almeria
Spain	University Jaume I	Castellón De La Plana	Castellón

Sponsors (2)

Lead Sponsor	Collaborator
Universidad de Almeria	Universitat Jaume I

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Client Satisfaction Questionnaire (Hidalgo y cols., 2013)	It consists of 8 items on a 4-point Likert scale that assesses satisfaction in a one-dimensional way	Immediately after the intervention
Other	Parental coping and mood	The current mood and the perception of coping capacity will be assessed pre and post session through two questions that measure mood by means of visual scale of faces (Likert of 5 points) and coping by Likert scale of 5 points	Change from baseline at immediately after the intervention
Primary	Parental Acceptance Questionnaire (Flujas-Contreras, García-Palacios, & Gómez, 2018)	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	Change from baseline at immediately after the intervention, and at 3 months
Primary	Difficulties Emotion Regulation Scale (DERS: Hervás & Jódar, 2008)	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	Change from baseline at immediately after the intervention, and at 3 months
Primary	Parental Stress Scale (PSS; Alonso-Arbiol y Balluerka, 2007)	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	Change from baseline at immediately after the intervention, and at 3 months
Secondary	Satisfaction with Life Scale (SWLS; Atienza, Pons, Balaguer, & García-Merita, 2000)	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	Change from baseline at immediately after the intervention months, and at 3 months
Secondary	Strength and Difficulties Questionnaire, (SDQ; Gómez-Beneyto et al., 2012)	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	Change from baseline at immediately after the intervention, and at 3 months