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

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.

Study Overview

• Status: Recruiting
• Conditions: Parents
• Intervention / Treatment: Behavioral: Web parenting intervention; Behavioral: Group parenting intervention

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 Type: Interventional
• Enrollment (Anticipated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Juan M. Flujas-Contreras, MD; Phone Number: +34 674 596 371; Email: jfc397@ual.es
• Study Contact Backup: Name: Inmaculada Gomez, Prf.; Phone Number: +34 950 214414; Email: igomez@ual.es

Study Locations

• Spain
  • Almeria
    • Almería, Almeria, Spain, 04120
      • Recruiting
      • University of Almería
      • Contact: Juan M Flujas-Contreras, MD; Phone Number: 674 596 371; Email: jfc397@ual.es
      • Principal Investigator: Inmaculada Gómez, Dr.
  • Castellón
    • Castellón De La Plana, Castellón, Spain, 12071
      • Recruiting
      • University Jaume I
      • Contact: Azucena García Palacios, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Web-based 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.	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.
ACTIVE_COMPARATOR: Face-to-face 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Universidad de Almeria
• Collaborators: Universitat Jaume I
• Investigators: Study Director: Inmaculada Gomez, Prof., University de Almeria; Study Director: Azucena Garcia-Palacios, Prof., University Jaume I

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 11, 2019
• Primary Completion (ANTICIPATED): December 30, 2023
• Study Completion (ANTICIPATED): May 5, 2024

Study Registration Dates

• First Submitted: December 10, 2019
• First Submitted That Met QC Criteria: February 11, 2020
• First Posted (ACTUAL): February 13, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 30, 2021
• Last Update Submitted That Met QC Criteria: April 29, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Web-based intervention; Parenting; Emotion regulation; Psychological flexibility; Third-wave therapies
• Other Study ID Numbers: PSY001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data will be available after deidentification.
• IPD Sharing Time Frame: The duration of the study
• IPD Sharing Access Criteria: Not decided
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No