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

NCT ID: NCT04267523

Last Updated: 2021-04-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-11
• Study Completion Date: 2024-05-05

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.

Conditions

Parents

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Web parenting intervention

Intervention Type: BEHAVIORAL

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.

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.

Group Type: ACTIVE_COMPARATOR

Group parenting intervention

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universitat Jaume I

OTHER

Sponsor Role: collaborator

Universidad de Almeria

OTHER

Sponsor Role: lead

Responsible Party

Juan Miguel Flujas

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Inmaculada Gomez, Prof.

Role: STUDY_DIRECTOR

University de Almeria

Azucena Garcia-Palacios, Prof.

Role: STUDY_DIRECTOR

University Jaume I

Locations

University of Almería

Almería, Almeria, Spain

Site Status: RECRUITING

University Jaume I

Castellon, Castellón, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Juan M. Flujas-Contreras, MD

Role: CONTACT

jfc397@ual.es

+34 674 596 371

Inmaculada Gomez, Prf.

Role: CONTACT

igomez@ual.es

+34 950 214414

Facility Contacts

Juan M Flujas-Contreras, MD

Role: primary

jfc397@ual.es

674 596 371

Azucena García Palacios, Dr.

Role: primary

Other Identifiers

Psy001

Identifier Type: -

Identifier Source: org_study_id