Clinical trial NCT04267523: Effectiveness of a Web-based Intervention on Parental Psychological Flexibility and Emotion Regulation
Official title: Effectiveness of a Web-based Intervention on Parental Psychological Flexibility and Emotion Regulation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parents
Keywords: Parenting
Psychological flexibility
Third-wave therapies
Web-based intervention
Emotion regulation
Lead sponsor: Universidad de Almeria
Sponsor class: OTHER
Collaborators: name: Universitat Jaume I
First posted: 2020-02-13
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Parental Acceptance Questionnaire (Flujas-Contreras, García-Palacios, & Gómez, 2018)
timeFrame: Change from baseline at immediately after the intervention, and at 3 months
measure: Difficulties Emotion Regulation Scale (DERS: Hervás & Jódar, 2008)
timeFrame: Change from baseline at immediately after the intervention, and at 3 months
measure: Parental Stress Scale (PSS; Alonso-Arbiol y Balluerka, 2007)
timeFrame: Change from baseline at immediately after the intervention, and at 3 months
Secondary outcomes:
measure: Satisfaction with Life Scale (SWLS; Atienza, Pons, Balaguer, & García-Merita, 2000)
timeFrame: Change from baseline at immediately after the intervention months, and at 3 months
measure: Strength and Difficulties Questionnaire, (SDQ; Gómez-Beneyto et al., 2012)
timeFrame: Change from baseline at immediately after the intervention, and at 3 months
Other outcomes:
measure: Client Satisfaction Questionnaire (Hidalgo y cols., 2013)
timeFrame: Immediately after the intervention
measure: Parental coping and mood
timeFrame: Change from baseline at immediately after the intervention
Locations:
city: Almería
country: Spain
facility: University of Almería
state: Almeria
city: Castellón De La Plana
country: Spain
facility: University Jaume I
state: Castellón
Study officials:
affiliation: University de Almeria
name: Inmaculada Gomez, Prof.
role: STUDY_DIRECTOR
affiliation: University Jaume I
name: Azucena Garcia-Palacios, Prof.
role: STUDY_DIRECTOR
References: