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

NCT04267523 | Unknown DMC

• 1 other identifier: Psy001
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 2

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.

Conditions

Parents

Keywords

Parenting; Psychological flexibility; Third-wave therapies; Web-based intervention; Emotion regulation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Satisfaction with Life Scale (SWLS; Atienza, Pons, Balaguer, & García-Merita, 2000)

  Change from baseline at immediately after the intervention months, and at 3 months

• Strength and Difficulties Questionnaire, (SDQ; Gómez-Beneyto et al., 2012)

  Change from baseline at immediately after the intervention, and at 3 months

Other Outcomes (2)

• Client Satisfaction Questionnaire (Hidalgo y cols., 2013)

  Immediately after the intervention

• Parental coping and mood

  Change from baseline at immediately after the intervention

Study Arms (2)

Web-based parenting intervention

EXPERIMENTAL

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

Face-to-face parenting intervention

ACTIVE COMPARATOR

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

Interventions

Web parenting intervention 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.

Web-based parenting intervention

Group parenting intervention 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.

Face-to-face parenting intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Almeria: lead
• Universitat Jaume I: collaborator

Study Sites (2)

University of Almería

Almería, Almeria, 04120, Spain

RECRUITING

University Jaume I

Castellon, Castellón, 12071, Spain

RECRUITING

MeSH Terms

Conditions

Emotional Regulation

Condition Hierarchy (Ancestors)

Self-Control; Social Behavior; Behavior

Study Officials

• Inmaculada Gomez, Prof.

  University de Almeria

  STUDY DIRECTOR

• Azucena Garcia-Palacios, Prof.

  University Jaume I

  STUDY DIRECTOR

Central Study Contacts

Juan M. Flujas-Contreras, MD

CONTACT

+34 674 596 371; jfc397@ual.es

Inmaculada Gomez, Prf.

CONTACT

+34 950 214414; igomez@ual.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 10, 2019
• First Posted: February 13, 2020
• Study Start: December 11, 2019
• Primary Completion: December 30, 2023
• Study Completion: May 5, 2024
• Last Updated: April 30, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: The duration of the study
• Access Criteria: Not decided

Locations

ES (2)