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

Sponsor
Universidad de Almeria (Other)
Overall Status
Recruiting
CT.gov ID
NCT04267523
Collaborator
Universitat Jaume I (Other)
110
2
2
52.8
55
1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Web parenting intervention
  • Behavioral: Group parenting intervention
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
110 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effectiveness of a Web-based Intervention on Parental Psychological Flexibility and Emotion Regulation
Actual Study Start Date :
Dec 11, 2019
Anticipated Primary Completion Date :
Dec 30, 2023
Anticipated Study Completion Date :
May 5, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Parental Acceptance Questionnaire (Flujas-Contreras, García-Palacios, & Gómez, 2018) [Change from baseline at immediately after the intervention, and at 3 months]

    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

  2. Difficulties Emotion Regulation Scale (DERS: Hervás & Jódar, 2008) [Change from baseline at immediately after the intervention, and at 3 months]

    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

  3. Parental Stress Scale (PSS; Alonso-Arbiol y Balluerka, 2007) [Change from baseline at immediately after the intervention, and at 3 months]

    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

Secondary Outcome Measures

  1. Satisfaction with Life Scale (SWLS; Atienza, Pons, Balaguer, & García-Merita, 2000) [Change from baseline at immediately after the intervention months, and at 3 months]

    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

  2. Strength and Difficulties Questionnaire, (SDQ; Gómez-Beneyto et al., 2012) [Change from baseline at immediately after the intervention, and at 3 months]

    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

Other Outcome Measures

  1. Client Satisfaction Questionnaire (Hidalgo y cols., 2013) [Immediately after the intervention]

    It consists of 8 items on a 4-point Likert scale that assesses satisfaction in a one-dimensional way

  2. Parental coping and mood [Change from baseline at immediately after the intervention]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  1. 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).

  2. Obtain a high score in parental inflexibility / emotional distress through the Parental Acceptance Questionnaire in any of its subscales.

  3. Parents/guardians have a device that provides access to the web-based intervention.

  4. They agree to participate in the study by signing the informed consent

Exclusion Criteria:
  1. 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.

  2. The parent/guardian has serious psychological or substance use problems or disorders that may hinder their participation in the study.

  3. The parent/guardian presents Spanish comprehension barriers.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Almería Almería Almeria Spain 04120
2 University Jaume I Castellón De La Plana Castellón Spain 12071

Sponsors and Collaborators

  • Universidad de Almeria
  • Universitat Jaume I

Investigators

  • Study Director: Inmaculada Gomez, Prof., University de Almeria
  • Study Director: Azucena Garcia-Palacios, Prof., University Jaume I

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Juan Miguel Flujas, Principal Investigator, Universidad de Almeria
ClinicalTrials.gov Identifier:
NCT04267523
Other Study ID Numbers:
  • Psy001
First Posted:
Feb 13, 2020
Last Update Posted:
Apr 30, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Juan Miguel Flujas, Principal Investigator, Universidad de Almeria

Study Results

No Results Posted as of Apr 30, 2021