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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Parents

Intervention / Treatment
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* Behavioral: Web parenting intervention
* Behavioral: Group parenting intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Web-based parenting intervention<br>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<br>* 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.<br>|
| Active Comparator: Face-to-face parenting intervention<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parenting, Psychological flexibility, Third-wave therapies, Web-based intervention, Emotion regulation