CClinicalTrials.gg
Status unknownNCT04267523Updated Apr 30, 2021

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

An interventional study of Web parenting intervention and Group parenting intervention in Parents, sponsored by Universidad de Almeria. Status unknown at 2 sites in Spain. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-30.

Sponsored by Universidad de Almeria · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
110
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Parents

Keywords

  • Parenting
  • Psychological flexibility
  • Third-wave therapies
  • Web-based intervention
  • Emotion regulation
03

In context

Lead sponsor

Universidad de Almeria is the lead sponsor of 71 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
110 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • BehavioralWeb 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.

  • BehavioralGroup 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.

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What researchers measure

Primary outcomes

  1. 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

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

  2. 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

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

  3. 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

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

Secondary outcomes

  1. 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

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

  2. 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

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

Other outcomes

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

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

    Time frame: Immediately after the intervention

  2. Parental coping and mood

    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

    Time frame: Change from baseline at immediately after the intervention

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Study locations

2 of 2 sites recruiting
  • University of Almería
    Almería, Almeria 04120, Spain
    • Juan M Flujas-Contreras, MD · Contact · jfc397@ual.es · 674 596 371
    • Inmaculada Gómez, Dr. · Principal investigator
    Recruiting
  • University Jaume I
    Castellón De La Plana, Castellón 12071, Spain
    • Azucena García Palacios, Dr. · Contact
    Recruiting
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References and documents

Individual participant data

Plan to share: Yes — Individual participant data will be available after deidentification.

Supporting information: Study protocol, Sap, Csr

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 30, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04267523
Lead sponsor
Universidad de Almeria
Collaborators
Universitat Jaume I
Responsible party
Juan Miguel Flujas (Principal Investigator, Universidad de Almeria) — Principal investigator
First posted
Feb 13, 2020
Start date
Dec 11, 2019
Primary completion
Dec 30, 2023 (estimated)
Completion
May 5, 2024 (estimated)
Last update
Apr 30, 2021

Study contacts

Juan M. Flujas-Contreras, MD
Contact
jfc397@ual.es
+34 674 596 371
Inmaculada Gomez, Prf.
Contact
igomez@ual.es
+34 950 214414
Inmaculada Gomez, Prof.
study director · University de Almeria
Azucena Garcia-Palacios, Prof.
study director · University Jaume I

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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