ParentsNCT04267523
Effectiveness of a Web-based Intervention on Parental Psychological Flexibility and Emotion Regulation
A study testing Web parenting intervention and Group parenting intervention in people with Parents, run by Universidad de Almeria at 2 sites in Spain.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parents
- What is being tested?
- Web parenting intervention and Group parenting intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 2 sitesSpain
- Study dates
- 11 Dec 2019to 5 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
- Obtain a high score in parental inflexibility / emotional distress through the Parental Acceptance Questionnaire in any of its subscales.
- Parents/guardians have a device that provides access to the web-based intervention.
- They agree to participate in the study by signing the informed consent
Who cannot join
- 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.
- The parent/guardian has serious psychological or substance use problems or disorders that may hinder their participation in the study.
- The parent/guardian presents Spanish comprehension barriers.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites, 2 recruiting
- Recruiting
University of Almería
Almería, Almeria, 04120
Juan M Flujas-Contreras, MD, 674 596 371, jfc397@ual.es
Inmaculada Gómez, Dr.
- Recruiting
University Jaume I
Castellon, Castellón, 12071
Azucena García Palacios, Dr.
About this study
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.
- Conditions
- Parents
- Being tested
- Web parenting intervention, Group parenting intervention
- Keywords
- Parenting, Psychological flexibility, Third-wave therapies, Web-based intervention, Emotion regulation
- Medical subject headings
- Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web parenting interventionBehavioural
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.
Group parenting interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Group parenting intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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)
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
Measured: 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
Measured: Change from baseline at immediately after the intervention, and at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2020
- Study start11 Dec 2019
- Primary completion30 Dec 2023 (estimated)
- Study completion5 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParentsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Almeria
- Sponsor type
- University, hospital or other
- Collaborators
- Universitat Jaume I
- Responsible party
- Principal investigator, Juan Miguel Flujas, Universidad de Almeria
- Investigators
- Inmaculada Gomez, Prof., Study director, University de AlmeriaAzucena Garcia-Palacios, Prof., Study director, University Jaume I
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04267523
- Sponsor's protocol ID
- Psy001
- Status last verified
- Apr 2021
- First submitted
- 10 Dec 2019
- Last updated
- 30 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data will be available after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Web-based Intervention on Parental Psychological Flexibility and Emotion Regulation
- ClinicalTrials.gov ID
- NCT04267523
- Acronym / sponsor ID
- Psy001
- Conditions
- Parents
- Keywords
- Parenting, Psychological flexibility, Third-wave therapies, Web-based intervention, Emotion regulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Universidad de AlmeriaUniversity, hospital or other
- Collaborators
- Universitat Jaume I
- Study start
- 11 Dec 2019 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 5 May 2024 (estimated)
- First posted
- 13 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Web-based parenting intervention | Experimental | Behavioral: Web parenting interventionFamilies randomized to this intervention group will receive a self-administered web-based parenting intervention. Parents have access to a weekly 6-modules parenting intervention. |
| Face-to-face parenting intervention | Active comparator | Behavioral: Group parenting interventionFamilies randomized to this intervention group will receive a face-to-face group parenting intervention. Groups will meet weekly for 120 minutes for 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
- Obtain a high score in parental inflexibility / emotional distress through the Parental Acceptance Questionnaire in any of its subscales.
- Parents/guardians have a device that provides access to the web-based intervention.
- They agree to participate in the study by signing the informed consent
Key exclusion criteria (3 listed)
- 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.
- The parent/guardian has serious psychological or substance use problems or disorders that may hinder their participation in the study.
- The parent/guardian presents Spanish comprehension barriers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Web parenting interventionParents 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. | Behavioural | Web-based parenting intervention |
| Group parenting interventionParents 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. | Behavioural | Face-to-face parenting intervention |
Primary outcome
Parental Acceptance Questionnaire (Flujas-Contreras, García-Palacios, & Gómez, 2018)
Time frame: 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
Difficulties Emotion Regulation Scale (DERS: Hervás & Jódar, 2008)
Time frame: 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
Parental Stress Scale (PSS; Alonso-Arbiol y Balluerka, 2007)
Time frame: 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
2 secondary outcomes
Satisfaction with Life Scale (SWLS; Atienza, Pons, Balaguer, & García-Merita, 2000)
Time frame: Change from baseline at immediately after the intervention months, and at 3 months
Strength and Difficulties Questionnaire, (SDQ; Gómez-Beneyto et al., 2012)
Time frame: Change from baseline at immediately after the intervention, and at 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2021.
- Individual participant dataSharing planned: Yes. Individual participant data will be available after deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Inmaculada Gomez, Prof. study director
University de Almeria
Azucena Garcia-Palacios, Prof. study director
University Jaume I
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web parenting intervention and Group parenting intervention in people with Parents, run by Universidad de Almeria at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juan M. Flujas-Contreras, MD (+34 674 596 371, jfc397@ual.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parental Acceptance Questionnaire (Flujas-Contreras, García-Palacios, & Gómez, 2018) (time frame: Change from baseline at immediately after the intervention, and at 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2021.