Parent-Child RelationsNCT05611554
Effects of an ACT-based Psychological Treatment in Relatives of People With Intellectual Disabilities
A study testing ACT in people with Parent-Child Relations and Parental Stress, run by Universidad Europea de Madrid at 1 site in Spain.
Trial summary
Investigation of the efficacy of Acceptance and Commitment Therapy (ACT) for the psychological treatment of parental stress in relatives of people with intellectual disabilities Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parent-Child Relations, Parental Stress
- What is being tested?
- ACT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteSpain
- Study dates
- 1 Dec 2021to 15 Feb 2023
- 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
- Over 18 years of age
- High level of understanding of Spanish
- Having children diagnosed with intellectual disability
Who cannot join
- Current psychological and/or psychiatric treatment,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Parental Stress, Health and Disabilities. A Training Programme in Psychological Flexibility During COVID 19
Investigation of the efficacy of Acceptance and Commitment Therapy (ACT) for the psychological treatment of parental stress in relatives of people with intellectual disabilities
Read the detailed description
After being informed about the study, all patients giving written informed consent will be assessed to determine eligibility for study entry.
Patients who meet eligibility requirements will receive psychological intervention consisting in 3-session group ACT-based treatment.
The participants will be assessed through self-report instruments before and after treatment and at 3 months follow-up.
The clinical trial will include a control group.
- Conditions
- Parent-Child Relations, Parental Stress
- Being tested
- ACT
- Keywords
- stress, acceptance and commitment therapy, health, parent-child relations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACTBehavioural
Psychological intervention focused on (a) values clarification, (b) defusion strategies, (c) training in flexible attention to the present moment (mindfulness), and (d) committed action and psychological acceptance through metaphors and experiential exercises.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Psychological intervention will consist in an 3-session group ACT-based treatment. Receives: Behavioral: ACT |
| Waiting List | No intervention | Participants assigned to Waiting List arm waited for 5 months before receiving treatment (i.e., after completing the measures they continued in the study and received Psychological intervention five months later) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Perceived Stress Scale (PSS)
Perceived Stress Scale (PSS) is a one-dimensional scale with 14 items that are answered on a Likert-type scale ranging from 0 (Never) to 5 (Very often). The direct scores range from 0 to 56; higher scores indicate higher perceived stress and worse outcome.
Measured: Change from Baseline perceived stress at 4 months
Secondary outcomes (4)
Change in Parental Acceptance Questionnaire (6-PAQ)
Parental Acceptance Questionnaire (6-PAQ) is a 16-item questionnaire on a Likert-type scale with four answer options in a range from 1 (Strongly Disagree) to 4 (Strongly Agree) that assesses six processes related to psychological flexibility (being present, values, committed action, self as context, cognitive defusion, and acceptance) and three flexible response styles (opened, centred and committed). The scores vary from 16 to 64; the higher the score, the higher psychological inflexibility levels and worse outcome.
Measured: Change from Baseline Psychological Inflexibility at 4 months
Change in Psychological Health Questionnaire (GHQ-12)
Psychological Health Questionnaire (GHQ-12) contains 12 items on a Likert-type scale with four answer options in a range from 0 (Strongly Disagree) to 3 (Strongly Agree). Higher scores indicate lower levels of psychological well-being and worse outcome.
Measured: Change from Baseline Psychological Well-Being at 4 months
Change in White Bear Suppression Inventory (WBSI)
White Bear Suppression Inventory (WBSI) evaluates the tendency to suppress unwanted thoughts. It is a Likert scale of 15 items with five response options ranging from 1 (Completely Disagree) to 5 (Completely Agree). Scores range from 15 to 75. Higher scores indicate a stronger thought suppression tendency and worse outcomes.
Measured: Change from Baseline thoughts suppression at 4 months
Change in Behavioural self-monitoring
Behavioral self-monitoring captures behaviour change. Family members recorded a daily estimation of the frequency of two categories of behaviours: punitive-hostile behaviours from family members to children with disabilities (e.g., shouting, punishments, insults, or aggressions) and supportive-companion behaviours (e.g., helping, shared leisure and recognition or compliments). A Likert-type scale was used to estimate frequency, with values from 0 to 4 (0= never; 1= almost never; 2= sometimes; 3= often; and 4= always) Participants completed daily self-monitoring, starting one week before the intervention (forming the baseline scenario) until one week after the intervention, obtaining a total of 4 measures. Higher scores in punitive-hostile behaviours indicate higher levels of punitive-hostile behaviours and worse outcome. Higher scores in supportive-companion behaviours indicate higher levels of supportive-companion behaviours and better outcome.
Measured: Change from Baseline punitive-hostile and supportive-companion behaviours at 1 month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2022
- Study start1 Dec 2021
- Primary completion15 Jul 2022
- Study completion15 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parent-Child RelationsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization assigned participants to 2 arms: 1. Treatment 2. Waiting list
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Europea de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francisco Montesinos, PhD, Principal investigator, Universidad Europea de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05611554
- Sponsor's protocol ID
- CIPI/21/091
- Status last verified
- Nov 2022
- First submitted
- 3 Nov 2022
- Last updated
- 1 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parental Stress, Health and Disabilities. A Training Programme in Psychological Flexibility During COVID 19
- ClinicalTrials.gov ID
- NCT05611554
- Acronym / sponsor ID
- CIPI/21/091
- Conditions
- Parent-Child Relations, Parental Stress
- Keywords
- stress, acceptance and commitment therapy, health, parent-child relations
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Universidad Europea de MadridUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 15 Feb 2023 (estimated)
- First posted
- 10 Nov 2022 (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.
Investigation of the efficacy of Acceptance and Commitment Therapy (ACT) for the psychological treatment of parental stress in relatives of people with intellectual disabilities
Detailed description
After being informed about the study, all patients giving written informed consent will be assessed to determine eligibility for study entry.
Patients who meet eligibility requirements will receive psychological intervention consisting in 3-session group ACT-based treatment.
The participants will be assessed through self-report instruments before and after treatment and at 3 months follow-up.
The clinical trial will include a control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomization assigned participants to 2 arms: 1. Treatment 2. Waiting list
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: ACTPsychological intervention will consist in an 3-session group ACT-based treatment. |
| Waiting List | No intervention | –Participants assigned to Waiting List arm waited for 5 months before receiving treatment (i.e., after completing the measures they continued in the study and received Psychological intervention five months later) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Over 18 years of age
- High level of understanding of Spanish
- Having children diagnosed with intellectual disability
Key exclusion criteria (1 listed)
- Current psychological and/or psychiatric treatment,
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 |
|---|---|---|
| ACTPsychological intervention focused on (a) values clarification, (b) defusion strategies, (c) training in flexible attention to the present moment (mindfulness), and (d) committed action and psychological acceptance through metaphors and experiential exercises. | Behavioural | Treatment |
Primary outcome
Change in Perceived Stress Scale (PSS)
Time frame: Change from Baseline perceived stress at 4 months
Perceived Stress Scale (PSS) is a one-dimensional scale with 14 items that are answered on a Likert-type scale ranging from 0 (Never) to 5 (Very often). The direct scores range from 0 to 56; higher scores indicate higher perceived stress and worse outcome.
4 secondary outcomes
Change in Parental Acceptance Questionnaire (6-PAQ)
Time frame: Change from Baseline Psychological Inflexibility at 4 months
Change in Psychological Health Questionnaire (GHQ-12)
Time frame: Change from Baseline Psychological Well-Being at 4 months
Change in White Bear Suppression Inventory (WBSI)
Time frame: Change from Baseline thoughts suppression at 4 months
Change in Behavioural self-monitoring
Time frame: Change from Baseline punitive-hostile and supportive-companion behaviours at 1 month.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2022.
- Individual participant dataSharing planned: No
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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.
Francisco Montesinos, PhD principal investigator
Universidad Europea de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACT in people with Parent-Child Relations and Parental Stress, run by Universidad Europea de Madrid at 1 site 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 3 inclusion and 1 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 1 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Perceived Stress Scale (PSS) (time frame: Change from Baseline perceived stress at 4 months). 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 1 Dec 2022.