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Investigation of the efficacy of Acceptance and Commitment Therapy (ACT) for the psychological treatment of parental stress in relatives of people with intellectual disabilities
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Psychological intervention will consist in an 3-session group ACT-based treatment. |
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| 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) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACT | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from Baseline perceived stress at 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francisco Montesinos, PhD | Universidad Europea de Madrid | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad Europea de Madrid | Madrid | Villaviciosa de Odón | 28670 | Spain |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 15, 2021 | Nov 3, 2022 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 15, 2021 | Nov 3, 2022 | ICF_001.pdf |
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Randomization assigned participants to 2 arms:
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The participants were aware of the existence of the two conditions
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| 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. | 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. | 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. | Change from Baseline punitive-hostile and supportive-companion behaviours at 1 month. |