Effects of an ACT-based Psychological Treatment in Relatives of People With Intellectual Disabilities

Parent-Child Relations Clinical Trial

Official title:

Parental Stress, Health and Disabilities. A Training Programme in Psychological Flexibility During COVID 19

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05611554
• Other study ID #: CIPI/21/091
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: February 15, 2023

Study information

• Verified date: November 2022
• Source: Universidad Europea de Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 21
• Est. completion date: February 15, 2023
• Est. primary completion date: July 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Over 18 years of age
• High level of understanding of Spanish
• Having children diagnosed with intellectual disability

Exclusion Criteria:

• Current psychological and/or psychiatric treatment,

Related Conditions & MeSH terms

• Parent-Child Relations
• Parental Stress

Intervention

Behavioral:
• ACT
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.

Locations

Country	Name	City	State
Spain	Universidad Europea de Madrid	Madrid	Villaviciosa De Odón

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Europea de Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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.	Change from Baseline Psychological Inflexibility at 4 months
Secondary	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
Secondary	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
Secondary	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.