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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Parent-Child Relations; Parental Stress
• Intervention / Treatment: Behavioral: ACT

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 Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Villaviciosa De Odón
    • Madrid, Villaviciosa De Odón, Spain, 28670
      • Universidad Europea de Madrid

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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,

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; Psychological intervention will consist in an 3-session group ACT-based treatment.	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.
No Intervention: Waiting List; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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.

Collaborators and Investigators

• Sponsor: Universidad Europea de Madrid
• Investigators: Principal Investigator: Francisco Montesinos, PhD, Universidad Europea de Madrid

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): July 15, 2022
• Study Completion (Anticipated): February 15, 2023

Study Registration Dates

• First Submitted: November 3, 2022
• First Submitted That Met QC Criteria: November 3, 2022
• First Posted (Actual): November 10, 2022

Study Record Updates

• Last Update Posted (Actual): December 1, 2022
• Last Update Submitted That Met QC Criteria: November 28, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: health; acceptance and commitment therapy; stress; parent-child relations
• Other Study ID Numbers: CIPI/21/091

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No