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

Not Applicable

Active, not recruiting

• Conditions: Parent-Child Relations; Parental Stress
• Interventions: Behavioral: ACT

• Registration Number: NCT05611554
• Lead Sponsor: Universidad Europea de Madrid

Brief 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

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 Timeline

• Study Start: 2021-12-01
• Primary Completion: 2022-07-15
• Status Verified: 2022-11
• Study First Submitted: 2022-11-03
• Study First Submitted QC: 2022-11-03
• Study First Posted: 2022-11-10
• Last Update Submitted: 2022-11-28
• Last Update Posted: 2022-12-01
• Study Completion: 2023-02-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 21

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	ACT	Psychological intervention will consist in an 3-session group ACT-based treatment.

Primary Outcome Measures

Name	Time	Method
Change in Perceived Stress Scale (PSS)	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.

Secondary Outcome Measures

Name	Time	Method
Change in White Bear Suppression Inventory (WBSI)	Change from Baseline thoughts suppression at 4 months	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 in Psychological Health Questionnaire (GHQ-12)	Change from Baseline Psychological Well-Being at 4 months	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 in Parental Acceptance Questionnaire (6-PAQ)	Change from Baseline Psychological Inflexibility at 4 months	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 in Behavioural self-monitoring	Change from Baseline punitive-hostile and supportive-companion behaviours at 1 month.	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.

Trial Locations

Locations (1)

Universidad Europea de Madrid; 🇪🇸 Madrid, Villaviciosa De Odón, Spain