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

Sponsor
Universidad Europea de Madrid (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05611554
Collaborator
(none)
21
1
2
14.5
1.4

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: ACT
N/A

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

Study Type:
Interventional
Actual Enrollment :
21 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomization assigned participants to 2 arms: Treatment Waiting listRandomization assigned participants to 2 arms:Treatment Waiting list
Masking:
None (Open Label)
Masking Description:
The participants were aware of the existence of the two conditions
Primary Purpose:
Treatment
Official Title:
Parental Stress, Health and Disabilities. A Training Programme in Psychological Flexibility During COVID 19
Actual Study Start Date :
Dec 1, 2021
Actual Primary Completion Date :
Jul 15, 2022
Anticipated Study Completion Date :
Feb 15, 2023

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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,

Contacts and Locations

Locations

Site City State Country Postal Code
1 Universidad Europea de Madrid Madrid Villaviciosa De Odón Spain 28670

Sponsors and Collaborators

  • Universidad Europea de Madrid

Investigators

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

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Universidad Europea de Madrid
ClinicalTrials.gov Identifier:
NCT05611554
Other Study ID Numbers:
  • CIPI/21/091
First Posted:
Nov 10, 2022
Last Update Posted:
Dec 1, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Universidad Europea de Madrid

Study Results

No Results Posted as of Dec 1, 2022