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Clinical Trials/NCT05611554
NCT05611554Active, not recruitingNot Applicable

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

Universidad Europea de Madrid2 sites in 1 country21 target enrollmentStarted: December 1, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Enrollment
21
Locations
2
Primary Endpoint
Change in Perceived Stress Scale (PSS)

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Masking Description

The participants were aware of the existence of the two conditions

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
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,

Outcomes

Primary Outcomes

Change in Perceived Stress Scale (PSS)

Time Frame: 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 Outcomes

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

Investigators

Sponsor
Universidad Europea de Madrid
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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