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

NCT05611554 | Unknown

• 1 other identifier: CIPI/21/091
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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

Conditions

Parent-Child Relations; Parental Stress

Keywords

stress; acceptance and commitment therapy; health; parent-child relations

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in Parental Acceptance Questionnaire (6-PAQ)

  Change from Baseline Psychological Inflexibility at 4 months

• Change in Psychological Health Questionnaire (GHQ-12)

  Change from Baseline Psychological Well-Being at 4 months

• Change in White Bear Suppression Inventory (WBSI)

  Change from Baseline thoughts suppression at 4 months

• Change in Behavioural self-monitoring

  Change from Baseline punitive-hostile and supportive-companion behaviours at 1 month.

Study Arms (2)

Treatment

EXPERIMENTAL

Psychological intervention will consist in an 3-session group ACT-based treatment.

Behavioral: ACT

Waiting List

NO INTERVENTION

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)

Interventions

ACT BEHAVIORAL

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.

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Current psychological and/or psychiatric treatment,

Sponsors & Collaborators

• Universidad Europea de Madrid: lead

Study Sites (1)

Universidad Europea de Madrid

Madrid, Villaviciosa de Odón, 28670, Spain

Location

Study Officials

• Francisco Montesinos, PhD

  Universidad Europea de Madrid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The participants were aware of the existence of the two conditions
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomization assigned participants to 2 arms: 1. Treatment 2. Waiting list

Study Record Dates

• First Submitted: November 3, 2022
• First Posted: November 10, 2022
• Study Start: December 1, 2021
• Primary Completion: July 15, 2022
• Study Completion: February 15, 2023
• Last Updated: December 1, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)