NCT04307706

Brief Summary

This study was carried out to determine the effect of ACT-based interventions applied to parents of special needs children (CSN) on their levels of psychological inflexibility, psychological resilience, depression, anxiety, stress, and caregiver burden.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 10, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 13, 2020

Completed
Last Updated

October 19, 2020

Status Verified

October 1, 2020

Enrollment Period

3 months

First QC Date

March 10, 2020

Last Update Submit

October 15, 2020

Conditions

Outcome Measures

Primary Outcomes (4)

  • Acceptance and Action Questionnaire (AAQ-II)

    The Acceptance and Action Questionnaire consists of 7 items and evaluates information about psychological consistency. the minimum and maximum values of scale changes between 7 and 49 points. Interpretation of score for scale; the high total score obtained from the scale shows that the level of "psychological consistency" is also high.

    8 months

  • Depression, Anxiety and Stress Scale (DASS-21)

    The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress. Each of the three DASS-21 scales contains 7 items, divided into subscales with similar content. The depression scale assesses dysphoria, hopelessness, devaluation of life, self-deprecation, lack of interest / involvement, anhedonia and inertia. The anxiety scale assesses autonomic arousal, skeletal muscle effects, situational anxiety, and subjective experience of anxious affect. The stress scale is sensitive to levels of chronic non-specific arousal. It assesses difficulty relaxing, nervous arousal, and being easily upset / agitated, irritable / over-reactive and impatient. Scores for depression, anxiety and stress are calculated by summing the scores for the relevant items.

    8 months

  • Adult Psychological Resilience Scale (RSA-21)

    The Adult Psychological Resilience Scale consists of 21 items and evaluates information about psychological resilience. Minimum 21 points and maximum 105 points are obtained from the scale. The high total score obtained from the scale indicates that the level of "psychological resilience" is high.

    8 months

  • The Zarit Burden Scale

    The Zarit Burden Interview consists of 22 items and evaluates information about caregiver burden.Interpretation of Score: 0 - 21 little or no burden, 21 - 40 mild to moderate burden, 41 - 60 moderate to severe burden, 61 - 88 severe burden. The higher the score obtained, the higher the burden level

    9 months

Study Arms (2)

Intervention group

EXPERIMENTAL

''Acceptance and Commitment Therapy Based Intervention Program was applied to the intervention group

Behavioral: Acceptance and Commitment Therapy

Control group

NO INTERVENTION

Only data collection was carried out. No attempt was made by the researcher during the study.

Interventions

The Acceptance and Commitment Therapy Based Intervention Program was applied to the intervention group in six sessions. The duration of each session lasted on average 60-90 minutes. A session was held for each parent once a week.

Intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Parents with children at the Gaziantep Private Education Practice Schools I. and II. stage (the mother or father will be the person who is primarily responsible for the child's care).
  • Those living in the central districts of Gaziantep province,
  • Those who have not received any such training (ACT) or received any psychiatric treatment/support or therapy,
  • There is currently no ongoing psychological or psychiatric treatment,
  • Does not have problems such as substance/alcohol addiction,
  • Without communication disabilities (hearing and speaking),
  • Speaking Turkish,
  • Literate,
  • Parents who agreed to participate in the research

You may not qualify if:

  • Parents with cognitive impairment (mental retardation or a psychiatric diagnosis),
  • Parents who have previously received psychiatric support or therapy,
  • Parents with problems such as substance/alcohol abuse,
  • Has a communication disability (hearing-speaking),
  • Using a language other than Turkish,
  • Illiterate parents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziantep University

Gaziantep, University Boulevard, 27310, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Caregiver Burden

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

March 10, 2020

First Posted

March 13, 2020

Study Start

January 1, 2019

Primary Completion

April 1, 2019

Study Completion

December 20, 2019

Last Updated

October 19, 2020

Record last verified: 2020-10

Locations