Acceptance and Commitment TherapyACTNCT04307706
Using Acceptance and Commitment Therapy for Parents of Disabled Child
A study testing Acceptance and Commitment Therapy in people with Acceptance and Commitment Therapy and Anxiety Depression, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acceptance and Commitment Therapy, Anxiety Depression, Caregiver Burden
- What is being tested?
- Acceptance and Commitment Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 20 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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),
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- Speaking Turkish,
- Literate,
- Parents who agreed to participate in the research
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziantep University
Gaziantep, University Boulevard, 27310
About this study
Official title: Effect of Interventions Based on Acceptance and Commitment Therapy Administered to Parents of Special Needs Children on Their Levels of Psychological Resilience, Depression, Anxiety, Stress and Caregiver Burden: A Randomised Controlled Trial
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.
Read the detailed description
This research is a pretest, posttest, follow-up, randomized controlled experimental study. The research was carried out in Şehitkamil and Şahinbey districts, which are two central districts of Gaziantep Province. 60 parents with disabled children were included in the study (intervention: 30 parents, control: 30 parents). The research data was collected as pretest, posttest and follow-up test from the intervention group between April and December 2019, and the control group between April and September 2019 in three stages. Parental Identification Form, Acceptance and Action Questionnaire (AAQ-II), Depression, Anxiety and Stress Scale (DASS-21), Adult Psychological Resilience Scale (RSA-21) were used as data collection form. After the pre-test data was collected, 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. The control group participated in the training carried out by the guidance service.
The intervention programme based on ACT was prepared with the aim of reducing levels of psychological inflexibility, caregiver burden, depression, anxiety and stress, and of increasing levels of psychological resilience in parents of CSN.
In the preparation of the interventions and planning of the sessions based on ACT, the researcher utilised studies in the literature and the basic ACT training she had received. After preparation of the ACT intervention protocol, it was given its final shape by obtaining the views of specialists working in this field. The sessions were prepared based on six components of psychological flexibility found at the basis of ACT.
Keywords: Acceptance and commitment therapy (ACT), special needs child, psychological inflexibility, resilience, depression-anxiety-stress levels, caregiver burden, public health nurse.
- Conditions
- Acceptance and Commitment Therapy, Anxiety Depression, Caregiver Burden, Public Health Nurse, Stress, Special Needs Children
- Being tested
- Acceptance and Commitment Therapy
- Medical subject headings
- Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | ''Acceptance and Commitment Therapy Based Intervention Program was applied to the intervention group Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2020
- Study start1 Jan 2019
- Primary completion1 Apr 2019
- Study completion20 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acceptance and Commitment TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ecem CICEK GUMUS, University of Gaziantep
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04307706
- Sponsor's protocol ID
- TDK-2019-4588
- Acronym
- ACT
- Status last verified
- Oct 2020
- First submitted
- 10 Mar 2020
- Last updated
- 19 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Interventions Based on Acceptance and Commitment Therapy Administered to Parents of Special Needs Children on Their Levels of Psychological Resilience, Depression, Anxiety, Stress and Caregiver Burden: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04307706
- Acronym / sponsor ID
- ACT / TDK-2019-4588
- Conditions
- Acceptance and Commitment Therapy, Anxiety Depression, Caregiver Burden, Public Health Nurse, Stress, Special Needs Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 13 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This research is a pretest, posttest, follow-up, randomized controlled experimental study. The research was carried out in Şehitkamil and Şahinbey districts, which are two central districts of Gaziantep Province. 60 parents with disabled children were included in the study (intervention: 30 parents, control: 30 parents). The research data was collected as pretest, posttest and follow-up test from the intervention group between April and December 2019, and the control group between April and September 2019 in three stages. Parental Identification Form, Acceptance and Action Questionnaire (AAQ-II), Depression, Anxiety and Stress Scale (DASS-21), Adult Psychological Resilience Scale (RSA-21) were used as data collection form. After the pre-test data was collected, 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. The control group participated in the training carried out by the guidance service.
The intervention programme based on ACT was prepared with the aim of reducing levels of psychological inflexibility, caregiver burden, depression, anxiety and stress, and of increasing levels of psychological resilience in parents of CSN.
In the preparation of the interventions and planning of the sessions based on ACT, the researcher utilised studies in the literature and the basic ACT training she had received. After preparation of the ACT intervention protocol, it was given its final shape by obtaining the views of specialists working in this field. The sessions were prepared based on six components of psychological flexibility found at the basis of ACT.
Keywords: Acceptance and commitment therapy (ACT), special needs child, psychological inflexibility, resilience, depression-anxiety-stress levels, caregiver burden, public health nurse.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Acceptance and Commitment Therapy''Acceptance and Commitment Therapy Based Intervention Program was applied to the intervention group |
| Control group | No intervention | –Only data collection was carried out. No attempt was made by the researcher during the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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,
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acceptance and Commitment TherapyThe 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. | Behavioural | Intervention group |
Primary outcome
Acceptance and Action Questionnaire (AAQ-II)
Time frame: 8 months
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.
Depression, Anxiety and Stress Scale (DASS-21)
Time frame: 8 months
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.
Adult Psychological Resilience Scale (RSA-21)
Time frame: 8 months
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.
The Zarit Burden Scale
Time frame: 9 months
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and Commitment Therapy in people with Acceptance and Commitment Therapy and Anxiety Depression, run by Akdeniz University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptance and Action Questionnaire (AAQ-II) (time frame: 8 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.