ASDNCT06598605
An Intervention Program to Improve Emotion Regulation Among Parents of Children with ASD
A study testing Parental Reflective Functioning Workshop in people with ASD, run by University of Haifa at 1 site in Israel.
Trial summary
To examine the effectiveness of a short-term therapeutic workshop in improving reflective functioning, the belief that emotions can change, the reported use of effective emotional regulation strategies, and perceived parental self-efficacy and child behavior. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- ASD
- What is being tested?
- Parental Reflective Functioning Workshop
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- 14 Dec 2021to Nov 2024
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A parent aged 18 or older of a child aged 2-18 years diagnosed with ASD
Who cannot join
- A parent under the age of 18
- A parent of a child without an ASD diagnosis
- A parent of a child with ASD diagnosis under 2 years of age, or above 18 years of age
Trial locations and contacts
1 site in 1 country.
About this study
To examine the effectiveness of a short-term therapeutic workshop in improving reflective functioning, the belief that emotions can change, the reported use of effective emotional regulation strategies, and perceived parental self-efficacy and child behavior.
Read the detailed description
The subjects will:
Answer questionnaires and clinical interviews about the relationship with their children and their mental functioning before the workshop.
The intervention group will participate in a 4-session workshop (once a week) led by an educational psychologist specializing in autism.
Answer questionnaires and clinical interviews about emotional regulation and mental functioning among their children, and about the nature of the relationship with their children after the workshop.
- Conditions
- ASD
- Being tested
- Parental Reflective Functioning Workshop
- Keywords
- ASD, mentalization, reflective function, emotional regulation
- Medical subject headings
- Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parental Reflective Functioning WorkshopBehavioural
Four online workshop sessions via Zoom will be based on psycho-educational knowledge concerning emotional regulation and specialized in autism. The group size will be up to 15 participants, with each session lasting an hour and a half, after which participants will be asked to complete a reflective journal.
| Study group | Role | What they receive |
|---|---|---|
| Parental Reflective Functioning intervention Group | Experimental | Participants will attend four online psycho-educational workshop sessions via Zoom, where they will learn strategies for emotion regulation and mentalization to improve their relationship with their children on the autism spectrum. Receives: Behavioral: Parental Reflective Functioning Workshop |
| Waitless control group | No intervention | Group will undergo same measurements points with no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive and negative affect scale (PANAS)
The PANAS consists of 20 items, with 10 items assessing positive affect and 10 items assessing negative affect. Participants rate each item on a 5-point Likert scale ranging from 1 (very slightly or not at all) to 5 (extremely), based on how they feel over a specified time frame.
Measured: Up to 20 weeks
Secondary outcomes (15)
Depression Assessment Questionnaire(CES-D)
The CES-D consists of 20 items, each rated on a 4-point Likert scale ranging from 0 (rarely or none of the time) to 3 (most or all of the time), based on the frequency of symptoms experienced in the past week.
Measured: Up to 20 weeks
State-Trait Anxiety Inventory (STAI)
The STAI consists of 40 items, divided into two subscales: the State Anxiety Scale (S-Anxiety) with 20 items, and the Trait Anxiety Scale (T-Anxiety) with 20 items.Each item is rated on a 4-point Likert scale. For the S-Anxiety scale, the response options range from 1 (not at all) to 4 (very much so). For the T-Anxiety scale, the response options range from 1 (almost never) to 4 (almost always).
Measured: Up to 20 weeks
Beck's Depression Inventory (BDI)
The BDI-II consists of 21 multiple-choice items, each describing a specific symptom or attitude associated with depression. Each item is rated on a 4-point scale ranging from 0 to 3, reflecting the severity of the symptom over the past two weeks.
Measured: Up to 20 weeks
Interpersonal Trust Evaluation Questionnaire (ITE)
The questionnaire consists of 12 items. Each item is rated on a 6-point Likert scale ranging from 1 (Strongly Disagree) to 6 (Strongly Agree).
Measured: Up to 20 weeks
Perceived Stress Scale (PSS)
The questionnaire consists of 14 items. Respondents indicate how often they felt or thought a certain way on a scale ranging from 0 (never) to 4 (very often). Some versions may have been adapted or shortened for specific research or clinical purposes.
Measured: Up to 20 weeks
Mental Health Continuum-Short Form Questionnaire (MHC-SF)
The Mental Health Continuum-Short Form (MHC-SF) is a psychological assessment tool used to measure positive mental health. The MHC-SF is a shorter version of the Mental Health Continuum-Long Form (MHC-LF) and is designed to assess well-being across three dimensions: emotional well-being, social well-being, and psychological well-being. Each item is rated on a 6-point Likert scale, ranging from 0 ("never") to 5 ("every day"). The responses reflect the frequency of these positive experiences over the past month. Scores are calculated for each dimension, and a total score is obtained by summing the items. Higher scores indicate higher levels of well-being.
Measured: Up to 20 weeks
Subjective Happiness Scale (SHS)
The Subjective Happiness Scale (SHS) consists of four items that measure global subjective happiness. Respondents rate each item on a scale from 1 to 7, where 1 indicates "not at all" and 7 indicates "a great deal." The scale provides a total score, which is the sum of the four items, with higher scores indicating higher levels of subjective happiness.
Measured: Up to 20 weeks
Parenting Sense of Competence (PSOC)
consists of a total of 17 items. These items are divided between the two subscales: Parental Satisfaction and Parental Efficacy.Each subscale consists of several items, and respondents rate each item on a 7-point Likert scale, where higher scores indicate higher levels of satisfaction or efficacy in parenting.
Measured: Up to 20 weeks
Parental Reflective Functioning Questionnaire (PRFQ-18)
The PRFQ-18 questionnaire consists of 18 items which respondents rate each item on a 7-point Likert scale, where higher scores indicate higher levels of reflective functioning.
Measured: Up to 20 weeks
Emotion Regulation Questionnaire (ERQ)
The ERQ consists of 10 items that assess two main strategies of emotion regulation:Cognitive Reappraisal and Expressive Suppression.Respondents rate each item on a Likert scale typically ranging from 1 (strongly disagree) to 7 (strongly agree), indicating the extent to which they engage in each strategy.
Measured: Up to 20 weeks
Toronto Alexithymia Scale (TAS)
The TAS consisted of 20 items, though there are variations such as the TAS-20 which is commonly used. It assesses three main dimensions of alexithymia:Difficulty Identifying Feelings,Difficulty Describing Feelings, and Externally Oriented Thinking. Respondents typically rate each item on a Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree), indicating the extent to which each statement applies to them.
Measured: Up to 20 weeks
Parental Burnout Assessment (PBA)
23-item self-report that assesses the severity of parental burnout. It consists of four subscales: emotional exhaustion (9 items); contrast with the previous parental self (5 items); feelings of being frustrated as a parent (5 items); and emotional distancing from one's children (3 items). Items are rated on a 7-point Likert scale, from 0 = never to 6 = every day.
Measured: Up to 20 weeks
Adaptive Behavior Assessment System, Second Edition (ABAS-II)
The number of items in the ABAS-II (Second Edition) includes around 276 items across various domains and scale. The questionnaire is typically completed by a caregiver or teacher who observes the individual's behaviors over a period of time. It consists of items rated on a Likert scale or as frequency counts, depending on the specific item. Scores on the ABAS-II provide an overall picture of an individual's adaptive behavior functioning and can help in planning interventions and measuring progress.
Measured: Up to 20 weeks
Child Behavior Checklist (CBCL)
The CBCL consists of items organized into several scales and subscales that assess behavioral and emotional problems in children. It includes two main versions:CBCL/6-18 (Child Behavior Checklist for Ages 6-18), and CBCL/1.5-5 (Child Behavior Checklist for Ages 1.5-5).
The CBCL is typically completed by parents or caregivers who rate the frequency and intensity of various behaviors observed in the child over a specified period. Items are scored on a 3-point Likert scale (0 = Not True, 1 = Somewhat or Sometimes True, 2 = Very True or Often True).
Measured: Up to 20 weeks
Couples Satisfaction Index (CSI)
The Couples Satisfaction Index (CSI) typically consists of 32 items that assess various dimensions of relationship satisfaction. Respondents rate on a Likert scale, typically ranging from 1 (Very Dissatisfied) to 7 (Very Satisfied). Respondents are asked to indicate their level of agreement or satisfaction with each item based on their current perceptions of their relationship.
Measured: Up to 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start14 Dec 2021
- Primary completion1 Nov 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ASDStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Haifa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yael Enav, University of Haifa
- Investigators
- Yael Enav, Phd, Principal investigator, University of Haifa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06598605
- Sponsor's protocol ID
- 491/22
- Status last verified
- Jul 2024
- First submitted
- 9 Sep 2024
- Last updated
- 24 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD excluding personal information given by participants in interview (records and transcripts), however coded information for these interview will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Intervention Program to Improve Emotion Regulation Among Parents of Children with ASD
- ClinicalTrials.gov ID
- NCT06598605
- Acronym / sponsor ID
- 491/22
- Conditions
- ASD
- Keywords
- ASD, mentalization, reflective function, emotional regulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of HaifaUniversity, hospital or other
- Study start
- 14 Dec 2021 (actual)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 19 Sep 2024 (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.
To examine the effectiveness of a short-term therapeutic workshop in improving reflective functioning, the belief that emotions can change, the reported use of effective emotional regulation strategies, and perceived parental self-efficacy and child behavior.
Detailed description
The subjects will:
Answer questionnaires and clinical interviews about the relationship with their children and their mental functioning before the workshop.
The intervention group will participate in a 4-session workshop (once a week) led by an educational psychologist specializing in autism.
Answer questionnaires and clinical interviews about emotional regulation and mental functioning among their children, and about the nature of the relationship with their children after the workshop.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parental Reflective Functioning intervention Group | Experimental | Behavioral: Parental Reflective Functioning WorkshopParticipants will attend four online psycho-educational workshop sessions via Zoom, where they will learn strategies for emotion regulation and mentalization to improve their relationship with their children on the autism spectrum. |
| Waitless control group | No intervention | –Group will undergo same measurements points with no intervention. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- A parent aged 18 or older of a child aged 2-18 years diagnosed with ASD
Key exclusion criteria (3 listed)
- A parent under the age of 18
- A parent of a child without an ASD diagnosis
- A parent of a child with ASD diagnosis under 2 years of age, or above 18 years of age
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 |
|---|---|---|
| Parental Reflective Functioning WorkshopFour online workshop sessions via Zoom will be based on psycho-educational knowledge concerning emotional regulation and specialized in autism. The group size will be up to 15 participants, with each session lasting an hour and a half, after which participants will be asked to complete a reflective journal. | Behavioural | Parental Reflective Functioning intervention Group |
Primary outcome
Positive and negative affect scale (PANAS)
Time frame: Up to 20 weeks
The PANAS consists of 20 items, with 10 items assessing positive affect and 10 items assessing negative affect. Participants rate each item on a 5-point Likert scale ranging from 1 (very slightly or not at all) to 5 (extremely), based on how they feel over a specified time frame.
15 secondary outcomes
Depression Assessment Questionnaire(CES-D)
Time frame: Up to 20 weeks
State-Trait Anxiety Inventory (STAI)
Time frame: Up to 20 weeks
Beck's Depression Inventory (BDI)
Time frame: Up to 20 weeks
Interpersonal Trust Evaluation Questionnaire (ITE)
Time frame: Up to 20 weeks
Perceived Stress Scale (PSS)
Time frame: Up to 20 weeks
Mental Health Continuum-Short Form Questionnaire (MHC-SF)
Time frame: Up to 20 weeks
Subjective Happiness Scale (SHS)
Time frame: Up to 20 weeks
Parenting Sense of Competence (PSOC)
Time frame: Up to 20 weeks
Parental Reflective Functioning Questionnaire (PRFQ-18)
Time frame: Up to 20 weeks
Emotion Regulation Questionnaire (ERQ)
Time frame: Up to 20 weeks
Toronto Alexithymia Scale (TAS)
Time frame: Up to 20 weeks
Parental Burnout Assessment (PBA)
Time frame: Up to 20 weeks
Adaptive Behavior Assessment System, Second Edition (ABAS-II)
Time frame: Up to 20 weeks
Child Behavior Checklist (CBCL)
Time frame: Up to 20 weeks
Couples Satisfaction Index (CSI)
Time frame: Up to 20 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
- Individual participant dataSharing planned: Yes. All IPD excluding personal information given by participants in interview (records and transcripts), however coded information for these interview will be shared.
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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.
Yael Enav, Phd principal investigator
University of Haifa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parental Reflective Functioning Workshop in people with ASD, run by University of Haifa at 1 site in Israel.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 24 Sep 2024. 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 Israel. 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?
Results are not available in the source record.
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?
Positive and negative affect scale (PANAS) (time frame: Up to 20 weeks). 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 24 Sep 2024.