CClinicalTrials.gg
Active, not recruitingNCT06598605Updated Sep 24, 2024

An Intervention Program to Improve Emotion Regulation Among Parents of Children with ASD

An interventional study of Parental Reflective Functioning Workshop in ASD, sponsored by University of Haifa. Active, not recruiting at 1 site in Israel. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-24.

Sponsored by University of Haifa · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Nov 2024, 1 year 11 months ago, but the record still lists the study as active, not recruiting.
  • Registered 2 years 8 months after the study started (first participant enrolled Dec 2021, registered Sep 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • ASD

Keywords

  • ASD
  • mentalization
  • reflective function
  • emotional regulation
03

In context

Lead sponsor

University of Haifa is the lead sponsor of 101 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

A parent aged 18 or older of a child aged 2-18 years diagnosed with ASD

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    Parental Reflective Functioning intervention Group

    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.

    Behavioral: Parental Reflective Functioning Workshop

  • No intervention
    Waitless control group

    Group will undergo same measurements points with no intervention.

Interventions

  • BehavioralParental Reflective Functioning Workshop

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to 20 weeks

Secondary outcomes

  1. 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.

    Time frame: Up to 20 weeks

  2. 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).

    Time frame: Up to 20 weeks

  3. 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.

    Time frame: Up to 20 weeks

  4. 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).

    Time frame: Up to 20 weeks

  5. 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.

    Time frame: Up to 20 weeks

  6. 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.

    Time frame: Up to 20 weeks

  7. 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.

    Time frame: Up to 20 weeks

  8. 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.

    Time frame: Up to 20 weeks

  9. 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.

    Time frame: Up to 20 weeks

  10. 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.

    Time frame: Up to 20 weeks

  11. 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.

    Time frame: Up to 20 weeks

  12. 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.

    Time frame: Up to 20 weeks

  13. 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.

    Time frame: Up to 20 weeks

  14. 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).

    Time frame: Up to 20 weeks

  15. 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.

    Time frame: Up to 20 weeks

07

Study locations

1 site
  • University of Haifa
    Haifa, 3103301, Israel
08

References and documents

Individual participant data

Plan to share: Yes — All IPD excluding personal information given by participants in interview (records and transcripts), however coded information for these interview will be shared.

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 24, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06598605
Lead sponsor
University of Haifa
Responsible party
Yael Enav (Head of Emotiinal Regulation and Mentalization Lab, University of Haifa) — Principal investigator
First posted
Sep 19, 2024
Start date
Dec 14, 2021
Primary completion
Nov 1, 2024 (estimated)
Completion
Nov 2024 (estimated)
Last update
Sep 24, 2024

Study contacts

Yael Enav, Phd
principal investigator · University of Haifa

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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