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Active, Not Recruiting

NCT Number: NCT06598605

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Haifa

Haifa, 3103301, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Treatment and study plan

Parental Reflective Functioning Workshop

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Depression Assessment Questionnaire(CES-D)

    Time frame: Up to 20 weeks

    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.

  2. State-Trait Anxiety Inventory (STAI)

    Time frame: Up to 20 weeks

    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).

  3. Beck's Depression Inventory (BDI)

    Time frame: Up to 20 weeks

    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.

  4. Interpersonal Trust Evaluation Questionnaire (ITE)

    Time frame: Up to 20 weeks

    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).

  5. Perceived Stress Scale (PSS)

    Time frame: Up to 20 weeks

    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.

  6. Mental Health Continuum-Short Form Questionnaire (MHC-SF)

    Time frame: Up to 20 weeks

    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.

  7. Subjective Happiness Scale (SHS)

    Time frame: Up to 20 weeks

    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.

  8. Parenting Sense of Competence (PSOC)

    Time frame: Up to 20 weeks

    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.

  9. Parental Reflective Functioning Questionnaire (PRFQ-18)

    Time frame: Up to 20 weeks

    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.

  10. Emotion Regulation Questionnaire (ERQ)

    Time frame: Up to 20 weeks

    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.

  11. Toronto Alexithymia Scale (TAS)

    Time frame: Up to 20 weeks

    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.

  12. Parental Burnout Assessment (PBA)

    Time frame: Up to 20 weeks

    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.

  13. Adaptive Behavior Assessment System, Second Edition (ABAS-II)

    Time frame: Up to 20 weeks

    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.

  14. Child Behavior Checklist (CBCL)

    Time frame: Up to 20 weeks

    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).

  15. Couples Satisfaction Index (CSI)

    Time frame: Up to 20 weeks

    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.

Sponsors and collaborators

Lead sponsor

University of Haifa

Other

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Sep 19, 2024
Registry last updated
Sep 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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