Clinical trial NCT06598605: An Intervention Program to Improve Emotion Regulation Among Parents of Children with ASD
Official title: An Intervention Program to Improve Emotion Regulation Among Parents of Children with ASD
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: ASD
Keywords: ASD
mentalization
reflective function
emotional regulation
Lead sponsor: University of Haifa
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Positive and negative affect scale (PANAS)
timeFrame: Up to 20 weeks
Secondary outcomes:
measure: Depression Assessment Questionnaire(CES-D)
timeFrame: Up to 20 weeks
measure: State-Trait Anxiety Inventory (STAI)
timeFrame: Up to 20 weeks
measure: Beck's Depression Inventory (BDI)
timeFrame: Up to 20 weeks
measure: Interpersonal Trust Evaluation Questionnaire (ITE)
timeFrame: Up to 20 weeks
measure: Perceived Stress Scale (PSS)
timeFrame: Up to 20 weeks
measure: Mental Health Continuum-Short Form Questionnaire (MHC-SF)
timeFrame: Up to 20 weeks
measure: Subjective Happiness Scale (SHS)
timeFrame: Up to 20 weeks
measure: Parenting Sense of Competence (PSOC)
timeFrame: Up to 20 weeks
measure: Parental Reflective Functioning Questionnaire (PRFQ-18)
timeFrame: Up to 20 weeks
measure: Emotion Regulation Questionnaire (ERQ)
timeFrame: Up to 20 weeks
measure: Toronto Alexithymia Scale (TAS)
timeFrame: Up to 20 weeks
measure: Parental Burnout Assessment (PBA)
timeFrame: Up to 20 weeks
measure: Adaptive Behavior Assessment System, Second Edition (ABAS-II)
timeFrame: Up to 20 weeks
measure: Child Behavior Checklist (CBCL)
timeFrame: Up to 20 weeks
measure: Couples Satisfaction Index (CSI)
timeFrame: Up to 20 weeks
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: University of Haifa
Study officials:
affiliation: University of Haifa
name: Yael Enav, Phd
role: PRINCIPAL_INVESTIGATOR
References: