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

NCT ID: NCT06598605

Last Updated: 2024-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-14

Study Completion Date

2024-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

ASD

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Parental Reflective Functioning Workshop

Intervention Type 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.

Waitless control group

Group will undergo same measurements points with no intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Parental 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Haifa

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Yael Enav

Head of Emotiinal Regulation and Mentalization Lab

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yael Enav, Phd

Role: PRINCIPAL_INVESTIGATOR

University of Haifa

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Haifa

Haifa, , Israel

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Israel

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

491/22

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.