NCT06598605

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 14, 2021

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

September 24, 2024

Status Verified

July 1, 2024

Enrollment Period

2.9 years

First QC Date

September 9, 2024

Last Update Submit

September 22, 2024

Conditions

ASD

Keywords

ASDmentalizationreflective functionemotional regulation

Outcome Measures

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.

    Up to 20 weeks

Secondary Outcomes (15)

  • Depression Assessment Questionnaire(CES-D)

    Up to 20 weeks

  • State-Trait Anxiety Inventory (STAI)

    Up to 20 weeks

  • Beck's Depression Inventory (BDI)

    Up to 20 weeks

  • Interpersonal Trust Evaluation Questionnaire (ITE)

    Up to 20 weeks

  • Perceived Stress Scale (PSS)

    Up to 20 weeks

  • +10 more secondary outcomes

Study Arms (2)

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.

Behavioral: Parental Reflective Functioning Workshop

Waitless control group

NO INTERVENTION

Group will undergo same measurements points with no intervention.

Interventions

Parental Reflective Functioning WorkshopBEHAVIORAL

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.

Parental Reflective Functioning intervention Group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Haifa

Haifa, 3103301, Israel

Location

MeSH Terms

Conditions

Emotional Regulation

Condition Hierarchy (Ancestors)

Self-ControlSocial BehaviorBehavior

Study Officials

  • Yael Enav, Phd

    University of Haifa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Emotiinal Regulation and Mentalization Lab

Study Record Dates

First Submitted

September 9, 2024

First Posted

September 19, 2024

Study Start

December 14, 2021

Primary Completion

November 1, 2024

Study Completion

November 1, 2024

Last Updated

September 24, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Data will be available beginning 2 years after publication of the primary study results and will be available for 5 years.
Access Criteria
1. Eligibility\*: Access restricted to reseachers affiliated with accredited academic institutions or healthcare organizations with relevant credentials. 2. Application\*: Sumbit application form, research roposal, and CV to the principal investigator or designated contact. 3. Review and Approval\*: Applications reviewed by the data access committee. Decision within 4-6 weeks. 4. Conditions of Use\*: Data to be used solely for the approved project. Maintain confidentiality and data security. No third-party sharing withour approval. 5. Publicatins and Reorting\*: Sumbit summary or findings within 12 months.Acknowledge original study in publications and provide copies to the principal investigator.
More information

Locations

IL(1)