NCT05568303

Brief Summary

Cognitive behavioral therapy sessions can effectively reduce distress in mothers of children with autism. here we emphasize on the role of problem solving appraisal in CBT sessions to improve problem solving skills ability and minimize psychological distress . pre- intervention assessment (T1) for all participants , then designed 8 sessions for study group will apply . post intervention assessment (T2) will conduct immediately after CBT sessions

Trial Health

90
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

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

June 1, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 1, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 5, 2022

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

5 months

First QC Date

October 1, 2022

Last Update Submit

February 4, 2023

Conditions

Keywords

Autism disorders, maternal stress

Outcome Measures

Primary Outcomes (2)

  • Change in mean scores of psychological distress scores among study group post intervention

    Change in mean scores of psychological distress

    two months

  • Change in mean scores of problem solving skills inventor among study group post intervention

    Change in mean scores of problem solving skills inventory

    2 months

Study Arms (2)

study ( interventional ) group

EXPERIMENTAL

this group received 8 sessions of CBT

Behavioral: CBT techniques

Control group

NO INTERVENTION

they will receive on intervention sessions or any education researchers makes meeting every month to answer any questions and to maintain continuity of relation with participants

Interventions

CBT techniquesBEHAVIORAL

through CBT sessions , the participants apply problem solving process in managing their stressors . examining the role of cognitions, emotions, and behaviors to form cause and effect relationship of participants psychological distress

study ( interventional ) group

Eligibility Criteria

Age20 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsonly mothers of autistics children's involve
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Mothers caregivers who have:
  • A child with autism spectrum disorders diagnosed science at least 6 months , and her/ his diagnosis done by a psychiatrist
  • Just one child with autistic disorder
  • Their ages between 20-50 years old
  • Did not expose to previous interventional / rehabilitation programs for his/her child.

You may not qualify if:

  • have a diagnosis of any of psychiatric disorders
  • Being absent more than three sessions in study group
  • Intelligence level below 70
  • Have severe deterioration
  • Receive psychiatric medication
  • Have multiple disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Governmental Clinic

Behera Governate, Beera, 22516, Egypt

Location

Enas Mahrous Abdelaziz

JOUF, 00966, Saudi Arabia

Location

Study Officials

  • Enas M Abdelaziz, PhD

    Jouf University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

October 1, 2022

First Posted

October 5, 2022

Study Start

June 1, 2022

Primary Completion

October 31, 2022

Study Completion

January 1, 2023

Last Updated

February 8, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

based on request from principle investigator

Locations