NCT03805828

Brief Summary

Health and well being of children are inextricably linked to the physical, emotional and psychological of their parents. Autism Spectrum Disorder is one of the neurological developmental disorders characterized by moderate to severe impairments in social interactions, language, and cognitive development, as well as included repetitive behaviors, restricted interests, and emotional distress. Coping with a stressful situation is classified as one of the most challenges in one's life. The overall aim of this study is to examine the effectiveness of the educational program on parenting stress and coping mechanism among parents of children with ASD in Amman, Jordan at baseline, post-test and at two months follow-up assessment. Two hundred parents of children with Autism spectrum disorder will be assigned to the intervention group (n = 100) and the control group (n = 100). Measures of parent stress and coping mechanism using the parent stress index(PSI) and Brief COPE will administer at pre-, post-treatment, and 2-months follow-up.

Trial Health

43
At Risk

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 Mar 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

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

First Submitted

Initial submission to the registry

January 8, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 16, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

January 16, 2019

Status Verified

January 1, 2019

Enrollment Period

5 months

First QC Date

January 8, 2019

Last Update Submit

January 12, 2019

Conditions

Keywords

Autism spectrum disorderparenting stresscoping mechanismcoping strategieseducation programeducational intervention

Outcome Measures

Primary Outcomes (2)

  • parenting stress

    Self reported 36 statements on three subscales: parental distress (PD), parent-child dysfunctional interaction (P-CDI), and difficulty of the child (DC). Each subscale contains 12 items. The PSI-SF rated on a 5-point Likert scale, include 1 (strongly disagree) , 2 ( disagree ), 3 ( not sure ), 4 (agree) 5 (strongly agree), total scores range from 36 to 180. On the PSI-SF, stress levels considered normal with less than 90 scores , whereas , high-stress considered at or above the 90 scores

    Mean change in scores of parenting stress from baseline to endpoint(two months follow-up) assessment

  • coping mechanism

    self-administered questionnaire twenty-eight items of the Brief COPE are grouped into fourteen subscales containing two items for each: acceptance, active coping, planning, behavioral disengagement, denial, substance use, humor, positive reframing, religious coping, self-blame, self-distraction, use of emotional support, use of instrumental support, and venting emotions . The items of subscale rated on a four-point Likert scale with a response for each item ranging from 1 ( I haven't been doing this at all ) to 4 (I have been doing this a lot)

    Mean change in scores of coping mechanism from baseline to endpoint(two months follow-up) assessment

Study Arms (2)

Expermental

EXPERIMENTAL

In the intervention group, the educational program will deliver as a one-day event in four sessions: (1)background of autism spectrum disorder(ASD) and coping mechanism,(2) targeting communication and social difficulties among ASD children using coping mechanism,(3) targeting behavior problems among ASD children using coping mechanism, and (4) stress management as coping mechanism.

Other: Educational program on parenting stress and coping mechanism

Control

ACTIVE COMPARATOR

In the control group, the educational about communicable disease among childhood deliver as a one-day event in four sessions: (1) introduction and background communicable disease of childhood,(2) communicable diseases of childhood (Chicken Pox, Diphtheria,and pertussis\[a whooping cough\]),(3) communicable diseases of childhood (Measles,Mumps,rubella\[German Measles\]and Poliomyelitis(,and (4) infection control.

Other: Educational program on parenting stress and coping mechanism

Interventions

The educational program will deliver as a one-day event in four sessions: (1)background of autism spectrum disorder(ASD) and coping mechanism,(2) targeting communication and social difficulties among ASD children using coping mechanism,(3) targeting behavior problems among ASD children using coping mechanism, and (4) stress management as coping mechanism. The contents of the educational program deliver through the use of PowerPoint slides, Whiteboard and marker, practical exercise, video clips followed by group discussion and provision a hard copy booklet containing all items which were supposed to discuss. As well as each session will approximately be taken one hour. Each group will consist of 10 participants.

ControlExpermental

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Father or mother of a child who diagnosed for the period of three years since the initial time of diagnosis
  • Father or mother who provides care and living together with the child
  • Father or mother has the ability to read and write Arabic, and (4) father or mother age above 20 years old
  • Center provides caring only for ASD child with age 12 years and younger
  • Provide the following services: speech, language, occupational, physiotherapy, educational, nutrition and medical services.

You may not qualify if:

  • Father or mother whose child had other chronic or illnesses (e.g, type 1 diabetes, down syndrome, learning disabilities, fetal alcohol syndrome)
  • Foreign father or mother of a child with ASD residents in Amman
  • Father or mother who previously participated in the intervention research (e.g, Cognitive Behavior Therapy, Mindfulness-Based Intervention)
  • Father or mother of a child who takes any pharmacologic management of ASD (e.g,Risperdal, Ritalin)
  • Father or mother with more than one child diagnosed with ASD
  • Center doesn't include a suitable classroom for implementing the intervention program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centers for the treatment of Autistic Disorder

Amman, Jordan

NOT YET RECRUITING

Ministry of Social Development

Amman, Jordan

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Central Study Contacts

Haytham Al-Oran, PhD student

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

January 8, 2019

First Posted

January 16, 2019

Study Start

March 1, 2019

Primary Completion

August 1, 2019

Study Completion

August 1, 2019

Last Updated

January 16, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will share

Primary outcomes measures will be made available

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Data will be available within 7 months
Access Criteria
Date request will be reviewed by an external independent review panel. Requesters will be required to sign the data access agreement

Locations