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Feasibility Study on Parents Skill Training Program for Reducing Parental Distress and Disruptive Behavior of Their Children With Autism Spectrum Disorder (ASD)

Primary Purpose

Autism Spectrum Disorder, Disruptive Behaviours

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Parent Training for Disruptive Behaviours
Sponsored by
Foundation University Islamabad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder

Eligibility Criteria

3 Years - 10 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Children aged 3 to 9 years will be recruited. The gold standard diagnostic tools i.e. the autism diagnostic observation schedule (ADOS) will be administered by a trained assessor to confirm the diagnosis of ASD.

To ensure our intervention reaches children with behavioural difficulties, children who will score > 15 on the subscale of Irritability ABC-C will be included.

Exclusion Criteria:

Potential participants with an intellectual disability and non-receptive, or who have a severe medical illness will be excluded from the study.

Although unlikely to occur, children with ASD whose parents have received any intensive parent training during the past 24 months will not be included

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Parent Training (PT)

    Parent Education (PE)

    Arm Description

    The goal of intervention plan is to teach the basic applied behaviour analysis techniques to find out the antecedent of the problem behaviour, enhance adaptive skills and reduce noncompliance. Sessions will be interactive, and action-oriented through the provision of workbooks, modelling, videos, rehearsal (with child when present), homework tasks, and feedback (Bearss et al., 2015). The parents will be trained on the protocol and delivered 60 to 90 minutes preferably individual sessions over 24 weeks.

    The Parent education group will serve as an attention-placebo condition to control for general effects of the intervention. There will be 12 core sessions and 1 home visit regarding knowledge of autism, learning about the principles of managing behavior, teaching new skills; improving social interaction and communication. Each session will last for 60 to 90 minutes over 24 weeks.

    Outcomes

    Primary Outcome Measures

    Aberrant Behavior Checklist-Community (ABC-C; Aman & Singh, 1994)
    The ABC is an informant scale rated 0 to 3 for assessing problem behaviour scales. Its subscales and respective numbers of items are as follows: 1. Irritability (15 items), 2. Social Withdrawal (16 items), 3. Stereotypic Behavior (7 items), 4. Hyperactivity/Noncompliance (16 items), and 5. Repetitive Speech (4 items).
    Parenting Stress Index, Fourth Edition Short Form (PSI-4; Abidin, 1995)
    It is a 120-item measure used to examine parental stress levels considering a parent's relationship with one of his or her children between the ages of 1 month and 12 years. There are three domains i.e, (a) child characteristics, (b) parent characteristics, and (c) situational/demographic life stress.
    Symptom Checklist-90 (SCL-90, Derogatis, Rickels, Rock, 1976)
    The SCL-90 will be used to measure the psychological distress. It is also a valid measure of screening nine symptoms including somatization, hostility, depression, anxiety, interpersonal sensitivity, social anxiety, paranoia, obsessive compulsive and agoraphobia. Sum of all the subscales indicate the psychological distress and having .98 reliability which is highly satisfactory.

    Secondary Outcome Measures

    Vineland Adaptive Behavior Scales (Vineland-II; Sparrow, Cicchetti, & Balla, 2005)
    It is used to evaluate the four broad domains including communication, daily living skills, socialization and motor skills. It also includes an optional scale to assess maladaptive behaviour.
    Home Situations Questionnaire Disorder (HSQ; Chowdhury et al, 2016)
    It is a 24-item parent rating scale from 1 (mild) to 9 (severe). It is designed to evaluate noncompliance in children with ASD.
    Clinical Global Impressions - Improvement Scale (CGI; Guy 1976)
    It is a 7-point scale designed to measure overall improvement from baseline. Scores range from 1 (very much improved) through 4 (unchanged) to 7 (very much worse). Scores of 1 or 2 at week 24 endpoint identified clinical responders.

    Full Information

    First Posted
    April 6, 2020
    Last Updated
    April 8, 2020
    Sponsor
    Foundation University Islamabad
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04339153
    Brief Title
    Feasibility Study on Parents Skill Training Program for Reducing Parental Distress and Disruptive Behavior of Their Children With Autism Spectrum Disorder (ASD)
    Official Title
    Feasibility Study on Parents Skill Training Program for Reducing Parental Distress and Disruptive Behavior of Their Children With Autism Spectrum Disorder (ASD)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 2, 2020 (Anticipated)
    Primary Completion Date
    September 2, 2021 (Anticipated)
    Study Completion Date
    September 2, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Foundation University Islamabad

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Children with Autism Spectrum Disorder (ASD) usually exhibt problematic behavioral issues such as hitting, non-compliance, tantrums, spitting, headbanging and aggression, this not only cause distress for the child but also has a significant effect on the mental health of the parents. In Pakistan, the rise in ASD children, lack of resources, non-advocacy, and limited knowledge amongst health professionals have created an alarming situation not only psychologically but also because of the economic burden. The current study is to assess the impact of a psychoeducation and parental skills training programme for reducing the parental psychological stress and disruptive behavior of their children with Autism. This is a 24 weeks parent education and behavioural management manualized programme based on the principles of applied behavior analysis. The plan will include skills training on replacing problematic behaviours with more appropriate behaviours, improving social communication in verbal and non-verbal children, and interactions with peers and others. The parents will be trained on the manualized training programme in groups or as individual sessions using modelling, role-plays and rehearsal as training methods. A total of 60 parents of ASD children, age ranges from 3 to 9 years with disruptive behaviour will be recruited. The diagnosed ASD children screened from the standardised instruments not later than six months and scored > 15 on the subscale Irritability of Aberrant Behaviour Checklist will be randomly divided into two groups, 1) parents receiving manualized training program 2) parents receiving education sessions. The baseline will be determined baseline by using parent-rated instruments for behavioural problems using the Aberrant Behaviour Checklist, Home Situation Questionnaire, Vineland Adaptive behaviour scales, Symptom Checklist 90, and Parental Distress Index. Overall there will be 12 core sessions on the Parental Education (PE) pertaining to parent education including advocacy and educational planning over 24 weeks and 11 sessions of Parent Training (PT) for managing behavioural issues of autistic children. Each session will last for 60 to 90 minutes. There will be six months follow up, and evaluation will be done by the masked assessor. All the sessions will be from a trained psychologist and behaviour analysts who have more than 1 year experience of working with children with ASD. To ensure treatment integrity, all training sessions will be assessed after every 4 weeks by using behavioural measures to evaluate the correct implementation of treatment protocol. Some of the sessions will be recorded. It is anticipated that parent training will improve the mental health of parents and reduce the disruptive behaviour of children with Autism Spectrum Disorder.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Autism Spectrum Disorder, Disruptive Behaviours

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    The study is a Randomized Controlled Trial (RCT) with single blind rating. The participants will be randomly divided into two groups. One group will receive the Parent Training (PT) and the other will get the Parent Education (PE).
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Parent Training (PT)
    Arm Type
    Experimental
    Arm Description
    The goal of intervention plan is to teach the basic applied behaviour analysis techniques to find out the antecedent of the problem behaviour, enhance adaptive skills and reduce noncompliance. Sessions will be interactive, and action-oriented through the provision of workbooks, modelling, videos, rehearsal (with child when present), homework tasks, and feedback (Bearss et al., 2015). The parents will be trained on the protocol and delivered 60 to 90 minutes preferably individual sessions over 24 weeks.
    Arm Title
    Parent Education (PE)
    Arm Type
    No Intervention
    Arm Description
    The Parent education group will serve as an attention-placebo condition to control for general effects of the intervention. There will be 12 core sessions and 1 home visit regarding knowledge of autism, learning about the principles of managing behavior, teaching new skills; improving social interaction and communication. Each session will last for 60 to 90 minutes over 24 weeks.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Parent Training for Disruptive Behaviours
    Intervention Description
    Critically, PT also involves education about autism during the initial sessions, and thus benefits of PT are inferred to come from the specific training.
    Primary Outcome Measure Information:
    Title
    Aberrant Behavior Checklist-Community (ABC-C; Aman & Singh, 1994)
    Description
    The ABC is an informant scale rated 0 to 3 for assessing problem behaviour scales. Its subscales and respective numbers of items are as follows: 1. Irritability (15 items), 2. Social Withdrawal (16 items), 3. Stereotypic Behavior (7 items), 4. Hyperactivity/Noncompliance (16 items), and 5. Repetitive Speech (4 items).
    Time Frame
    24 weeks
    Title
    Parenting Stress Index, Fourth Edition Short Form (PSI-4; Abidin, 1995)
    Description
    It is a 120-item measure used to examine parental stress levels considering a parent's relationship with one of his or her children between the ages of 1 month and 12 years. There are three domains i.e, (a) child characteristics, (b) parent characteristics, and (c) situational/demographic life stress.
    Time Frame
    24 weeks
    Title
    Symptom Checklist-90 (SCL-90, Derogatis, Rickels, Rock, 1976)
    Description
    The SCL-90 will be used to measure the psychological distress. It is also a valid measure of screening nine symptoms including somatization, hostility, depression, anxiety, interpersonal sensitivity, social anxiety, paranoia, obsessive compulsive and agoraphobia. Sum of all the subscales indicate the psychological distress and having .98 reliability which is highly satisfactory.
    Time Frame
    24 weeks
    Secondary Outcome Measure Information:
    Title
    Vineland Adaptive Behavior Scales (Vineland-II; Sparrow, Cicchetti, & Balla, 2005)
    Description
    It is used to evaluate the four broad domains including communication, daily living skills, socialization and motor skills. It also includes an optional scale to assess maladaptive behaviour.
    Time Frame
    24 weeks
    Title
    Home Situations Questionnaire Disorder (HSQ; Chowdhury et al, 2016)
    Description
    It is a 24-item parent rating scale from 1 (mild) to 9 (severe). It is designed to evaluate noncompliance in children with ASD.
    Time Frame
    24 weeks
    Title
    Clinical Global Impressions - Improvement Scale (CGI; Guy 1976)
    Description
    It is a 7-point scale designed to measure overall improvement from baseline. Scores range from 1 (very much improved) through 4 (unchanged) to 7 (very much worse). Scores of 1 or 2 at week 24 endpoint identified clinical responders.
    Time Frame
    24 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    3 Years
    Maximum Age & Unit of Time
    10 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Children aged 3 to 9 years will be recruited. The gold standard diagnostic tools i.e. the autism diagnostic observation schedule (ADOS) will be administered by a trained assessor to confirm the diagnosis of ASD. To ensure our intervention reaches children with behavioural difficulties, children who will score > 15 on the subscale of Irritability ABC-C will be included. Exclusion Criteria: Potential participants with an intellectual disability and non-receptive, or who have a severe medical illness will be excluded from the study. Although unlikely to occur, children with ASD whose parents have received any intensive parent training during the past 24 months will not be included
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Nadia Shafique, PhD
    Phone
    03335513401
    Email
    nadiashafique17@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Nasim Chaudhry, Dr. Prof.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Nadia Shafique, Dr
    Organizational Affiliation
    FUI
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Nasim Chaudhary, Dr. Prof.
    Organizational Affiliation
    FUI
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Nusrat Hussain, Dr. Prof.
    Organizational Affiliation
    University of Manchester
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Jumana Ahmad
    Organizational Affiliation
    Greenwich University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Feasibility Study on Parents Skill Training Program for Reducing Parental Distress and Disruptive Behavior of Their Children With Autism Spectrum Disorder (ASD)

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