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

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.

Study Overview

• Status: Unknown
• Conditions: Autism Spectrum Disorder; Disruptive Behaviours
• Intervention / Treatment: Behavioral: Parent Training for Disruptive Behaviours

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nadia Shafique, PhD; Phone Number: 03335513401; Email: nadiashafique17@gmail.com
• Study Contact Backup: Name: Nasim Chaudhry, Dr. Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 10 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Parent Training (PT); 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.	Behavioral: Parent Training for Disruptive Behaviours; Critically, PT also involves education about autism during the initial sessions, and thus benefits of PT are inferred to come from the specific training.
NO_INTERVENTION: Parent Education (PE); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	24 weeks
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.	24 weeks
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.	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 weeks
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.	24 weeks
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.	24 weeks

Collaborators and Investigators

• Sponsor: Foundation University Islamabad
• Investigators: Principal Investigator: Nadia Shafique, Dr, FUI; Study Chair: Nasim Chaudhary, Dr. Prof., FUI; Principal Investigator: Nusrat Hussain, Dr. Prof., University of Manchester; Principal Investigator: Jumana Ahmad, Greenwich University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): April 2, 2020
• Primary Completion (ANTICIPATED): September 2, 2021
• Study Completion (ANTICIPATED): September 2, 2021

Study Registration Dates

• First Submitted: April 6, 2020
• First Submitted That Met QC Criteria: April 8, 2020
• First Posted (ACTUAL): April 9, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 9, 2020
• Last Update Submitted That Met QC Criteria: April 8, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Neurodevelopmental Disorders; Problem Behavior; Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
• Other Study ID Numbers: FUI/CTR/2020/2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No