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

NCT04339153 | Unknown

• 1 other identifier: FUI/CTR/2020/2
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Autism Spectrum Disorder; Disruptive Behaviours

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Vineland Adaptive Behavior Scales (Vineland-II; Sparrow, Cicchetti, & Balla, 2005)

  24 weeks

• Home Situations Questionnaire Disorder (HSQ; Chowdhury et al, 2016)

  24 weeks

• Clinical Global Impressions - Improvement Scale (CGI; Guy 1976)

  24 weeks

Study Arms (2)

Parent Training (PT)

EXPERIMENTAL

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

Parent Education (PE)

NO INTERVENTION

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.

Interventions

Parent Training for Disruptive Behaviours BEHAVIORAL

Critically, PT also involves education about autism during the initial sessions, and thus benefits of PT are inferred to come from the specific training.

Parent Training (PT)

Eligibility Criteria

• Age: 3 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Foundation University Islamabad: lead

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Nadia Shafique, Dr

  FUI

  PRINCIPAL INVESTIGATOR

• Nasim Chaudhary, Dr. Prof.

  FUI

  STUDY CHAIR

• Nusrat Hussain, Dr. Prof.

  University of Manchester

  PRINCIPAL INVESTIGATOR

• Jumana Ahmad

  Greenwich University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nadia Shafique, PhD

CONTACT

03335513401; nadiashafique17@gmail.com

Nasim Chaudhry, Dr. Prof.

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: April 6, 2020
• First Posted: April 9, 2020
• Study Start: April 2, 2020
• Primary Completion: September 2, 2021
• Study Completion: September 2, 2021
• Last Updated: April 9, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share