Effectiveness of Parent-Mediated Intervention Combined With Positive Behavioral Support on Challenging Behaviors and Parenting Stress Among Children With Autism.

NCT07570550 | Active Not Recruiting DMC

• 1 other identifier: ECSFLLSDU2025-10.
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the effectiveness of a parent-mediated intervention combined with Positive Behavioral Support (PBS) in reducing challenging behaviors among children with autism and decreasing parenting stress in South Punjab, Pakistan. By equipping parents with PBS techniques, the intervention seeks to identify and manage behavioral triggers, thereby improving child behavior and reducing caregiver strain. There is a growing need for culturally adapted intervention programs in local languages such as Urdu and Seraiki, tailored to the socio-cultural context of Pakistani families. This study addresses this gap by providing indigenous evidence on a dual-component intervention (Parent-Mediated Intervention + PBS) designed specifically for the family structure and caregiving practices in South Punjab.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (2)

• Aberrant Behavior Checklist (ABC)

  The Aberrant Behavior Checklist (ABC) is a standardized caregiver-reported scale used to assess problem behaviors in children with developmental disorders. It includes 58 items across five domains: irritability, lethargy/social withdrawal, stereotypic behavior, hyperactivity, and inappropriate speech. Each item is rated on a 4-point scale (0-3), with total scores ranging from 0 to 174. Higher scores indicate greater severity of challenging behaviors, reflecting a worse outcome.

  From baseline (week 0), mid-intervention assessment (week 6), to post-intervention assessment at 12 weeks

• Parenting Stress Index (PSI)

  The Parenting Stress Index (PSI) is a standardized self-report measure assessing stress experienced by parents in relation to child-rearing. It includes domains such as parental distress, parent-child dysfunctional interaction, and difficult child characteristics. Scores typically range from 36 to 180 (short form). Higher scores indicate greater parenting stress, reflecting a worse outcome.

  From baseline (week 0), mid-intervention assessment (week 6), to post-intervention assessment at 12 weeks

Secondary Outcomes (2)

• Adaptive functioning (VABS)

  From baseline (week 0), mid-intervention assessment (week 6), to post-intervention assessment at 12 weeks

• Treatment Adherence

  From baseline (week 0), mid-intervention assessment (week 6), to post-intervention assessment at 12 weeks

Study Arms (1)

Parent-Mediated Intervention + Positive Behavioral Support (PMI + PBS)

EXPERIMENTAL

Participants in this arm will receive a structured parent-mediated intervention combined with Positive Behavioral Support (PBS). Parents will be trained to identify antecedents and consequences of challenging behaviors, implement behavior modification strategies, and reinforce adaptive behaviors in their children. The intervention will be delivered through weekly structured sessions over a period of 12 weeks. Each session will include psychoeducation, skills training, modeling, and guided practice. Parents will also be assigned home-based tasks to apply learned strategies in natural settings. The intervention will be delivered in local languages (Urdu and Seraiki) to ensure cultural relevance and comprehension.

Behavioral: Parent-Mediated Intervention + Positive Behavioral Support (PMI + PBS)

Interventions

Parent-Mediated Intervention + Positive Behavioral Support (PMI + PBS) BEHAVIORAL

Duration: 8-10 weeks intervention, 2 sessions per week (total 16-20 sessions) 1. Parent-Mediated Intervention (PMI) included Training parents in: Communication strategies Positive reinforcement Managing child behavior 2. Positive Behavioral Support (PBS) Functional behavior assessment Identifying triggers of behavior Teaching: Replacement behaviors Reinforcement techniques Behavior management plans

Parent-Mediated Intervention + Positive Behavioral Support (PMI + PBS)

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Presence of at least two moderate-to-severe "challenging behaviors" as reported by parents.
• Parents/caregivers who are the primary providers of daily care. Residents of South Punjab for the past 12 months.

You may not qualify if:

• Parents currently enrolled in other intensive behavioral training programs.

Sponsors & Collaborators

• Islamia University of Bahawalpur: lead

Study Sites (1)

The Islamia University of Bahawalpur

Multiple Locations, 60000, Pakistan

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Mannose-6-Phosphate Isomerase

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Aldose-Ketose Isomerases; Intramolecular Oxidoreductases; Isomerases; Enzymes; Enzymes and Coenzymes

Study Officials

• Khizra Iqbal

  The Islamia University Bahawalpur, Punjab Pakistan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D Scholar

Study Record Dates

• First Submitted: April 22, 2026
• First Posted: May 6, 2026
• Study Start: January 1, 2026
• Primary Completion: May 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)