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Active, not recruitingNCT07570550Updated May 6, 2026

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

An interventional study of Parent-Mediated Intervention + Positive Behavioral Support (PMI + PBS) in Autism Spectrum Disorder, sponsored by Islamia University of Bahawalpur. Active, not recruiting at 1 site in Pakistan. Open to participants aged 3 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-05-06.

Sponsored by Islamia University of Bahawalpur · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by May 2026, 5 months ago, but the record still lists the study as active, not recruiting.
  • Registered 3 months after the study started (first participant enrolled Jan 2026, registered Apr 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Not applicable
Ages
3 Years to 12 Years
Sex
All
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Study 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.

Read the detailed description

This quasi-experimental study is designed to examine the effectiveness of a combined Parent-Mediated Intervention (PMI) and Positive Behavioral Support (PBS) program in managing challenging behaviors among children diagnosed with autism spectrum disorder and reducing parenting stress among their caregivers in South Punjab, Pakistan.

Children with autism often exhibit challenging behaviors such as aggression, self-injury, and non-compliance, which significantly increase caregiver burden and negatively impact family functioning. In low-resource settings like South Punjab, access to structured behavioral interventions is limited, and most available programs are not culturally or linguistically adapted.

The intervention program in this study integrates parent training (PMI) with evidence-based behavioral strategies (PBS). Parents will be trained to identify antecedents and consequences of challenging behaviors, implement behavior modification techniques, and reinforce adaptive behaviors in natural home settings. The intervention will be delivered in local languages (Urdu and Seraiki) to enhance accessibility and comprehension.

Participants will be divided into intervention and control groups. The intervention group will receive the combined PMI + PBS program, while the control group will receive treatment as usual. Standardized measures will be used to assess changes in child behavior and parenting stress before and after the intervention.

The findings of this study are expected to provide culturally relevant evidence for scalable, family-based interventions in Pakistan and contribute to improving the quality of life of children with autism and their caregivers.

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Conditions studied

  • Autism Spectrum Disorder
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In context

Autism Spectrum Disorder

1,727 studies on the registry are indexed under Autism Spectrum Disorder; 504 are open to participants now.

This study's planned enrollment of 80 is above the median of 52 across 1,371 interventional studies indexed under Autism Spectrum Disorder.

Browse Autism Spectrum Disorder studies →

Lead sponsor

Islamia University of Bahawalpur is the lead sponsor of 15 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
3 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria: Children aged 3 to 12 years with a confirmed diagnosis of ASD (based on DSM-5 criteria).

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.

Exclusion Criteria: Children with severe comorbid physical disabilities (e.g., total blindness or deafness) that prevent participation in standard PBS activities.

Parents currently enrolled in other intensive behavioral training programs.

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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
80 participants (estimated)

Study arms

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

    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

  • BehavioralParent-Mediated Intervention + Positive Behavioral Support (PMI + PBS)

    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

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What researchers measure

Primary outcomes

  1. 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.

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

  2. 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.

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

Secondary outcomes

  1. Adaptive functioning (VABS)

    The Vineland Adaptive Behavior Scales (VABS) is a standardized instrument used to assess adaptive functioning, including communication, daily living skills, socialization, and motor skills. Scores are reported as standard scores with a mean of 100 and a standard deviation of 15, typically ranging from approximately 20 to 160. Higher scores indicate better adaptive functioning, reflecting a better outcome.

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

  2. Treatment Adherence

    Treatment adherence will be measured as the percentage of intervention sessions attended by parents out of the total number of scheduled sessions. Adherence will be calculated as a percentage ranging from 0% to 100%. Higher percentages indicate greater adherence to the intervention protocol, reflecting a better outcome.

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

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Study locations

1 site
  • The Islamia University of Bahawalpur
    Multiple Locations, 60000, Pakistan
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07570550
Lead sponsor
Islamia University of Bahawalpur
Responsible party
Khizra Iqbal (Ph.D Scholar, The Islamia University of Bahawalpur, Khawaja Fareed CampusDr) — Principal investigator
First posted
May 6, 2026
Start date
Jan 1, 2026
Primary completion
May 1, 2026 (estimated)
Completion
Jul 2026 (estimated)
Last update
May 6, 2026

Study contacts

Khizra Iqbal
principal investigator · The Islamia University Bahawalpur, Punjab Pakistan

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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