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

29 de abril de 2026 actualizado por: Khizra Iqbal, Islamia University of Bahawalpur

Effectiveness of Parent-Mediated Intervention Combined With Positive Behavioral Support on Challenging Behaviors and Parenting Stress Among Children With Autism in South Punjab: A Quasi-Experimental Study

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.

Descripción general del estudio

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

80

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

      • Multiple Locations, Pakistán, 60000
        • The islamia university of Bahawalpur

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño

Acepta Voluntarios Saludables

No

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Cuidados de apoyo
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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.

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

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Aberrant Behavior Checklist (ABC)
Periodo de tiempo: From baseline (week 0), mid-intervention assessment (week 6), to post-intervention assessment at 12 weeks
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)
Periodo de tiempo: From baseline (week 0), mid-intervention assessment (week 6), to post-intervention assessment at 12 weeks
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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Adaptive functioning (VABS)
Periodo de tiempo: From baseline (week 0), mid-intervention assessment (week 6), to post-intervention assessment at 12 weeks
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.
From baseline (week 0), mid-intervention assessment (week 6), to post-intervention assessment at 12 weeks
Treatment Adherence
Periodo de tiempo: From baseline (week 0), mid-intervention assessment (week 6), to post-intervention assessment at 12 weeks
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.
From baseline (week 0), mid-intervention assessment (week 6), to post-intervention assessment at 12 weeks

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Khizra Iqbal, The Islamia University Bahawalpur, Punjab Pakistan

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de enero de 2026

Finalización primaria (Estimado)

1 de mayo de 2026

Finalización del estudio (Estimado)

1 de julio de 2026

Fechas de registro del estudio

Enviado por primera vez

22 de abril de 2026

Primero enviado que cumplió con los criterios de control de calidad

29 de abril de 2026

Publicado por primera vez (Actual)

6 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

6 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

29 de abril de 2026

Última verificación

1 de abril de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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