Parent Child Interaction Therapy vs Conventional Parent Led Therapy in Down Syndrome

NCT07128810 | Completed

• 1 other identifier: 02114 Ishrat
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the effect of Parent child interaction therapy vs Conventional Parent Led Therapy in the management of language disorders in Children with Down Syndrome

Conditions

Language Disorder

Keywords

Parent Child Interaction Therapy (PCIT); Conventional Parent Led Therapy; Down Syndrome; Language Disorder; Language Management

Outcome Measures

Primary Outcomes (1)

• MacArthur-Bates Communicative Development Inventories (CDI) - Semantics composite

  The MacArthur-Bates Communicative Development Inventories (CDI) is a standardized, parent-report tool used to assess early sementic development in children. It consist of two sections: word comprehension and word production. At the baseline (1st session), this tool is administered to establish the child's initial vocabulary level. At the midpoint (6th session), scores are calculated based on the number of words the child understands and produces, allowing for measurement of progress. At the end of the intervention (12th session), the CDI is administered again to evaluate changes in vocabulary comprehension and production. The Duration of each session was 45mins This tool provides a reliable means of tracking language acquisition and measuring the effectiveness of the intervention over time.

  1st session, 6th session and 12th session (The Duration of each session is 45 minutes)

Study Arms (2)

Parent Child Interaction Therapy

EXPERIMENTAL

Other: Parent Child Interaction Therapy

Conventional Parent Led Therapy

ACTIVE COMPARATOR

Other: Conventional Parent Led Therapy

Interventions

Parent Child Interaction Therapy OTHER

Parent was trained in a structured way during two phases of PCIT that are Phase 1: Child Directed Intervention and Phase 2: Parent Directed Intervention to encourage Language Development with frequency of sessions as 12 sessions; minimum 30 mins each day, 3x per week.

Parent Child Interaction Therapy

Conventional Parent Led Therapy OTHER

Parent was trained in an unstructured way by using different language development strategies (Imitation, Focused Stimulations, Milieu Teaching, and others) to encourage Language Development with frequency of session as 12 sessions; minimum 30 mins each day, 3x per week.

Conventional Parent Led Therapy

Eligibility Criteria

• Age: 1 Year - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children with Down Syndrome
• Children diagnosed with Down Syndrome
• Children that have acquired pre linguistic skills like eye contact, non-verbal imitation, joint attention, turn taking
• Children having nonverbal intentional communication.
• Children having core receptive vocabulary of 50 words.
• Parents
• Mother or father of a child with Down syndrome.

You may not qualify if:

• \- Children with Down Syndrome
• Children with co morbid conditions like hearing and visual impairment.
• Child concurrently enrolled in other Speech therapy programs. Parents
• Parents previously trained for PCIT.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Riphah International University Gulberg Green

Islamabad, Federal, 44000, Pakistan

Location

Related Publications (6)

• Cronin SM. An effectiveness study of a parent-child interaction therapy with children with Down syndrome.

  BACKGROUND

• Roberts MY, Curtis PR, Sone BJ, Hampton LH. Association of Parent Training With Child Language Development: A Systematic Review and Meta-analysis. JAMA Pediatr. 2019 Jul 1;173(7):671-680. doi: 10.1001/jamapediatrics.2019.1197.

  PMID: 31107508 BACKGROUND

• Agarwal Gupta N, Kabra M. Diagnosis and management of Down syndrome. Indian J Pediatr. 2014 Jun;81(6):560-7. doi: 10.1007/s12098-013-1249-7. Epub 2013 Oct 15.

  PMID: 24127006 BACKGROUND

• Spellun A, Harstad E, Hojlo M, Milliken A, Pawlowski K, Sideridis G, Baumer N. Cross-Sectional Analysis of Caregiver-Reported Expressive Language Profiles and Associated Covariates in Individuals with Down Syndrome. J Dev Behav Pediatr. 2024 Jan 1;45(1):e63-e71. doi: 10.1097/DBP.0000000000001236. Epub 2023 Dec 20.

  PMID: 38117678 BACKGROUND

• Bittles AH, Bower C, Hussain R, Glasson EJ. The four ages of Down syndrome. Eur J Public Health. 2007 Apr;17(2):221-5. doi: 10.1093/eurpub/ckl103. Epub 2006 Jul 19.

  PMID: 16857692 BACKGROUND

• Yamauchi Y, Aoki S, Koike J, Hanzawa N, Hashimoto K. Motor and cognitive development of children with Down syndrome: The effect of acquisition of walking skills on their cognitive and language abilities. Brain Dev. 2019 Apr;41(4):320-326. doi: 10.1016/j.braindev.2018.11.008. Epub 2018 Nov 28.

  PMID: 30503574 BACKGROUND

MeSH Terms

Conditions

Language Disorders; Down Syndrome

Condition Hierarchy (Ancestors)

Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Intellectual Disability; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn

Study Officials

• Soabah Wasim, MS SLP

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 11, 2025
• First Posted: August 19, 2025
• Study Start: March 15, 2025
• Primary Completion: May 29, 2025
• Study Completion: May 30, 2025
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)