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CompletedNCT07128810Updated Aug 19, 2025

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

An interventional study of Parent Child Interaction Therapy and Conventional Parent Led Therapy in Language Disorder, sponsored by Riphah International University. Completed at 1 site in Pakistan. Open to participants aged 1 Year to 11 Years. Per ClinicalTrials.gov, last updated 2025-08-19.

Sponsored by Riphah International University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
1 Year to 11 Years
Sex
All
01

Study 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

Read the detailed description

The most common type of chromosomal defect is Down syndrome (DS), Incidence for Down syndrome in developed countries is 1 of 700 births, however comparatively there is higher incidence in developing countries like Pakistan as one in every 300 births down syndrome occurs. Children with Down syndrome (DS) are prone to learning disorders, morphological unique features and health problems that can include hematological disorders or cardiac problems. Children with down syndrome have unique facial characteristics which can lead difficulties with the biological development of face due to various inheritance factors.

There are significant language delays that are observed among Down syndrome children that can affect their communication ability. The children with Down syndrome typically have a unique language profile in which they have strength in the receptive vocabulary, but show weakness in their expressive language and depth of word knowledge. These children often tend to have more challenges in phonology, morphology, and syntax, whereas the use of language that includes pragmatics are less impaired, but they are still weaker comparatively to the typical developing children.

Children with Down syndrome commonly experience language disorders that affect both expressive and receptive abilities. The language management is essential in the early intervention of Children with Down Syndrome that focuses on many factors, including language therapy that enhances vocabulary and expression. engaging parents as it is vital in order to educate them and provide supportive techniques that can lead to better outcomes.

There are Two prominent interventions for language problems are Parent-Child Interaction Therapy (PCIT) and Clinician-Directed Therapy (CDT). The main focus of PCIT is to enhance the quality of the parent-child relationship and improving behavioral interactions through structured coaching. The aim of this method to create a more supportive and engaging environment for the child's language development. Where as comparatively CDT is direct therapist-led sessions that are designed to target specific language skills based on structured activities and exercises.

PCIT is structured, behavior-change intervention for young children between the ages of 2 and 7 years helping parents adopt less directive, positively engaging approaches that may improve parent-reported child communication skills. PCIT includes two stages; the first one is Child-Directed Interaction (CDI) for enhancing positive interactions and reinforcing desired behaviors, while the second stage is based on effective discipline strategies, Parent- Directed Interaction (PDI). From recent evidence it was reported that parent interaction skills and children's language the outcomes are significantly improved in post PCIT cases.

The Child-Directed Interaction (CDI) phase of Parent-Child Interaction Therapy focuses on building positive relationships, mainly for children with delayed language development. In this phase, parents engage in child-led play, using PRIDE skills like reflecting their child's phrases and providing descriptive language to positively enhance communication and reduce control. The Parent-Directed Interaction phase then shifts to teaching parents effective behavior management strategies. This includes setting clear expectations, using consistent discipline, and applying tools like timeouts and positive reinforcement.

Parents practice these techniques during therapy sessions, receiving feedback through video analysis, which helps them refine their approach and build confidence. As the interactions become more complex, the therapist's support gradually lessens, allowing parents to independently apply what they've learned.

In contrast conventional parent-mediated therapy is done in unstructured environment in which parents are active agents in the therapeutic strategies to enhance their child's communications and social skills. This approach equips parents with the competency to facilitate learning during daily interactions, which in turn helps the child achieve better developmental outcomes.

This parent-mediated therapy efficiently trains parents to make use of techniques that will contribute to the development of impaired children's language. Research has shown the influence of this strategy on receptive and expressive language, implying that a long-lasting effect can be accounted for in these studies of such interventions over some time.

Comparing the effects of Parent-Child Interaction Therapy with conventional parent-led therapy for managing language disorders in children with Down Syndrome will help optimize the intervention strategies. PCIT is more systematic and evidence-based, focusing on enhancing parent-child interactions through specific phases that have been shown to improve communication skills and behavioral outcomes. Conventional parent-led therapies provide flexible, individualized techniques for vocabulary and sentence structure building through daily interactions. The two methods are compared to determine which one will more effectively support language development, taking into account the structured framework of PCIT and the adaptability of traditional therapies. This comparison is crucial for clinical practice and will help guide families in selecting the intervention that best meets their child's specific needs.

02

Conditions studied

  • Language Disorder

Keywords

  • Parent Child Interaction Therapy (PCIT)
  • Conventional Parent Led Therapy
  • Down Syndrome
  • Language Disorder
  • Language Management
03

In context

Language Disorders

84 studies on the registry are indexed under Language Disorders; 18 are open to participants now.

This study's enrollment of 16 is below the median of 51 across 66 interventional studies indexed under Language Disorders.

Browse Language Disorders studies →

Lead sponsor

Riphah International University is the lead sponsor of 2,193 studies on the registry; 650 are open to participants now.

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

04

Who can participate

Ages eligible
1 Year to 11 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

- 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    Parent Child Interaction Therapy

    Other: Parent Child Interaction Therapy

  • Active comparator
    Conventional Parent Led Therapy

    Other: Conventional Parent Led Therapy

Interventions

  • OtherParent Child Interaction Therapy

    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.

  • OtherConventional Parent Led Therapy

    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.

06

What researchers measure

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.

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

07

Study locations

1 site
  • Riphah International University Gulberg Green
    Islamabad, Federal 44000, Pakistan
08

References and documents

Publications

  • Cronin SM. An effectiveness study of a parent-child interaction therapy with children with Down syndrome.
  • 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. PubMed 31107508 ↗
  • 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. PubMed 24127006 ↗
  • 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. PubMed 38117678 ↗
  • 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. PubMed 16857692 ↗
  • 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. PubMed 30503574 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07128810
Responsible party
Sponsor
First posted
Aug 19, 2025
Start date
Mar 15, 2025
Primary completion
May 29, 2025
Completion
May 30, 2025
Last update
Aug 19, 2025

Study contacts

Soabah Wasim, MS SLP
principal investigator · Riphah International University

Oversight

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

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This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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