Language DisorderNCT07128810
Parent Child Interaction Therapy vs Conventional Parent Led Therapy in Down Syndrome
A study testing Parent Child Interaction Therapy and Conventional Parent Led Therapy in people with Language Disorder, run by Riphah International University at 1 site in Pakistan.
Trial 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 more about this study
- Who is it for?
- Ages 1 year to 11 years
- Conditions the study is for
- Language Disorder
- What is being tested?
- Parent Child Interaction Therapy and Conventional Parent Led Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Mar 2025to 30 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Riphah International University Gulberg Green
Islamabad, Federal, 44000
About this study
Official title: Effects of Parent Child Interaction Therapy vs Conventional Parent Led Therapy in the Management of Language Disorders in Children With Down Syndrome
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.
- Conditions
- Language Disorder
- Being tested
- Parent Child Interaction Therapy, Conventional Parent Led Therapy
- Keywords
- Parent Child Interaction Therapy (PCIT), Conventional Parent Led Therapy, Down Syndrome, Language Disorder, Language Management
- Medical subject headings
- Language Disorders, Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent Child Interaction TherapyOther
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.
Conventional Parent Led TherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Parent Child Interaction Therapy | Experimental | Not described Receives: Other: Parent Child Interaction Therapy |
| Conventional Parent Led Therapy | Active comparator | Not described Receives: Other: Conventional Parent Led Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1st session, 6th session and 12th session (The Duration of each session is 45 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start15 Mar 2025
- Primary completion29 May 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Language DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Soabah Wasim, MS SLP, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07128810
- Sponsor's protocol ID
- 02114 Ishrat
- Status last verified
- Aug 2025
- First submitted
- 11 Jun 2025
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 31107508Agarwal 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 24127006Spellun 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 38117678Bittles 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 16857692Yamauchi 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
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Parent Child Interaction Therapy vs Conventional Parent Led Therapy in the Management of Language Disorders in Children With Down Syndrome
- ClinicalTrials.gov ID
- NCT07128810
- Acronym / sponsor ID
- 02114 Ishrat
- Conditions
- Language Disorder
- Keywords
- Parent Child Interaction Therapy (PCIT), Conventional Parent Led Therapy, Down Syndrome, Language Disorder, Language Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Mar 2025 (actual)
- Primary completion
- 29 May 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 19 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parent Child Interaction Therapy | Experimental | Other: Parent Child Interaction Therapy |
| Conventional Parent Led Therapy | Active comparator | Other: Conventional Parent Led Therapy |
Who may qualify
- Ages
- 1 year to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Children with Down Syndrome
- Parents
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parent Child Interaction TherapyParent 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. | Other | Parent Child Interaction Therapy |
| Conventional Parent Led TherapyParent 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. | Other | Conventional Parent Led Therapy |
Primary outcome
MacArthur-Bates Communicative Development Inventories (CDI) - Semantics composite
Time frame: 1st session, 6th session and 12th session (The Duration of each session is 45 minutes)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- BackgroundCronin SM. An effectiveness study of a parent-child interaction therapy with children with Down syndrome.
- Background: PubMed 31107508Roberts 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.
- Background: PubMed 24127006Agarwal 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.
- Background: PubMed 38117678Spellun 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.
- Background: PubMed 16857692Bittles 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.
- Background: PubMed 30503574Yamauchi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Soabah Wasim, MS SLP principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent Child Interaction Therapy and Conventional Parent Led Therapy in people with Language Disorder, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MacArthur-Bates Communicative Development Inventories (CDI) - Semantics composite (time frame: 1st session, 6th session and 12th session (The Duration of each session is 45 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07128810, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025.