NCT05749315

Brief Summary

The purpose of this study is to compare the play based therapy and functional communication training in speech-language delayed children 2-6 years old. This study will highlight the most effective intervention or therapy for Speech \& Language Delayed Children. The Randomized clinical trial study will be conducted in clinic, sehat medical complex, with children who will have the diagnosis of speech and language delay. These individual will be diagnose by a speech therapist (more than 2 years experience in the field) with PORTAGE guide to early education . A group of children will be given play based therapy and the other group of children will be given functional communication training. Participants' assessments of SLD will be made using the Portage Guide to Early Education. It will take three months of sessions 5 days in a week, lasting 20 to 30 minutes. The Progress of both therapies will be seen and assessed through structured questionnaire that which technique is more effective. The individual will be assess through Speech Questionnaire on base line and after 3 months session program.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 13, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 1, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

March 1, 2023

Status Verified

February 1, 2023

Enrollment Period

4 months

First QC Date

February 19, 2023

Last Update Submit

February 19, 2023

Conditions

Speech, Language Developmental Delay From Hearing Loss

Keywords

Play based therapyFunctional communication training

Outcome Measures

Primary Outcomes (1)

  • Speech Questionnaire

    The Speech Questionnaire: an Assessment of Functional Language Ability. International Rehabilitation Medicine.

    Change from baseline at 3rd Month

Study Arms (2)

Group A

ACTIVE COMPARATOR

Group A Speech Language Delayed Children

Other: Play Based Therapy

Group B

ACTIVE COMPARATOR

Group B Speech Language Delayed Children

Other: Functional Communication Training

Interventions

Play Based TherapyOTHER

Participants' assessments of SLD will be made using the Portage Guide to Early Education. It will take three months of sessions 5 days a week, lasting 20 to 30 minutes. The individual will be asses through Speech Questionnaire on base line and after 3 months session program. The Progress of both therapies will be seen that which technique is more effective.

Group A
Functional Communication TrainingOTHER

Participants' assessments of SLD will be made using the Portage Guide to Early Education. It will take three months of sessions 5 days a week, lasting 20 to 30 minutes. The individual will be asses through Speech Questionnaire on base line and after 3 months session program. The Progress of both therapies will be seen that which technique is more effective.

Group B

Eligibility Criteria

Age2 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Participants with comorbidity of behavioral disorder, Autism \& ADHD

You may not qualify if:

  • Patient with comorbidity of syndromes ( downs syndrome, treacher Collin syndrome, hunter syndrome , Williams Syndrome, kabuki syndrome etc )

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sehat Medical Complex, Lahore

Lahore, Punjab Province, 55201, Pakistan

RECRUITING

MeSH Terms

Conditions

Speech

Interventions

Play Therapy

Condition Hierarchy (Ancestors)

Verbal BehaviorCommunicationBehavior

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Momina Mehmood

    University of Lahore

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Imran Ghafoor

CONTACT

03344292887imran.ghafoor64@gamil.com

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
PRINCIPAL INVESTIGATOR
PI Title
Project Director

Study Record Dates

First Submitted

February 19, 2023

First Posted

March 1, 2023

Study Start

December 13, 2022

Primary Completion

April 1, 2023

Study Completion

May 1, 2023

Last Updated

March 1, 2023

Record last verified: 2023-02

Locations

PA(1)