Intellectual Developmental DisorderDIR-IDDNCT07758452
Effectiveness of DIR/Floortime™ in Children With Intellectual Developmental Disorder
A study testing DIR/Floortime™ and Standard therapy in people with Intellectual Developmental Disorder, run by GIFT University at 1 site in Pakistan.
Trial summary
This randomized controlled trial aims to evaluate the effectiveness of Integrated Developmental, Individual-differences, Relationship-based (DIR)/Floortime™ intervention in improving functional emotional development and adaptive behavior in children with Intellectual Developmental Disorder (IDD). Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Intellectual Developmental Disorder
- What is being tested?
- DIR/Floortime™ and Standard therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 sitePakistan
- Study dates
- 16 Mar 2026to 1 Aug 2026
- 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 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 4-12 years.
- Clinical diagnosis of Intellectual Developmental Disorder (IDD) according to DSM-5-TR criteria.
- Mild to moderate intellectual developmental impairment.
- Receiving routine therapeutic services.
- Able to participate in the 10-week DIR/Floortime™ intervention and study assessments.
- Written informed consent obtained from a parent or legal guardian.
Who cannot join
- Profound or severe Intellectual Developmental Disorder preventing meaningful participation in the intervention.
- Severe visual, hearing, or physical impairments that would interfere with assessments or intervention.
- Major neurological or genetic disorders that could affect study participation.
- Serious medical or psychiatric conditions requiring intensive treatment.
- Participation in another intervention study during the study period.
- Parent or legal guardian unwilling to provide written informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of DIR/Floortime™ in Children With Intellectual Developmental Disorder: A Randomized Controlled Trial
This randomized controlled trial aims to evaluate the effectiveness of Integrated Developmental, Individual-differences, Relationship-based (DIR)/Floortime™ intervention in improving functional emotional development and adaptive behavior in children with Intellectual Developmental Disorder (IDD). Participants aged 4-12 years will be randomly assigned to receive either DIR/Floortime™ in addition to standard therapy or standard therapy alone for 10 weeks. Outcomes will be assessed using the Functional Emotional Assessment Scale (FEAS) and the Vineland Adaptive Behavior Scales (VABS).
Read the detailed description
Intellectual Developmental Disorder (IDD) is characterized by significant limitations in intellectual functioning and adaptive behavior, affecting conceptual, social, and practical skills. Although conventional therapeutic interventions support developmental progress, many children continue to experience challenges in communication, social interaction, daily living skills, and functional emotional development. The Developmental, Individual-differences, Relationship-based (DIR)/Floortime™ model is a relationship-based intervention designed to enhance emotional, social, and developmental capacities through child-led interactions.
This study is a parallel-group randomized controlled trial evaluating the effectiveness of Integrated DIR/Floortime™ in children with IDD. Participants aged 4-12 years will be randomly assigned to either an experimental group receiving DIR/Floortime™ in addition to standard therapy or a control group receiving standard therapy alone. The intervention will be delivered over a period of 10 weeks.
The primary outcomes include communication, socialization, daily living skills, and functional emotional development. These outcomes will be measured using the Vineland Adaptive Behavior Scales (VABS) and the Functional Emotional Assessment Scale (FEAS) at baseline and after completion of the 10-week intervention. The findings will contribute to the evidence regarding the effectiveness of DIR/Floortime™ for children with Intellectual Developmental Disorder.
- Conditions
- Intellectual Developmental Disorder
- Being tested
- DIR/Floortime™, Standard therapy
- Keywords
- Intellectual developmental disorder, FEAS, VABS, IDD, DIR/Floortime
- Medical subject headings
- Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DIR/Floortime™Behavioural
Integrated Developmental, Individual-differences, Relationship-based (DIR)/Floortime™ intervention delivered for 10 weeks in addition to standard therapy
Standard therapyBehavioural
Routine therapeutic services provided without DIR/Floortime™ during the 10-week study period.
| Study group | Role | What they receive |
|---|---|---|
| DIR/Floortime + Standard Therapy | Experimental | Participants receive Integrated DIR/Floortime™ in addition to their routine standard therapeutic services for 10 weeks. Receives: Behavioral: DIR/Floortime™ |
| Standard Therapy | Active comparator | Participants continue to receive routine standard therapeutic services without the addition of DIR/Floortime™ for 10 weeks. Receives: Behavioral: Standard therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Communication Skills
Change in Communication Skills measured using the Vineland Adaptive Behavior Scales, Third Edition (VABS-3), Communication domain Growth Scale Values (GSVs). GSVs range from 10 to 197, with higher scores indicating better adaptive functioning.
Measured: Baseline and Week 10
Socialization Skills
Change in Socialization Skills measured using the Vineland Adaptive Behavior Scales, Third Edition (VABS-3), Socialization domain Growth Scale Values (GSVs). GSVs range from 10 to 197, with higher scores indicating better adaptive functioning.
Measured: Baseline and Week 10
Daily Living Skills
Change in Daily Living Skills measured using the Vineland Adaptive Behavior Scales, Third Edition (VABS-3), Daily Living Skills domain Growth Scale Values (GSVs). GSVs range from 10 to 197, with higher scores indicating better adaptive functioning.
Measured: Baseline and Week 10
Functional Emotional Development
Change in functional emotional development measured using the Functional Emotional Assessment Scale (FEAS). FEAS items are scored from 0 to 2, with higher scores indicating better functional emotional development. Symbolic, Sensory, and Examiner scores are assessed.
Measured: Baseline and Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study start16 Mar 2026
- Primary completion15 Jul 2026
- Study completion1 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intellectual Developmental 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
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- GIFT University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatima Tabassum, GIFT University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07758452
- Sponsor's protocol ID
- GIFT/PSY/MS/2025/001B
- Acronym
- DIR-IDD
- Status last verified
- Aug 2026
- First submitted
- 6 Aug 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data (IPD) will not be shared. The study involves confidential data from children with Intellectual Developmental Disorder, and participant privacy and confidentiality will be protected in accordance with institutional ethical approval and informed consent.
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of DIR/Floortime™ in Children With Intellectual Developmental Disorder: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07758452
- Acronym / sponsor ID
- DIR-IDD / GIFT/PSY/MS/2025/001B
- Conditions
- Intellectual Developmental Disorder
- Keywords
- Intellectual developmental disorder, FEAS, VABS, IDD, DIR/Floortime
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- GIFT UniversityUniversity, hospital or other
- Study start
- 16 Mar 2026 (actual)
- Primary completion
- 15 Jul 2026 (actual)
- Study completion
- 1 Aug 2026 (actual)
- First posted
- 11 Aug 2026 (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.
This randomized controlled trial aims to evaluate the effectiveness of Integrated Developmental, Individual-differences, Relationship-based (DIR)/Floortime™ intervention in improving functional emotional development and adaptive behavior in children with Intellectual Developmental Disorder (IDD). Participants aged 4-12 years will be randomly assigned to receive either DIR/Floortime™ in addition to standard therapy or standard therapy alone for 10 weeks. Outcomes will be assessed using the Functional Emotional Assessment Scale (FEAS) and the Vineland Adaptive Behavior Scales (VABS).
Detailed description
Intellectual Developmental Disorder (IDD) is characterized by significant limitations in intellectual functioning and adaptive behavior, affecting conceptual, social, and practical skills. Although conventional therapeutic interventions support developmental progress, many children continue to experience challenges in communication, social interaction, daily living skills, and functional emotional development. The Developmental, Individual-differences, Relationship-based (DIR)/Floortime™ model is a relationship-based intervention designed to enhance emotional, social, and developmental capacities through child-led interactions.
This study is a parallel-group randomized controlled trial evaluating the effectiveness of Integrated DIR/Floortime™ in children with IDD. Participants aged 4-12 years will be randomly assigned to either an experimental group receiving DIR/Floortime™ in addition to standard therapy or a control group receiving standard therapy alone. The intervention will be delivered over a period of 10 weeks.
The primary outcomes include communication, socialization, daily living skills, and functional emotional development. These outcomes will be measured using the Vineland Adaptive Behavior Scales (VABS) and the Functional Emotional Assessment Scale (FEAS) at baseline and after completion of the 10-week intervention. The findings will contribute to the evidence regarding the effectiveness of DIR/Floortime™ for children with Intellectual Developmental Disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DIR/Floortime + Standard Therapy | Experimental | Behavioral: DIR/Floortime™Participants receive Integrated DIR/Floortime™ in addition to their routine standard therapeutic services for 10 weeks. |
| Standard Therapy | Active comparator | Behavioral: Standard therapyParticipants continue to receive routine standard therapeutic services without the addition of DIR/Floortime™ for 10 weeks. |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children aged 4-12 years.
- Clinical diagnosis of Intellectual Developmental Disorder (IDD) according to DSM-5-TR criteria.
- Mild to moderate intellectual developmental impairment.
- Receiving routine therapeutic services.
- Able to participate in the 10-week DIR/Floortime™ intervention and study assessments.
Key exclusion criteria (6 listed)
- Profound or severe Intellectual Developmental Disorder preventing meaningful participation in the intervention.
- Severe visual, hearing, or physical impairments that would interfere with assessments or intervention.
- Major neurological or genetic disorders that could affect study participation.
- Serious medical or psychiatric conditions requiring intensive treatment.
- Participation in another intervention study during the study period.
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 |
|---|---|---|
| DIR/Floortime™Integrated Developmental, Individual-differences, Relationship-based (DIR)/Floortime™ intervention delivered for 10 weeks in addition to standard therapy | Behavioural | DIR/Floortime + Standard Therapy |
| Standard therapyRoutine therapeutic services provided without DIR/Floortime™ during the 10-week study period. | Behavioural | Standard Therapy |
Primary outcome
Communication Skills
Time frame: Baseline and Week 10
Change in Communication Skills measured using the Vineland Adaptive Behavior Scales, Third Edition (VABS-3), Communication domain Growth Scale Values (GSVs). GSVs range from 10 to 197, with higher scores indicating better adaptive functioning.
Socialization Skills
Time frame: Baseline and Week 10
Change in Socialization Skills measured using the Vineland Adaptive Behavior Scales, Third Edition (VABS-3), Socialization domain Growth Scale Values (GSVs). GSVs range from 10 to 197, with higher scores indicating better adaptive functioning.
Daily Living Skills
Time frame: Baseline and Week 10
Change in Daily Living Skills measured using the Vineland Adaptive Behavior Scales, Third Edition (VABS-3), Daily Living Skills domain Growth Scale Values (GSVs). GSVs range from 10 to 197, with higher scores indicating better adaptive functioning.
Functional Emotional Development
Time frame: Baseline and Week 10
Change in functional emotional development measured using the Functional Emotional Assessment Scale (FEAS). FEAS items are scored from 0 to 2, with higher scores indicating better functional emotional development. Symbolic, Sensory, and Examiner scores are assessed.
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 13 Aug 2026.
- Individual participant dataSharing planned: No. Individual Participant Data (IPD) will not be shared. The study involves confidential data from children with Intellectual Developmental Disorder, and participant privacy and confidentiality will be protected in accordance with institutional ethical approval and informed consent.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DIR/Floortime™ and Standard therapy in people with Intellectual Developmental Disorder, run by GIFT 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 6 inclusion and 6 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 13 Aug 2026. 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?
Communication Skills (time frame: Baseline and Week 10). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Aug 2026.