Autism Spectrum Disorder (ASDDIR-ASDNCT07758465
Effectiveness of DIR/Floortime™ in Children With Autism Spectrum Disorder
A study testing DIR/Floortime and Standard therapy in people with Autism Spectrum Disorder (ASD, run by Fatima Tabassum at 1 site in Pakistan.
Trial summary
This randomized controlled trial evaluates the efficacy of Integrated DIR/Floortime™ in improving functional emotional development and adaptive behavior in children aged 4-12 years with Autism Spectrum Disorder (ASD). Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Autism Spectrum Disorder (ASD
- 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
- 14 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Feb 2026to 4 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 Autism Spectrum Disorder (ASD) according to DSM-5-TR criteria according to DSM-5-TR criteria.
- Mild to moderate ASD severity.
- Receiving routine therapeutic services.
- Eligible to participate in the 10-week DIR/Floortime™ intervention.
- Parent or legal guardian willing to provide written informed consent.
Who cannot join
- Severe Autism Spectrum Disorder that would prevent participation in the intervention.
- Severe visual, hearing, or physical impairments interfering with assessment 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 informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Integrated DIR/Floortime™ for Children With Autism Spectrum Disorder: A Randomized Controlled Trial
This randomized controlled trial evaluates the efficacy of Integrated DIR/Floortime™ in improving functional emotional development and adaptive behavior in children aged 4-12 years with Autism Spectrum Disorder (ASD). Participants are randomly assigned to either an intervention group receiving DIR/Floortime™ in addition to their ongoing standard therapies or a control group receiving standard therapies alone. Functional emotional development is assessed using the Functional Emotional Assessment Scale (FEAS), while adaptive behavior is evaluated using the Vineland Adaptive Behavior Scales (VABS). The study aims to determine whether integrating DIR/Floortime™ leads to greater improvements in emotional, social, communication, and adaptive functioning compared with standard interventions alone.
Read the detailed description
Autism Spectrum Disorder (ASD) is a neurodevelopmental condition that significantly affect emotional development, communication, and social interaction. Although conventional interventions target specific developmental domains, many children continue to experience challenges in functional emotional capacities and daily living skills.
Developmental, Individual-differences, Relationship-based (DIR)/Floortime™ is a relationship-based intervention that promotes emotional regulation, communication, social engagement, and higher-order thinking through child-led, developmentally appropriate interactions. This study investigates the effectiveness of integrating DIR/Floortime™ with standard therapeutic services.
This study uses a parallel-group randomized controlled design. Eligible children aged 4-12 years diagnosed with ASD are randomly assigned to either an intervention group receiving DIR/Floortime™ plus standard therapies or a control group receiving standard therapies alone. Outcomes are measured before and after the intervention using the Functional Emotional Assessment Scale (FEAS) and the Vineland Adaptive Behavior Scales (VABS). The findings are expected to contribute evidence regarding the effectiveness of DIR/Floortime™ in improving functional emotional development and adaptive behavior among children with ASD and IDD.
- Conditions
- Autism Spectrum Disorder (ASD
- Being tested
- DIR/Floortime, Standard therapy
- Keywords
- DIR Floortime, Developmental Individual-differences Relationship-based Model, VABS, FEAS, Autism Spectrum disorder
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DIR/FloortimeBehavioural
Participants received Integrated DIR/Floortime™ intervention for 10 weeks in addition to their ongoing standard therapies. The intervention focused on promoting functional emotional development, communication, social interaction, and adaptive functioning through child-led, relationship-based sessions conducted according to the DIR/Floortime™ model.
Standard therapyBehavioural
Participants continued to receive routine standard therapeutic services without the addition of DIR/Floortime™ during the 10-week study period.
| Study group | Role | What they receive |
|---|---|---|
| DIR/Floortime + Standard Therapy | Experimental | Participants received Integrated DIR/Floortime™ in addition to their ongoing standard therapies. Receives: Behavioral: DIR/Floortime |
| Standard Therapy | Active comparator | Participants continued to receive standard therapies without DIR/Floortime Receives: Behavioral: Standard therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
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 start15 Feb 2026
- Primary completion20 Jul 2026
- Study completion4 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum Disorder (ASDStudies 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
- Model description
- Participants were randomly assigned to either an intervention group receiving DIR/Floortime™ in addition to standard therapies or a control group receiving standard therapies alone. Both groups were followed concurrently and assessed at baseline and post-intervention.
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fatima Tabassum
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fatima Tabassum, GIFT University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07758465
- Sponsor's protocol ID
- GIFT/PSY/MS/2025/001
- Acronym
- DIR-ASD
- 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 because the study involves confidential data from children, 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
- Efficacy of Integrated DIR/Floortime™ for Children With Autism Spectrum Disorder: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07758465
- Acronym / sponsor ID
- DIR-ASD / GIFT/PSY/MS/2025/001
- Conditions
- Autism Spectrum Disorder (ASD
- Keywords
- DIR Floortime, Developmental Individual-differences Relationship-based Model, VABS, FEAS, Autism Spectrum disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Fatima TabassumUniversity, hospital or other
- Study start
- 15 Feb 2026 (actual)
- Primary completion
- 20 Jul 2026 (actual)
- Study completion
- 4 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 evaluates the efficacy of Integrated DIR/Floortime™ in improving functional emotional development and adaptive behavior in children aged 4-12 years with Autism Spectrum Disorder (ASD). Participants are randomly assigned to either an intervention group receiving DIR/Floortime™ in addition to their ongoing standard therapies or a control group receiving standard therapies alone. Functional emotional development is assessed using the Functional Emotional Assessment Scale (FEAS), while adaptive behavior is evaluated using the Vineland Adaptive Behavior Scales (VABS). The study aims to determine whether integrating DIR/Floortime™ leads to greater improvements in emotional, social, communication, and adaptive functioning compared with standard interventions alone.
Detailed description
Autism Spectrum Disorder (ASD) is a neurodevelopmental condition that significantly affect emotional development, communication, and social interaction. Although conventional interventions target specific developmental domains, many children continue to experience challenges in functional emotional capacities and daily living skills.
Developmental, Individual-differences, Relationship-based (DIR)/Floortime™ is a relationship-based intervention that promotes emotional regulation, communication, social engagement, and higher-order thinking through child-led, developmentally appropriate interactions. This study investigates the effectiveness of integrating DIR/Floortime™ with standard therapeutic services.
This study uses a parallel-group randomized controlled design. Eligible children aged 4-12 years diagnosed with ASD are randomly assigned to either an intervention group receiving DIR/Floortime™ plus standard therapies or a control group receiving standard therapies alone. Outcomes are measured before and after the intervention using the Functional Emotional Assessment Scale (FEAS) and the Vineland Adaptive Behavior Scales (VABS). The findings are expected to contribute evidence regarding the effectiveness of DIR/Floortime™ in improving functional emotional development and adaptive behavior among children with ASD and IDD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomly assigned to either an intervention group receiving DIR/Floortime™ in addition to standard therapies or a control group receiving standard therapies alone. Both groups were followed concurrently and assessed at baseline and post-intervention.
| Arm | Type | Receives |
|---|---|---|
| DIR/Floortime + Standard Therapy | Experimental | Behavioral: DIR/FloortimeParticipants received Integrated DIR/Floortime™ in addition to their ongoing standard therapies. |
| Standard Therapy | Active comparator | Behavioral: Standard therapyParticipants continued to receive standard therapies without DIR/Floortime |
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 Autism Spectrum Disorder (ASD) according to DSM-5-TR criteria according to DSM-5-TR criteria.
- Mild to moderate ASD severity.
- Receiving routine therapeutic services.
- Eligible to participate in the 10-week DIR/Floortime™ intervention.
Key exclusion criteria (6 listed)
- Severe Autism Spectrum Disorder that would prevent participation in the intervention.
- Severe visual, hearing, or physical impairments interfering with assessment 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/FloortimeParticipants received Integrated DIR/Floortime™ intervention for 10 weeks in addition to their ongoing standard therapies. The intervention focused on promoting functional emotional development, communication, social interaction, and adaptive functioning through child-led, relationship-based sessions conducted according to the DIR/Floortime™ model. | Behavioural | DIR/Floortime + Standard Therapy |
| Standard therapyParticipants continued to receive routine standard therapeutic services without the addition of DIR/Floortime™ during the 10-week study period. | Behavioural | Standard Therapy |
Primary outcome
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.
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.
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 because the study involves confidential data from children, and participant privacy and confidentiality will be protected in accordance with institutional ethical approval and informed consent.
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 Autism Spectrum Disorder (ASD, run by Fatima Tabassum 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?
Socialization 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.