CompletedNot Applicable

Effectiveness of DIR/Floortime™ in Children With Intellectual Developmental Disorder

Pakistan24 participantsStarted 2026-03-16

Plain-language 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). 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).

Who can participate

Age range

4 Years – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Communication Skills

Timeframe: Baseline and Week 10

Socialization Skills

Timeframe: Baseline and Week 10

Daily Living Skills

Timeframe: Baseline and Week 10

Functional Emotional Development

Timeframe: Baseline and Week 10

Trial details

NCT IDNCT07758452

SponsorGIFT University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-07-15

View on ClinicalTrials.gov More Intellectual Developmental Disorder trials

Plain-language summary

Who can participate

Age range

4 Years – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.