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IRCT20251213068303N1 IRCT 2026-06-01 Tabriz University of Medical Sciences The effect of a DIR/Floortime approach on sibling interaction and parental quality of life in families of children with autism spectrum disorder The effect of a DIR/Floortime approach on sibling interaction and parental quality of life in families of children with autism spectrum disorder: A Randomized Clinical Trial 2026-05-23 anticipated 38 Complete https://irct.ir/trial/88171 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization will be performed using a Randomized Block Design to ensure that the groups are balanced in terms of the key variable (gender). It should be noted that the key background variables in this study are age, symptom severity, and gender. To control for the effect of age, only children with Autism Spectrum Disorder aged 3 to 5 years will be included in the study, while children aged 5 to 8 years will be excluded. To control for the effect of symptom severity, children with mild to moderate symptoms will be included, whereas children with severe symptoms will be excluded. To control for the effect of gender, blocking will be performed based on the child’s gender (boy or girl). A random number generation software program (such as R or SPSS) will be used to allocate participants to either the intervention or control group. The randomization process will be conducted by an independent statistician who is not involved in the intervention or assessment procedures. Random Allocation: In this study, participants will first be selected through convenience sampling based on the inclusion criteria. After the initial assessments, they will be randomly assigned, using a Randomized Block Design, to either the intervention group or the control group (receiving routine occupational therapy interventions). The sealed envelope method will be used to conceal random allocation. Randomization will be carried out by an individual other than the therapist and assessor. Participants in both groups will be reassessed after completion of the interventions (at the end of the third month), Blinding description: This study uses a single-blind design, meaning that outcome assessors will be unaware of participants’ group allocation. To maintain blinding: * Independent assessors who are not involved in the intervention process will collect outcome data. * Parents and therapists are aware of the assigned group (due to the nature of the intervention, double blinding is not possible for them) but are prohibited from discussing group allocation with the assessors. * Raw data will be analyzed by an independent analyst who is blinded to group allocation. N/A Autism Spectrum Disorder. Intervention 1: Intervention group: 1) Conventional Occupational Therapy:This intervention will be provided to both groups with the same number and duration of sessions. Assessments will be conducted at two time points: before the intervention and immediately after completion of the intervention at the end of the third month. 2) DIR/Floortime: Parents will receive training in the Floortime-based intervention approach. This intervention includes teaching play-based interaction techniques, strengthening emotional connection, and responding to the child’s developmental needs. The training program will include the following components: Individual practical sessions: Twenty-four 60-minute sessions, conducted three times per week, with the participation of the parents, child, and therapist to practice techniques in a real-life environment. Home practice: Floortime activities at home will be designed to facilitate the generalization of skills to the natural context and environment of daily life. According to general Floortime recommendations, the home practice dosage may increase to higher levels, up to several hours per day. However, in the present study, in order to enhance feasibility and treatment adherence under real family conditions, a minimum acceptable dose and a target dose will be defined. The minimum dose will consist of at least two daily sessions of 15–20 minutes each, while the target dose will consist of four daily sessions of 15–20 minutes each. In addition, parents may provide more practice time if feasible according to family capacity. The actual implementation time, including the number of sessions and total minutes per day, will be recorded daily, and treatment adherence will be reported as a procedural variable. Intervention 2: Control group: These interventions combine bottom-up and top-down features to improve the child's social skills. Bottom-up refers to sensory-motor strategies that are used in occupational therapy clinics. Top-down refers to features of behavioral and occupational analysis. This group does not receive any specific floortime training, but the number of hours of service received is recorded so that it can be compared with the intervention group. This treatment is provided to both groups with the same number of sessions. Assessments are conducted at two time points before the intervention and at the end of the third month after the intervention. Yes - There is a plan to make this available What will be shared: Participants’ data will be presented as non-identifiable demographic data. When: The access period will begin 6 months after publication of the results and will continue for 1 year. To whom: Researchers and scientific institutions may access the data upon request from the author. Conditions: For research purposes and with the approval of the corresponding author of the article. Where to obtain: Corresponding author How to obtain: 1. Identification of the institution or researcher 2. Approval of the corresponding author Comments:
public Babak Kashefi Mehr
Department of Occupational Therapy, Faculty of Rehabilitation Sciences, next to Vahdat Hall, University of Tabriz, 29 Bahman Boulevard
Tabriz Iran (Islamic Republic of) 5166614766 +98 914 400 0469 babakkashefi@yahoo.com Tabriz University of Medical Sciences scientific Babak Kashefi Mehr
Department of Occupational Therapy, Faculty of Rehabilitation Sciences, next to Vahdat Hall, University of Tabriz, 29 Bahman Boulevard
Tabriz Iran (Islamic Republic of) 5166614766 +98 914 400 0469 babakkashefi@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Child: having a definitive diagnosis of Autism Spectrum Disorder (ASD), Level 1 or 2, according to DSM-5, made by a child psychiatrist. Child: having no acute physical problems such as visual, balance and gait, hearing problems, epilepsy, etc. Child: age: 3-5 years. Mother: having the ability to read and write. Mother: having no diagnosed chronic psychiatric or physical disorders. Mother: having no diagnosis of chronic psychiatric disorders, including depression, anxiety, or other mood and mental disorders, as well as no musculoskeletal diseases. sibling: age: 7–12 years sibling: No diagnosis of Autism Spectrum Disorder or other neurodevelopmental disorders sibling: Absence of behavioral disorders such as aggression and psychotic disorders, and no definite psychiatric diagnosis based on DSM-5 sibling: Based on parental report or the therapist’s initial observation, the sibling should be able to follow simple instructions and maintain play interactions for at least 15 minutes. The sibling should also have sufficient physical and sensory-motor abilities to participate in floor-based play activities (without motor limitations, visual impairments, hearing problems, etc.). 3 years 5 years Both Attendance in at least 75% of the intervention sessions (18 out of 24 sessions); a maximum absence of 6 sessions is acceptable without withdrawal from the study. Initiation of a new treatment during the study. Rehabilitation Rehabilitation Intervention group: 1) Conventional Occupational Therapy:This intervention will be provided to both groups with the same number and duration of sessions. Assessments will be conducted at two time points: before the intervention and immediately after completion of the intervention at the end of the third month. 2) DIR/Floortime: Parents will receive training in the Floortime-based intervention approach. This intervention includes teaching play-based interaction techniques, strengthening emotional connection, and responding to the child’s developmental needs. The training program will include the following components: Individual practical sessions: Twenty-four 60-minute sessions, conducted three times per week, with the participation of the parents, child, and therapist to practice techniques in a real-life environment. Home practice: Floortime activities at home will be designed to facilitate the generalization of skills to the natural context and environment of daily life. According to general Floortime recommendations, the home practice dosage may increase to higher levels, up to several hours per day. However, in the present study, in order to enhance feasibility and treatment adherence under real family conditions, a minimum acceptable dose and a target dose will be defined. The minimum dose will consist of at least two daily sessions of 15–20 minutes each, while the target dose will consist of four daily sessions of 15–20 minutes each. In addition, parents may provide more practice time if feasible according to family capacity. The actual implementation time, including the number of sessions and total minutes per day, will be recorded daily, and treatment adherence will be reported as a procedural variable. Control group: These interventions combine bottom-up and top-down features to improve the child's social skills. Bottom-up refers to sensory-motor strategies that are used in occupational therapy clinics. Top-down refers to features of behavioral and occupational analysis. This group does not receive any specific floortime training, but the number of hours of service received is recorded so that it can be compared with the intervention group. This treatment is provided to both groups with the same number of sessions. Assessments are conducted at two time points before the intervention and at the end of the third month after the intervention. Parents’ quality of life as measured by the WHOQOL-BREF questionnaire. Timepoint: Before the intervention (T0), and after completion of the interventions at the end of the third month (T1). Method of measurement: WHO-QOL-BREF questionnaire. Quality of sibling interactions. Timepoint: Before the intervention (T0), and after completion of the interventions at the end of the third month (T1). Method of measurement: Sibling Relationship Questionnaire. Autism symptoms in the child. Timepoint: Before the intervention (T0). Method of measurement: Gilliam Autism Rating Scale, third Edition. Social Responsiveness Scale. Timepoint: Before the intervention (T0),and after completion of the interventions at the end of the third month (T1). Method of measurement: Social Responsiveness Scale, Second Edition. Tabriz University of Medical Sciences Approved 2026-05-19 Ethics committee of Tabriz University of Medical Sciences Department of Occupational Therapy, Faculty of Rehabilitation Sciences, University of Tabriz, beside Vahdat Hall, 29 Bahman Boulevard Tabriz East Azarbaijan Iran (Islamic Republic of)