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IRCT20250822066951N1 IRCT 2026-09-03 Mashhad University of Medical Sciences Effectiveness of Equine-Assisted Intervention on Psychological and Physiological Outcomes in Mothers of Children with Autism Spectrum Disorder EAI-ASD Effectiveness of Equine-Assisted Intervention on Psychological and Physiological Outcomes in Mothers of Children with Autism Spectrum Disorder 2026-06-24 anticipated 76 Complete https://irct.ir/trial/93000 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: This study is a randomized controlled trial with two parallel groups: an intervention group and a wait-list control group. Following baseline assessment, participants will be randomly allocated in a 1:1 ratio to the two groups. The intervention group will receive a structured equine-assisted intervention consisting of 12 sessions over 6 weeks, while the control group will remain on the wait-list during the study period. Outcome assessments will be conducted at two time points: before the intervention (baseline) and immediately after completion of the intervention, Randomization description: After confirming eligibility and obtaining written informed consent, participants will be randomly allocated in a 1:1 ratio to either the intervention group or the wait-list control group. The random allocation sequence will be generated using a random number table. To ensure allocation concealment, the group assignments will be placed in sequentially numbered, opaque, sealed envelopes. After completion of the baseline assessment, the envelope corresponding to each participant will be opened in numerical order, and the assigned group will be revealed. N/A autism spectrum disorder. Control group: Mothers will be placed on a wait list and will not receive the equine assisted intervention during the study period. Assessments will be performed at baseline and immediately after the intervention period. After completion of the post test assessment, the intervention will be provided to this group according to the study protocol.Intervention group: Mothers will receive 12 structured equine assisted intervention sessions over 6 weeks, two sessions per week, with each session lasting 45 minutes. The intervention includes safety preparation and instruction, structured interaction with the horse, grooming and care of the horse, movement and balance exercises, basic riding, horse guiding, and structured activities targeting emotional regulation, self efficacy, resilience, and reduction of parenting stress. Sessions will be conducted by a qualified instructor with trained horses at the equestrian facility of Ferdowsi University of Mashhad.. No - There is not a plan to make this available Justification or reason for not sharing IPD is Due to confidentiality and privacy considerations, as well as the sensitive nature of the psychological and physiological data, there is no plan to share individual participant data.
public zahra Mansourjozan
Azadi Street, Alley 63, No. 15, 2nd Floor
Mashhad Iran (Islamic Republic of) 91997944688 +98 915 156 3578 zahra_mansuri65@yahoo.com Ferdowsi University of Mashhad Equestrian Club scientific Zahra Mansourjozan
Azadi Street, Alley 63, No. 15, 2nd Floor
mashhad Iran (Islamic Republic of) 91997944688 +98 915 156 3578 zahra_mansuri65@yahoo.com Ferdowsi University of Mashhad Equestrian Club Iran (Islamic Republic of) * Biological mother of a child with autism spectrum disorder (ASD)* Child's ASD diagnosis confirmed according to DSM-5 by a child and adolescent psychiatrist* Child aged 6–12 years* Living in Mashhad and able to attend the intervention sessions regularly* Ability to read and write in Persian* No regular equine-assisted intervention or hippotherapy during the previous 6 months* Written informed consent to participate in the study* Relative stability of medication status during the previous 4 weeks, if applicable 25 years 55 years Female * Withdrawal of willingness to participate in the study* Presence of an acute medical condition or psychiatric disorder that makes participation in the intervention unsafe* Major physical limitation that prevents safe participation in equine-assisted activities* Occurrence of a serious adverse event or accident that makes continued participation inappropriate Treatment - Other Control group: Mothers will be placed on a wait list and will not receive the equine assisted intervention during the study period. Assessments will be performed at baseline and immediately after the intervention period. After completion of the post test assessment, the intervention will be provided to this group according to the study protocol.Intervention group: Mothers will receive 12 structured equine assisted intervention sessions over 6 weeks, two sessions per week, with each session lasting 45 minutes. The intervention includes safety preparation and instruction, structured interaction with the horse, grooming and care of the horse, movement and balance exercises, basic riding, horse guiding, and structured activities targeting emotional regulation, self efficacy, resilience, and reduction of parenting stress. Sessions will be conducted by a qualified instructor with trained horses at the equestrian facility of Ferdowsi University of Mashhad. Parenting stress score measured using the Parenting Stress Index, Short Form (PSI-SF), assessed at baseline and immediately after completion of the intervention. Timepoint: The primary outcome will be measured at baseline, before the intervention, and immediately after completion of the 12 intervention sessions in week 6. Method of measurement: Parenting stress will be measured using the Parenting Stress Index, Short Form (PSI-SF). Mothers will complete the questionnaire under standardized conditions at baseline and immediately after completion of the intervention. The total parenting stress score will be recorded as the primary outcome. Secondary outcomes include psychological well being, resilience, life satisfaction, depression, anxiety and stress, resting heart rate, and heart rate variability. Psychological outcomes will be assessed using the Ryff Psychological Well Being Scale, 18 item version, the Connor Davidson Resilience Scale, 10 item version, the Satisfaction With Life Scale, and the Depression Anxiety Stress Scale, 21 item version. Physiological outcomes will include resting heart rate and heart rate variability indices, including RMSSD, LF/HF, and SampEn. Timepoint: Secondary outcomes will be measured at baseline, before the intervention, and immediately after completion of the 12 intervention sessions in week 6. Method of measurement: Psychological well being will be measured using the Ryff Psychological Well Being Scale, 18 item version; resilience using the Connor Davidson Resilience Scale, 10 item version; life satisfaction using the Satisfaction With Life Scale; and depression, anxiety and stress using the Depression Anxiety Stress Scale, 21 item version. Resting heart rate and heart rate variability will be measured using a 5 minute seated resting recording. Heart rate variability indices will include RMSSD, LF/HF, and SampEn. Ferdowsi University of Mashhad Equestrian Club and Self Funding by the Researchers Approved 2026-06-24 Ethics Committee of Mashhad University of Medical Sciences Azadi Street, No. 15, 2nd Floor, Alley 63 Mashhad Razavi Khorasan Iran (Islamic Republic of)