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A prospective randomized controlled study on the effectiveness and feasibility of pre-emptive intervention in ASD high-risk population based on MACI evaluation framework

A prospective randomized controlled study on the effectiveness and feasibility of pre-emptive intervention in ASD high-risk population based on MACI evaluation framework

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500098754
Enrollment
Unknown
Registered
2025-03-13
Start date
2025-04-01
Completion date
Unknown
Last updated
2025-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism spectrum disorder

Interventions

Control group:Lecture on popular science in early childhood education
Test group:pre-emptive intervention model based on MACI framework

Sponsors

The Third Affiliated Hospital Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Infants and toddlers aged 9 months with older ASD siblings (probands); 2. Neither the child nor his or her elderly siblings have any clear neurological disease or hereditary metabolic disease or severe sensorimotor disorder; 3. The child's parents or primary caregivers have no mental health disorders; 4. Parents or main caregivers of children, care time > = 2 hours/day; 5. The child's parents or primary caregivers have simple literacy skills and can fill out the assessment questionnaire according to the real situation.

Exclusion criteria

Exclusion criteria: 1.Low birth weight infants (birth weight < 2.5 kg); 2.Premature infants (gestational age < 37 weeks); 3.Definitely diagnosed with neurological or hereditary diseases or severe sensorimotor disorders.

Design outcomes

Primary

MeasureTime frame
The improvement degree of MACI evaluation score;The development track of symptoms evaluated by MACI;

Secondary

MeasureTime frame
The improvement degree of children's development ability;Differences in diagnostic outcomes between groups;Differences between groups of core symptoms of autism;Caregiver's nurturing ability;Completion rate of caregiver course training;Caregiver satisfaction;Implementation quality of family intervention;

Countries

China

Contacts

Public ContactYou Cong

The Third Affiliated Hospital Sun Yat-sen University

youcong3@mail.sysu.edu.cn+86 20 82179607

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026