The effects of low-intensity DTT on mental and physical healthiness of ASD children

JRCT ID: jRCT1030210396

Registered date:29/10/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: ASD
• Date of first enrollment: 29/10/2021
• Target sample size: 10
• Study type: Observational

Outcome(s)

• Primary Outcome: Facial expressions were evaluated during DTT therapy; at the start of the research, and at 1 year later. Patient (or main caregiver) shoots a 20-minutes video, so that the child's facial expression can be seen well. Evaluation is done by same three research coordinators (members of the rehabilitation department). Facial expression is judged 10 times at 2-minute intervals, and the average values of 'smiley face or laughter' and'crying face or cry' are calculated. Video one year later will be re-evaluated, and the ASD children of extremery increased value of'crying face or cry' will be judged as unhealthy.

Secondary Outcome

1) normal physical examination findings of the patients.
2) parental depression and mental health (in a simple way using a questionnaire such as BDI-II and GHQ-28).
3) growth of DQ/IQ one year later (by using Kyoto Scale of Psychological Development 2001, or Wechsler Preschool and Primary Scale of Intelligence).
4) diagnosis of ASD and evaluation of ASD characteristics, by PARS-TR and SRS-2 at the time of registration.
5) subjective evaluation (thoughts, impressions) of the videos by the same three research coordinators.

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: <= 15age old
• Gender: Both

Include criteria

1) pediatric patients visiting the outpatient department of Niigata National Hospital, between August 1st, 2021 and July 31th, 2022.
2) patients who can obtain consent from the parental authority by free will.
3) ASD patients diagnosed by the criteria of DSM-5.
4) pediatric patients of age under 15 at teh time of study registration.
5) patients with no other severe physical disability.
6) patients with or without other rehabilitation methods.

• Exclude criteria: attending physician has cancers for a patient to join this clinical study and/or for a patient to be a hinder of evaluation the result.

Related Information

• Primary Sponsor: Fujinaka Hidehiko