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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06126939
Other study ID # lichaofeng
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 2024
Est. completion date November 2025

Study information

Verified date February 2024
Source Hunan Normal University
Contact chaofeng li
Phone 15674960672
Email 1270136903@qq.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this clinical trial is to test the effects of parent training based on Denver model on parents' disease cognition level, coping style, parenting guilt, depression, anxiety and stress, quality of life, etc . The main question[s] it aims to answer are: - What is the status quo of autistic parents' disease cognition level, coping style, parenting guilt, depression, anxiety and stress, and quality of life - Whether education and training based on Denver model can improve autism parents' disease cognition level, coping style, parenting guilt, depression, anxiety and stress, and quality of life Participants will receive educational training based on the Denver model. The researchers will compare the Denver model of early intervention with parents who receive regular autism health guidance to explore the effect of early intervention Denver model


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 70
Est. completion date November 2025
Est. primary completion date November 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria: - The child meets the diagnostic criteria for autism in the fifth edition of the American Diagnostic and Statistical Manual of Mental Disorders, and has been diagnosed by a physician; - Parents of children aged 12-60 months with autism; - Be the father or mother of the child, live with the child and take the main care of the child; - Father =22 years old, mother =20 years old; - Clear mind, normal intelligence, with normal cognitive ability. Exclusion Criteria: - Suffering from serious heart, liver and kidney diseases and mental illness; - There are other family members suffering from serious illness or mental illness.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Educational training based on the Denver model
In addition to routine health guidance, one-to-one parent classes were conducted to guide parents to interact with children once a week for 1h each time; A group leader was assigned to supervise the formulation of the intervention plan and ensure the quality of the intervention. The intervention lasted for 3 months

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hunan Normal University

Outcome

Type Measure Description Time frame Safety issue
Primary Trait Coping Style Questionnaire The questionnaire consists of 2 dimensions (positive coping and negative coping), with 10 entries in each dimension, using a 5-level rating (1 being definitely no, 5 being definitely yes). The higher the positive coping score, the more positive, and the higher the negative coping score, the more negative. One week before the intervention and one week after the intervention
Primary Illness Cognition Questionnaire-Parent version The scale includes three dimensions: helplessness, acceptance and perceived benefit, among which acceptance and perceived benefit belong to positive cognition, while helplessness belongs to negative cognition. Likert 1 to 4 scoring method was adopted for each item, and the 3 dimensions were scored respectively. The score range of each dimension was 6 to 24 points. The higher the score, the stronger the condition of the corresponding dimension, and the score of each dimension was not cumulative One week before the intervention and one week after the intervention
Primary Depression Anxiety Stress Scales There are 21 entries in total, 7 entries each for depression, anxiety and stress subscales. This scale is a 4-point Likert self-scoring scale, and the score of each question is between 0 and 3 points, "0" means "never", "1" means "sometimes", "2" means "often", and "3" means "always". The total score of each subscale multiplied by 2 is the final score. The higher the score, the more intense the negative emotional experience. One week before the intervention and one week after the intervention
Primary Guilt about Parenting Scale The scale is a single dimension scale with 10 items. All of them adopted the 7-point scoring method, and were assigned 1-7 points from completely non-conforming to completely conforming. The total score is 10 to 70, the higher the score, the higher the level of parenting guilt of the subject One week before the intervention and one week after the intervention
Primary Beach Center Family Quality of Life Scale The scale included 25 items in 5 dimensions, including family interaction (6 items), parenting (6 items), emotional health (4 items), physical/material welfare (5 items) and support related to disability (4 items). Likert5-level scores were used, from "very dissatisfied" to "very satisfied", 1-5 points were assigned, with a total score of 25 to 125 points. The higher the score, the more satisfied the individual was with the quality of family life. One week before the intervention and one week after the intervention
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