A Study on the Effect of Education Training on Parents With Autism Based on Denver Model

NCT06126939 | Not Yet Recruiting

• 1 other identifier: lichaofeng
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Autism; Parents

Keywords

denver model; training; Intervention effect

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Denver group

EXPERIMENTAL

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

Behavioral: Educational training based on the Denver model

Control group

NO INTERVENTION

Regular autism related knowledge health education

Interventions

Educational training based on the Denver model BEHAVIORAL

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

Denver group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Suffering from serious heart, liver and kidney diseases and mental illness;
• There are other family members suffering from serious illness or mental illness.

Sponsors & Collaborators

• Hunan Normal University: lead

MeSH Terms

Conditions

Autistic Disorder

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

chaofeng li

CONTACT

15674960672; 1270136903@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse practitioner

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: November 13, 2023
• Study Start: March 1, 2024
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2025
• Last Updated: March 1, 2024

Record last verified: 2024-02