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

• ClinicalTrials.gov Identifier: NCT06126939
• Recruitment Status: Not yet recruiting
• First Posted: November 13, 2023
• Last Update Posted: March 1, 2024
• Sponsor: Hunan Normal University
• Information provided by (Responsible Party): lichao feng, Hunan Normal University

Tracking Information

• First Submitted Date: November 7, 2023
• First Posted Date: November 13, 2023
• Last Update Posted Date: March 1, 2024
• Estimated Study Start Date: March 2024
• Estimated Primary Completion Date: November 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 7, 2023)

• Trait Coping Style Questionnaire [ Time Frame: One week before the intervention and one week after the intervention ]
  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.
• Illness Cognition Questionnaire-Parent version [ Time Frame: One week before the intervention and one week after the intervention ]
  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
• Depression Anxiety Stress Scales [ Time Frame: One week before the intervention and one week after the intervention ]
  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.
• Guilt about Parenting Scale [ Time Frame: One week before the intervention and one week after the intervention ]
  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
• Beach Center Family Quality of Life Scale [ Time Frame: One week before the intervention and one week after the intervention ]
  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.

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study on the Effect of Education Training on Parents With Autism Based on Denver Model
• Official Title: A Study on the Effect of Education Training on Parents With Autism Based on Denver Model

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

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Outcomes Assessor); Primary Purpose: Other

Condition

• Autism
• Parents

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

Study Arms

• Experimental: Denver group
  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
  Intervention: Behavioral: Educational training based on the Denver model
• No Intervention: Control group
  Regular autism related knowledge health education

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: November 7, 2023): 70
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: November 2025
• Estimated Primary Completion Date: November 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: chaofeng li; 15674960672; 1270136903@qq.com

• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT06126939
• Other Study ID Numbers: lichaofeng
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: lichao feng, Hunan Normal University
• Original Responsible Party: lichao feng, Hunan Normal University, Medical School of Hunan Normal University
• Current Study Sponsor: Hunan Normal University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Hunan Normal University
• Verification Date: February 2024