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

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

Study Description
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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


Condition or disease Intervention/treatment Phase
Autism Parents Behavioral: Educational training based on the Denver model Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Other
Official Title: A Study on the Effect of Education Training on Parents With Autism Based on Denver Model
Estimated Study Start Date : March 2024
Estimated Primary Completion Date : November 2024
Estimated Study Completion Date : November 2025
Arms and Interventions
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Arm Intervention/treatment
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
 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
No Intervention: Control group
Regular autism related knowledge health education


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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

  3. 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.

  4. 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

  5. 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.


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06126939


Contacts
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Contact: chaofeng li 15674960672 1270136903@qq.com

Sponsors and Collaborators
Hunan Normal University
More Information
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Responsible Party: lichao feng, Nurse practitioner, Hunan Normal University
ClinicalTrials.gov Identifier: NCT06126939    
Other Study ID Numbers: lichaofeng
First Posted: November 13, 2023    Key Record Dates
Last Update Posted: March 1, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by lichao feng, Hunan Normal University:
denver model
training
Intervention effect
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders