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

February 29, 2024 updated by: lichao feng, Hunan Normal University

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
One week before the intervention and one week after the intervention
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
One week before the intervention and one week after the intervention
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.
One week before the intervention and one week after the intervention
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
One week before the intervention and one week after the intervention
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.
One week before the intervention and one week after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hunan Normal University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

November 1, 2025

Study Registration Dates

First Submitted

November 7, 2023

First Submitted That Met QC Criteria

November 7, 2023

First Posted (Actual)

November 13, 2023

Study Record Updates

Last Update Posted (Estimated)

March 1, 2024

Last Update Submitted That Met QC Criteria

February 29, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • lichaofeng

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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