NCT05554198

Brief Summary

For parents of children with autism spectrum disorder (ASD), the severity of the child's behavior negatively correlates with parental well-being. Parental education and support buffers stress and negative effects that some parents experience. Parents living in rural areas face several barriers to obtaining support, psychoeducation, and ASD interventions due to a lack of local resources. This pilot study will test the acceptability, feasibility and preliminary effects of Attend Behavior, a Web-based behavioral parent training (PT) program, for parents of children with ASD in rural areas. The program goals are to decrease child problem behaviors and improve parental mental health. Methods: Parents (N = 40) of young children (2-11 years old) diagnosed with ASD will be recruited. A single group pre/post-intervention design using mixed methods will be used to determine the acceptability, feasibility, and preliminary efficacy. The effects of Attend Behavior on parent mental health will be measured. The effects of Attend Behavior on child problem behaviors will be measured. Individual interviews with the parents will take place post-intervention to ascertain perspectives on Attend Behavior. Acceptability and feasibility will also be measured using the Acceptability of Intervention, Intervention Appropriateness Measure, and the Feasibility of Intervention Measure. Effect sizes will be calculated to examine the efficacy of the intervention.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 26, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

January 9, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2024

Completed
Last Updated

December 19, 2024

Status Verified

December 1, 2024

Enrollment Period

1.5 years

First QC Date

September 21, 2022

Last Update Submit

December 16, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Intervention acceptability Interview

    1:1 semi-structured interview

    Post intervention (12 weeks post-baseline)

  • Intervention feasibility

    Rates of completion of intervention and recruitment/retention rates

    Post intervention (12 weeks post-baseline)

  • Acceptability of Intervention (AIM),Intervention Appropriateness Measure (IAM), Feasibility of Intervention (FIM)

    Total of 12-items answered on a Likert scale of 1 = completely disagree to 5 = completely agree, the AIM, IAM, and FIM is a brief measurement to examine implementation success

    Post intervention (12 weeks post-baseline)

Secondary Outcomes (4)

  • Aberrant Behavior Checklist (ABC)

    Baseline and Post intervention (12 weeks post-baseline)

  • Home Situations Questionnaire-Autism Spectrum Disorder (HSQ-ASD)

    Baseline and Post intervention (12 weeks post-baseline)

  • Patient-Reported Outcome Measurement Information System (PROMIS) Depression - Short Form 6a

    Baseline and Post intervention (12 weeks post-baseline)

  • Parenting Stress Index-Short Form (PSI-SF)

    Baseline and Post intervention (12 weeks post-baseline)

Study Arms (1)

Pilot Intervention

EXPERIMENTAL

pre/post-test, mixed method study design with quantitative data collection at baseline and post-intervention and qualitative data collection once at post-intervention. Participants will have access to the Attend Behavior program for a full year, but intervention usage monitoring and study outcomes will be assessed until post-intervention (12-weeks post-baseline).

Behavioral: Attend Behavior Parent Training

Interventions

Attend Behavior is a Parent Training intervention available in application form for smartphones or online. Attend Behavior consists of 12 instructional modules and it is recommended that parents complete one module a week in addition to practicing the techniques taught in that course. Each learning module typically around 30 minutes to complete and includes an introductory video to give parents an overview of the different features of the application. At the start of the intervention, parents will take an assessment that will provide information for the program to create individualized goals, plans, reinforcement agents, and even daily schedules. A HIPPA compliant clinician portal within the application allows the clinician to have real time access to monitor the parent learning progress, tracked behaviors, parental notes, and message with the parent.

Pilot Intervention

Eligibility Criteria

Age2 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • legal guardian of one or more children ages 2-11 years old with a formal diagnosis of ASD by parent report;
  • child with ASD resides at home with the parent;
  • parent age is 18 years or older;
  • reside in a rural (micropolitan or noncore) county;
  • access to either a smartphone with the Apple App store or Google Play store or a computer with Internet access;
  • ability to read English

You may not qualify if:

  • \- currently participating in another behavior Parent Training program or in the past 6-months have been enrolled in another behavior Parent Training program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ohio State University College of Nursing

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: The proposed study uses a single group, pre/post-test, mixed method study design with quantitative data collection at baseline and post-intervention and qualitative data collection once at post-intervention. Participants will have access to the Attend Behavior program for a full year, but intervention usage monitoring and study outcomes will be assessed until post-intervention (12-weeks post-baseline).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2022

First Posted

September 26, 2022

Study Start

January 9, 2023

Primary Completion

June 25, 2024

Study Completion

June 25, 2024

Last Updated

December 19, 2024

Record last verified: 2024-12

Locations