Structured Function-Based Elopement Treatment Program

NCT03899831 | Completed

• 1 other identifier: IRB00108995
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to extend the researchers' prior work on Function-Based Elopement Treatment (FBET) with a randomized controlled trial to evaluate the efficacy of FBET in 76 children with autism spectrum disorder (ASD) and elopement. Participants will be randomized to FBET or an active control group receiving a parent education program (PEP). Each study arm will include 12 appointments over 16 weeks and will be administered by a Board Certified Behavior Analyst (BCBA).

Conditions

Autism Spectrum Disorder

Keywords

Elopement

Outcome Measures

Primary Outcomes (1)

• Change in Aberrant Behavior Checklist - Hyperactivity (ABC-H) Subscale Score

  Elopement will be measured by the hyperactivity subscale of the Aberrant Behavior Checklist (ABC-H). The full ABC is a 58-item caregiver completed measure with 5 subscales. It is used extensively with children with ASD in clinical trials and has demonstrated validity and reliability with this population. Although the ABC-H targets hyperactivity, there are several items directly related to elopement. The hyperactivity subscale includes 16 items that are answered on a scale of 0 (not a problem) to 3 (severe problem). Scores for this subscale range from 0 to 48, where higher scores indicate a higher severity of hyperactivity.

  Baseline, Week 16

Secondary Outcomes (6)

• Change in Clinical Global Impression - Improvement (CGI-I) Score

  Week 16

• Change in Home Elopement Safety Checklist (HESC) Score

  Baseline, Week 16

• Direct observation of elopement frequency

  Baseline, Week 16

• Change in Aberrant Behavior Checklist - Hyperactivity (ABC-H) Subscale Score

  Week 16, Week 28

• Change in Clinical Global Impression - Improvement (CGI-I) Score

  Week 28

Other Outcomes (1)

• Change in Aberrant Behavior Checklist - Irritability (ABC-I) Scale Score

  Baseline, Week 16

Study Arms (2)

Function-Based Elopement Treatment (FBET)

EXPERIMENTAL

Participants in this group will receive Function-Based Elopement Treatment (FBET) for 16 weeks.

Behavioral: Function-Based Elopement Treatment (FBET)

Parent Education Program (PEP)

ACTIVE COMPARATOR

Participants in this group will take part in a parent education program (PEP) for 16 weeks.

Behavioral: Parent Education Program (PEP)

Interventions

Function-Based Elopement Treatment (FBET) BEHAVIORAL

The Function-Based Elopement Treatment (FBET) includes 12 appointments over 16 weeks. FBET focuses on parent-training, with the parent implementing procedures with therapist support. The goals of FBET are: * to create a safer environment * teach adaptive skills to replace elopement * arrange the environment and rewards to reduce elopement * and teach caregivers how to respond if elopement occurs Psychoeducation is emphasized, including discussions of elopement as a learned behavior, reinforcement, functions of elopement, extinction, and descriptions of treatment components. The FBET manual includes scripted text, examples, caregiver completed activities, and checks for understanding.

Function-Based Elopement Treatment (FBET)

Parent Education Program (PEP) BEHAVIORAL

The Parent Education Program (PEP) will include 12 appointments over 16 weeks, focused on general education about autism spectrum disorder and resources about elopement prevention. PEP will be administered by a Board Certified Behavior Analyst (BCBA). Participants randomized to the PEP study arm can receive the FBET intervention after completing the 16 week study period.

Parent Education Program (PEP)

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• age ≥ 4 to ≤ 12
• diagnosis of ASD, confirmed by clinical characterization of an Autism Diagnostic Observation Schedule (ADOS), Autism Diagnostic Interview-Revised (ADI-R), or Childhood Autism Rating Scale-Second Edition (CARS-2), cognitive (e.g., Differential Abilities Scale \[DAS\], Mullen Scales of Early Learning \[MSEL or Mullen\]), and adaptive assessments (Vineland Adaptive Behavior Scales-Third Edition \[Vineland-3\])
• chief complaint of elopement
• an ABC-H score \> 18

You may not qualify if:

• caregivers who report they cannot reliably attend appointments
• ongoing or planned treatment that would likely impact elopement
• challenging behavior that should be treated prior to elopement

Sponsors & Collaborators

• Emory University: lead
• Autism Speaks: collaborator

Study Sites (1)

Marcus Autism Center

Atlanta, Georgia, 30329, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Mindy Scheithauer, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome measures will be administered by a blinded independent evaluator.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants will be randomly assigned to FBET or PEP in a 1:1 ratio using random permuted blocks of size 2 and 4. After Wk 16, participants in the PEP group will be offered the FBET.

Study Record Dates

• First Submitted: April 1, 2019
• First Posted: April 2, 2019
• Study Start: May 9, 2019
• Primary Completion: April 3, 2023
• Study Completion: May 4, 2023
• Last Updated: August 8, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: IPD will be shared beginning 3 months after article publication and ending 5 years following publication.
• Access Criteria: IPD will be shared with researchers providing a methodologically sound proposal in order to achieve the aims in the proposal or for meta-analyses. Proposals should be directed to Mindy.Scheithauer@choa.org. To gain access, data requestors may need to sign a data access agreement. Proposals may be submitted up to 5 years following article publications.

Locations

US (1)