NCT06920615

Brief Summary

Adults with developmental disabilities (DD) and autism represent a vulnerable demographic that transitions into adulthood with diverse etiologies, exhibiting a significantly higher prevalence of various challenging behaviors. These problematic behaviors can lead to adverse health outcomes and a diminished quality of life. Addressing these issues often necessitates an interdisciplinary approach to continuity of care, focusing on enhancing functional skills, empowerment, and independence, as well as preventing and mitigating challenging behaviors. The current research proposal comprises of three studies designed to evaluate the efficacy of behavioral interventions for problematic behaviors in adults with DD and autism. If left unaddressed, these behaviors may worsen over time, potentially hindering community involvement, educational opportunities, and employment prospects. These include harmful stereotypies and feeding difficulties.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
53mo left

Started Apr 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress20%
Apr 2025Aug 2030

First Submitted

Initial submission to the registry

April 8, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

April 8, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 10, 2025

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 26, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 26, 2030

Last Updated

April 15, 2025

Status Verified

April 1, 2025

Enrollment Period

5.4 years

First QC Date

April 8, 2025

Last Update Submit

April 10, 2025

Conditions

Keywords

Feeding difficulties, stereotypic behavior, challenging behavior, autism, developmental disabilities

Outcome Measures

Primary Outcomes (1)

  • Frequency recording

    Each target behavior in the study will be measured with a frequency recording and graphed as behavior change over time.

    Each experimental phase will last until there is a stable-state performance of the target behavior, typically within 4-8 weeks.

Study Arms (3)

Intake refusal

EXPERIMENTAL

Intervention

Behavioral: Fading and chaining combined with differential reinforcement

Slow pace of self-feeding

EXPERIMENTAL

Intervention

Behavioral: Differential reinforcement of high rate

Debilitating stereotypi

EXPERIMENTAL

Intervention

Behavioral: Response interruption with redirectionBehavioral: Chained schedules

Interventions

Intervention Treatment will involve backward chaining, fading and differential reinforcement.

Intake refusal

This will be identical to baseline, except a DRH will be introduced: The participant will be instructed to complete his whole meal within set time criteria to receive an identified reinforcer.

Slow pace of self-feeding

RIRD involves physically blocking a movement from occurring using the least amount of physical contact for max 3 s, and then redirecting behavior to an ongoing activity or movement. Stereotypi that is verbal or not possible to block physically will involve a demand to answer a verbal question or a motor task that sufficiently interrupts the behavior and then redirecting.

Debilitating stereotypi

The following procedures are based on Slaton et al. (2016): At the start of each session, the candidate or therapist will hold up the red card, prompt the participant to touch the card, while saying "we are in red now, time to work". The participant will have to perform age- or function appropriate tasks without stereotypi to gain access to the green phase. Demand will be designated with a token economy, where each token represents completion of a certain amount of task-related responses. The participant will not be prompted to perform the tasks. If the participant makes an error in a task (e.g. answer a math question incorrectly), this will lead to an error correction and no token will be presented. If stereotypi occurs, it will be blocked for up to 3 s, and then all demands will be reset by removing all earned tokens.

Also known as: Differential reinforcement utilizing access to stereotypi
Debilitating stereotypi

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants will be recruited through referrals at the Department of Neurohabilitation, or from other hospitals in the Oslo Region.
  • be 18 years or older,
  • have a DD, autism spectrum disorder or a PDD-NOS diagnosis
  • and be referred to the specialist habilitation service for adults.

You may not qualify if:

  • If there are medical causes of the participant's behavioral problem or
  • a reasonable possibility that the referred problem is caused by medical variables
  • if the client participant receives communal care services and if those are not in accordance with Norwegian standards of services for individuals with DD.
  • This could include inappropriate staff-to-client ratio,
  • lack of stimulating activities,
  • or if on-site training is insufficient.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurohabilitation, Oslo University Hospital

Oslo, Oslo County, 0424, Norway

RECRUITING

Related Publications (14)

  • Williams, E.W., Seiverling, L.J., & Field, D.G. (2014). Feeding problems. In: P. Sturmey & R. Didden (Eds.), Evidence-Based Practice and Intellectual Disabilities (pp. 198-213). Wiley Blackwell.

    BACKGROUND
  • Volkert, V.M., Patel, M.R., Peterson, K.M. (2016). Food refusal and selective eating. In: Luiselli, J. (ed) Behavioral Health Promotion and Intervention in Intellectual and Developmental Disabilities. Evidence-Based Practices in Behavioral Health. Springer, Cham. https://doi.org/10.1007/978-3-319-27297-9_7

    BACKGROUND
  • Ratnasuriya RH, Marks IM, Forshaw DM, Hymas NF. Obsessive slowness revisited. Br J Psychiatry. 1991 Aug;159:273-4. doi: 10.1192/bjp.159.2.273.

    PMID: 1773246BACKGROUND
  • Kitfield EB, Masalsky CJ. Negative reinforcement-based treatment to increase food intake. Behav Modif. 2000 Sep;24(4):600-8. doi: 10.1177/0145445500244007.

    PMID: 10992614BACKGROUND
  • Association of Professional Behavior Analysts. (2009). The use of restraint and seclusion as interventions for dangerous and destructive behaviors. www.apbahome.net/Restraint_Seclusion%20.pdf

    BACKGROUND
  • Kazdin (2021). Single-case research designs: Methods for clinical and applied settings. Oxford University Press.

    BACKGROUND
  • Jarness, M., Petursson, P.I. & Eldevik, S. (2019). Trening av verbale operanter og differensiell forsterkning fører til økning i passende vokalisering og reduksjon i upassende vokalisering: Et kasus studie basert på en funksjonell analyse. Norsk Tidsskrift for Atferdsanalyse, 46, 71-83.

    BACKGROUND
  • Iwata BA, Dorsey MF, Slifer KJ, Bauman KE, Richman GS. Toward a functional analysis of self-injury. J Appl Behav Anal. 1994 Summer;27(2):197-209. doi: 10.1901/jaba.1994.27-197.

    PMID: 8063622BACKGROUND
  • Hagopian LP, Kurtz PF, Bowman LG, O'Connor JT, Cataldo MF. A Neurobehavioral Continuum of Care for Individuals with Intellectual and Developmental Disabilities with Severe Problem Behavior. Child Health Care. 2023;52(1):45-69. doi: 10.1080/02739615.2021.1987237. Epub 2022 Jan 25.

    PMID: 36643575BACKGROUND
  • Hagopian LP, Farrell DA, Amari A. Treating total liquid refusal with backward chaining and fading. J Appl Behav Anal. 1996 Winter;29(4):573-5. doi: 10.1901/jaba.1996.29-573.

    PMID: 8995838BACKGROUND
  • Grinblat N, Rosenblum S. Why are they late? Timing abilities and executive control among students with learning disabilities. Res Dev Disabil. 2016 Dec;59:105-114. doi: 10.1016/j.ridd.2016.07.012. Epub 2016 Aug 12.

    PMID: 27525557BACKGROUND
  • Fjellstedt N, Sulzer-Azaroff B. Reducing latency of a child's responding to instructions by means of a token system. J Appl Behav Anal. 1973 Spring;6(1):125-30. doi: 10.1901/jaba.1973.6-125.

    PMID: 16795384BACKGROUND
  • Fisher W, Piazza CC, Bowman LG, Hagopian LP, Owens JC, Slevin I. A comparison of two approaches for identifying reinforcers for persons with severe and profound disabilities. J Appl Behav Anal. 1992 Summer;25(2):491-8. doi: 10.1901/jaba.1992.25-491.

    PMID: 1634435BACKGROUND
  • Borrero, C. S., Schlereth, G. J., Rubio, E. K., & Taylor, T. (2013). A comparison of two physical guidance procedures in the treatment of pediatric food refusal. Behavioral Interventions, 28, 261-280. https://doi.org/10.1002/bin.1373

    BACKGROUND

MeSH Terms

Conditions

Stereotypic Movement DisorderAutistic DisorderDevelopmental Disabilities

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental DisordersAutism Spectrum DisorderChild Development Disorders, Pervasive

Study Officials

  • Petur I Petursson, MS, BCBA

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR
  • Sigmund Eldevik, PhD, BCBA-D

    Oslo Metropolitan University

    STUDY CHAIR

Central Study Contacts

Sigmund Eldevik, PhD, BCBA-D

CONTACT

Petur I Petursson, MS, BCBA

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: The research utilizes single-case experimental designs for each individual participant
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

April 8, 2025

First Posted

April 10, 2025

Study Start

April 8, 2025

Primary Completion (Estimated)

August 26, 2030

Study Completion (Estimated)

August 26, 2030

Last Updated

April 15, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations