Stereotypic Behaviors and Feeding Difficulties in Adults With Developmental Disabilities

NCT ID: NCT06920615

Last Updated: 2025-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-08

Study Completion Date

2030-08-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Study 1: A behavioral intervention of food refusal in adults with developmental disabilities

Feeding disorders are common in both children and adults with DD. Among the most serious of these is the total refusal to consume food and liquid, which may present a life-threatening or severely debilitating condition. The evidence base for interventions for adults with DD and food refusal is severely limited or lacking to my knowledge. One notable exception is a study by Kitfield and Masalsky (2000), who treated a woman aged 22 using a behavioral intervention consisting of negative reinforcement in the form of escape from food as well as to other areas, which resulted in impressive weight gains during treatment and follow-up. The lack of empirically supported treatment for food refusal in adults with DD may be because food-related issues usually have an early onset and are, therefore, more often diagnosed and treated in children. Additionally, some treatments may be viewed as more invasive when applied to adults. For example, escape extinction is the most empirically supported treatment component for food refusal and selective eating among children with DD. However, implementing escape extinction in an adult may be ethically questionable because of its invasive nature, which is practically challenging or dangerous, especially when other problem behaviors are present.

In a study by Hagopian et al. (1996), total food and liquid refusal in a 12-year old boy with autism was treated with backward chaining, fading, and activity reinforcement, which successfully resulted in drinking from a cup generalized to his living unit. Fading and differential reinforcement may have an ethical and intuitive appeal when treating food and liquid refusal in adults with DD and may therefore be accepted by caregivers and adults with DD. This is because it involves gradual re-introduction of oral intake and the use of positive reinforcement. In addition, research has demonstrated that stimulus fading may render escape extinction unnecessary. Therefore, there is a need to extend the use of such procedures to adults with food and/or liquid refusal.

Study 2: A behavioral intervention of slow eating in adults with DD

Individuals with DD often require considerably more time to complete tasks of daily living than their neurotypical peers do. When slow responding becomes excessive, it may be a barrier in daily living as self-care, and finishing meals in time before scheduled events may lead to missed activities or services, family stress, and logistical challenges. Such slowness has been hypothesized to result from neurological impairments causing a slow motor response, a secondary symptom of obsessive compulsive disorder, or as a primary feature, an operant modifiable by its consequences.

Slow responding has been the subject of three empirical investigations in the behavioral literature, with two children and one adult. In all cases, the researchers utilized positive reinforcement to accelerate slow responses. Fjellstedt and Sulzer-Azároff (1973) used a differential reinforcement of low response latencies (DRL) for the following five different types of instructions to perform tasks, resulting in a substantial improvement in the speed of response. Tiger et al. (2007) increased the slow response of an adult male with Asperger's syndrome with a DRL, which resulted in a clinically significant increase in the response to two tasks. Girolami et al. (2008) utilized differential reinforcement of high rate (DRH) to increase the rate of independent bites by a child participant with ADHD and several medical issues. This procedure results in an increased rate of self-feeding. We plan to systematically replicate a DRH procedure for adults suffering from slow-feeding difficulties, with modifications involving the use of changing criteria for reinforcement.

Study 3: A behavioral treatment of debilitating stereotypy in adults, comparing response interruption with redirection and chained schedules

Stereotypy refers to behavior topographies in individuals with autism and DD that are invariable, repeating, meaningless, or out of context. These topographies can present a considerable amount of distress for the individuals and their family members as it may be a barrier for habilitation, independent living and learning. Because the majority of researched stereotypi in individuals with autism have automatic reinforcement as its function, a new strategy for functional analysis (FA) of stereotypi involves pre-treatment screening for automatic reinforcement.

Function-based treatment of automatically maintained stereotypy is particularly challenging because reinforcers are not easily manipulated or extinguished. Physically preventing stereotypi in adults may be practically challenging, especially because it may elicit emotional or aggressive behavior. For example, response blocking has been documented to reduce automatically maintained pica but increase aggressive behavior. Research has shown that when stereotypi are both blocked and redirected toward an ongoing behavior, aggressive behavior does not increase. A treatment procedure for automatically maintained stereotypi, called response interruption with redirection (RIRD), involves interrupting each instance of stereotypi and redirecting behavior to an ongoing task or appropriate behavior. RIRD has received extensive empirical support from child participants for reducing stereotypi, but has not been researched in adults. Another treatment procedure that has recently received increased attention in behavioral literature is chained schedules (CS), often contrasted with multiple schedules (MS), both of which are different procedures for programming stimulus control over stereotypi. MS involves the use of discriminative stimuli (SD/S+ vs. SΔ/S-) for different treatment components, where in one phase, all instances of stereotypi are blocked in the presence of S- (e.g., at red card), while in the presence of S+ (e.g., a green card), all instances of stereotypi are allowed. However, no reinforcement contingency was programmed. On the other hand, CS also involves blocking stereotypi in the presence of S-, but providing contingent access to stereotypi from one component (red card/ S-) to the other (green card/ S+) contingent upon the absence of stereotypi. Therefore, alternation between the two components depends on the performance of one of the components. When compared to MS, most empirical demonstrations favor CS, both in terms of the reduction of stereotypi and an increase in adequate item engagement. As pointed out by Sloman et al. (2022), autism advocates view access to "stimming" as a means for individuals with autism to self-sooth and regulate emotions, and may therefore be more preferred. However, the CS procedure is more complicated than the RIRD procedure (see below). In addition, the RIRD does not program a differential reinforcement of alternative responses. CS may, therefore, be preferred by adults and caregivers in that it targets increasing adaptive responses. However, some treatment settings may favor RIRD over CS because of its ease of implementation. An interesting question is whether caregivers and clients provide different answers to these questions. Therefore, the current research question concerns a) the efficacy of RIRD as compared to CS, both in terms of behavior reduction and treatment duration, b) client vs. caretaker preference for either treatment procedure, c) extension of these two empirically supported treatments to adult participants, and d) generalization to the most problematic settings in daily life.

\[PP2\]Hope this clears it up

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Harmful Stereotypies Feeding Difficulties

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

The research utilizes single-case experimental designs for each individual participant
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intake refusal

Intervention

Group Type EXPERIMENTAL

Fading and chaining combined with differential reinforcement

Intervention Type BEHAVIORAL

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

Slow pace of self-feeding

Intervention

Group Type EXPERIMENTAL

Differential reinforcement of high rate

Intervention Type BEHAVIORAL

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.

Debilitating stereotypi

Intervention

Group Type EXPERIMENTAL

Response interruption with redirection

Intervention Type BEHAVIORAL

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.

Chained schedules

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Fading and chaining combined with differential reinforcement

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

Intervention Type BEHAVIORAL

Differential reinforcement of high rate

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.

Intervention Type BEHAVIORAL

Response interruption with redirection

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.

Intervention Type BEHAVIORAL

Chained schedules

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.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Differential reinforcement utilizing access to stereotypi

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Oslo Metropolitan University

OTHER

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Petur Ingi Petursson

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Petur I Petursson, MS, BCBA

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Sigmund Eldevik, PhD, BCBA-D

Role: STUDY_CHAIR

Oslo Metropolitan University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Neurohabilitation, Oslo University Hospital

Oslo, Oslo County, Norway

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Norway

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Sigmund Eldevik, PhD, BCBA-D

Role: CONTACT

+47 91822707

Petur I Petursson, MS, BCBA

Role: CONTACT

+47 94169375

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Petur I Petursson, MS, BCBA

Role: primary

+47 94169375

Lotta Tholander, MA

Role: backup

+47 22119144

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type 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

Reference Type 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.

Reference Type BACKGROUND
PMID: 1773246 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 10992614 (View on PubMed)

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

Reference Type BACKGROUND

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

Reference Type 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.

Reference Type 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.

Reference Type BACKGROUND
PMID: 8063622 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36643575 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8995838 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27525557 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16795384 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1634435 (View on PubMed)

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

Reference Type BACKGROUND

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

25/05900

Identifier Type: OTHER

Identifier Source: secondary_id

830334

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

A Novel Framework for Impaired Imitation in ASD
NCT03423160 ACTIVE_NOT_RECRUITING
Shaping Tolerance for Delayed Rewards
NCT03457402 RECRUITING NA