- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06920615
Stereotypic Behaviors and Feeding Difficulties in Adults With Developmental Disabilities
Stereotypi in Motor-, Vocal- and Feeding Behaviors: Novel Extensions to Adults
Study Overview
Status
Conditions
Detailed Description
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
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sigmund Eldevik, PhD, BCBA-D
- Phone Number: +47 91822707
- Email: seldevik@oslomet.no
Study Contact Backup
- Name: Petur I Petursson, MS, BCBA
- Phone Number: +47 94169375
- Email: pepetu@ous-hf.no
Study Locations
-
-
-
Oslo, Norway, 0424
- Recruiting
- Department of Neurohabilitation, Oslo University Hospital
-
Contact:
- Petur I Petursson, MS, BCBA
- Phone Number: +47 94169375
- Email: pepetu@ous-hf.no
-
Contact:
- Lotta Tholander, MA
- Phone Number: +47 22119144
- Email: lottho@ous-hf.no
-
Contact:
- Petur I Petursson, MS, BCBA
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
- the exclusion criteria do not exclude health care from The Oslo University Hospital.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intake refusal
Intervention
|
Intervention Treatment will involve backward chaining, fading and differential reinforcement.
|
|
Experimental: Slow pace of self-feeding
Intervention
|
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.
|
|
Experimental: Debilitating stereotypi
Intervention
|
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.
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Frequency recording
Time Frame: Each experimental phase will last until there is a stable-state performance of the target behavior, typically within 4-8 weeks.
|
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.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Petur I Petursson, MS, BCBA, Oslo University Hospital
- Study Chair: Sigmund Eldevik, PhD, BCBA-D, Oslo Metropolitan University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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
- 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.
- Kitfield EB, Masalsky CJ. Negative reinforcement-based treatment to increase food intake. Behav Modif. 2000 Sep;24(4):600-8. doi: 10.1177/0145445500244007.
- 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
- Kazdin (2021). Single-case research designs: Methods for clinical and applied settings. Oxford University Press.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 830334
- 25/05900 (Other Identifier: Oslo University Hospital)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
Clinical Trials on Feeding Difficulties
-
Boston Children's HospitalNot yet recruitingThe Use of High Bile-binding Foods to Reduce Upper Gastrointestinal Bile Acid Concentrations (Aim 2)Gastrostomy | Aspiration | Feeding Difficulties
-
Boston Children's HospitalRecruitingThe Use of High Bile-binding Foods to Reduce Upper Gastrointestinal Bile Acid Concentrations (Aim 1)Gastrostomy | Aspiration | Feeding DifficultiesUnited States
-
Boston Children's HospitalNot yet recruitingThe Use of High Bile-Binding Foods to Reduce Upper Gastrointestinal Bile Acid Concentrations (Aim 3)Gastrostomy | Aspiration | Feeding Difficulties
-
Hôpital de la Croix-RousseCentre National de la Recherche Scientifique, FranceCompletedInfant, Very Premature Feeding Difficulties, Neonatal Sucking BehaviorFrance
-
Kahramanmaras Sutcu Imam UniversityRecruitingBreastfeeding Difficulties | Maternal Breastfeeding Motivation | Nipple Refusal | Mother-infant BondingTurkey (Türkiye)
-
Children's Mercy Hospital Kansas CityThe Gerber Foundation; Daisy FoundationEnrolling by invitationPediatric Feeding Disorders | Feeding Difficulties | Remote Patient MonitoringUnited States
-
Benny Kerzner, MDAbbott NutritionWithdrawnFeeding and Eating Disorders of Childhood | Feeding DifficultiesUnited States
-
Ankara Medipol UniversityActive, not recruitingLong-Term Effect of Online Occupational Therapy-Based Parent Training on Feeding Problems in InfantsFood Neophobia | Feeding Problems | Feeding DifficultiesTurkey (Türkiye)
-
Necmettin Erbakan UniversityCompletedChewing Difficulties in Children | Feeding Behavior Challenges | Oral-motor Dysfunction | Impaired Chewing FunctionTurkey (Türkiye)
-
Children's Hospital Medical Center, CincinnatiCompletedDescribe the Infant Feeding Attitudes | Intentions of a Sample of Expectant First-time Mothers | Estimate the Prevalence of Early Lactation Difficulties
Clinical Trials on Fading and chaining combined with differential reinforcement
-
Oakland UniversityAuburn UniversityRecruitingProblem BehaviorUnited States
-
National Development and Research Institutes, Inc.National Institute on Drug Abuse (NIDA)CompletedCigarette SmokingUnited States
-
University of Texas at AustinUnknown
-
GCS Ramsay Santé pour l'Enseignement et la RechercheEuraxi PharmaCompleted
-
GENGERecruiting
-
Sohag UniversityNot yet recruitingFamilial Mediterranean FeverEgypt
-
Lei LiuRecruitingHead and Neck Squamous Cell CarcinomaChina
-
Sun Yat-sen UniversityWest China Hospital; Chongqing Medical University; Shanghai General Hospital,... and other collaboratorsActive, not recruitingGlaucoma, Angle-ClosureChina
-
Fudan UniversityRecruitingBrain Metastases | Triple-Negative Breast Cancer (TNBC)China
-
Hospital Universitari Joan XXIII de Tarragona.Unknown