Parent-Child RelationsNCT03071120
Parent-Mediated Intervention for Families With Children With Autism and Feeding Challenges
A study testing Parent-Mediated Intervention in people with Parent-Child Relations and Meals, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The goal is to pilot a parent-mediated intervention for feeding challenges in children with autism building on recent research and current successful models already being used. A parent-mediated intervention would primarily occur in the home environment, working with the parent to establish goals and implement the… Read more about this study
- Who is it for?
- Ages 2 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Parent-Child Relations, Meals, Autism Spectrum Disorder
- What is being tested?
- Parent-Mediated Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2017to 30 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Child with a confirmed diagnosis of ASD (ages 2-7 years)
- Parent reported feeding problems
- English Speaking
Who cannot join
- Any conditions co-morbid with ASD (e.g., fragile X)
- Significant visual, hearing or physical impairments
- Children who receive any non-oral nutritional supplementation (e.g. gastrostomy tubes)
Trial locations and contacts
1 site in 1 country.
About this study
The goal is to pilot a parent-mediated intervention for feeding challenges in children with autism building on recent research and current successful models already being used. A parent-mediated intervention would primarily occur in the home environment, working with the parent to establish goals and implement the intervention based on their child's specific needs.
Read the detailed description
Recruitment of participants:
Families will be recruited through local autism and therapy organizations, the Waisman Center Research Registry and existing studies of Autism Spectrum Disorder (ASD) and feeding. In addition, a targeted effort will be made to recruit a sample representative of the larger Madison community. A total of 50 families who have a child with a diagnosis of ASD (ages 2-7 years) and parent reported feeding problems will be recruited. Each child will be screened for eligibility based on the BAMBIC, STEP-CHILD, and a 10-item screening questionnaire developed for the study. The age range was selected to reliably confirm the ASD diagnosis, high parental involvement in feeding, and capture a small developmental range with a high prevalence of disordered feeding patterns. The diagnosis of ASD will be confirmed based on gold-standard assessment procedures: the ADOS and clinical impression under the supervision of a licensed clinical psychologist. The parent who assumes the primary role of feeding the child will be asked to participate with the child in the study. All individuals will be informed that they may withdraw participation at any time.
Procedures:
Fifty families with a child with ASD will be asked to participate in 24 parent-mediated feeding intervention visits over approximately six-months. In addition, parents will be asked to participate in 6 to 8 parent training sessions in their home or by phone. Enrollment with two groups of families will be staggered to allow for any further adaptation and refinement of the protocol based on feedback from enrolled families.
All families will be asked to participate in an initial intake session that will include an overview of the intervention program, assessment of the intervention targets, parent interview, observation/videotape of a family mealtime, and complete standardized questionnaires on specific variables (e.g., developmental level, autism severity and sensory processing) that can influence feeding behaviors to further describe the population and explore potential confounding variables. The assessments and mealtime observation will assist in determining the child's current feeding challenges and targeted goals. Both parent and child will be asked to participate in a video-taped mealtime and free play time during a laboratory session at pre and post-intervention time points. During the laboratory session, both parent and child will be asked to wear a heart rate activity monitor that attached to their chest via a harness and an electrodermal skin conductance wrist band to allow for wireless physiological data collection. In addition, parents and children will also be requested to wear the heart rate activity monitor two times in their home environment during family mealtime. Hair samples will be taken from both the parent and the child to assess recent stress levels. Parents will collaborate in Goal Attainment Scaling to allow for a pre- and post-test comparison of child specific goals. In addition, feeding assessments as well as a parent stress measure, heart rate variability, and hair cortisol measurement will be used for a pre- and post-test comparison. Parents will participate in brief structured interviews before, one time during, and immediately following completion of the program to provide feedback on the intervention.
Intervention:
- Parents will attend 8 group sessions that will be clustered in the first three quarters of the program focused on topics related to feeding challenges (e.g. goal setting, feeding development, parent-child interactions, sensory processing, behavior management, nutrition, the gastrointestinal system, and family mealtimes). Education sessions will be facilitated by the principal investigator and research team members.
- Parents will receive 6-10 individual sessions with a feeding interventionist that will support targeted goal setting, problem solving and individual coaching and feedback through video review of parent-led intervention.
- Parent-child dyads will receive 24 weekly sessions in the home that demonstrate modeling of intervention strategies and provide direct feedback of parent-led intervention. Parent satisfaction and burden will be assessed after each weekly session using a brief Likert scale questionnaire.
- Parents will be asked to commit 10-15 hours per week in the home setting to directly support targeted feeding goals and related challenges such as sensory processing that may be a barrier to successful eating. Two trained individuals with experience working with children with ASD will be hired to support facilitation of the parent-mediated intervention. Several steps will be taken to train and supervise the interventionists. In addition, a minimum of 20% of their interactions will be video-taped reviewed by the principal investigator to monitor treatment fidelity.
Analysis:
Descriptive statistics will be used to describe the family and child characteristics as well as family satisfaction. Interview data from the parents will be audio recorded, transcribed verbatim and imported into Nvivo for data management and analysis support to inform future adaptations of the intervention program as well as beginning to unravel who the program may be most effective for and why. An analysis of variance (ANOVA) will be used to assess the pre- and post-intervention differences of the key variables of interest.
- Conditions
- Parent-Child Relations, Meals, Autism Spectrum Disorder
- Being tested
- Parent-Mediated Intervention
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent-Mediated InterventionBehavioural
Children with ASD will participate in a 6-month parent-mediated intervention that will include direct intervention and parent education.
| Study group | Role | What they receive |
|---|---|---|
| Parent-Mediated Intervention with ASD | Experimental | In-home intervention (1-2x/week) will occur with families with children with ASD, including direct intervention, parent coaching, and parent training. Receives: Behavioral: Parent-Mediated Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Brief Autism Mealtime Behavior Inventory (BAMBIC)
Parent report 18 item inventory that uses a Likert scale (1 = never to 5 = always) to report frequency of mealtime problem behaviors in children. Total possible range of scores is 18-90 where higher scores indicate increased frequency of mealtime problems.
Measured: Pre/post measure through study completion, an average of 6 months
Change in Sensory Experiences Questionnaire (SEQ 3.0)
Caregiver report instrument designed to characterize sensory features in children ages 2-12 years with ASD. This is a 105-item questionnaire, the scoring is based on the first 97: scored on a 5 point scale from 1 (almost never) to 5 (almost always). The remaining items are qualitative and provide context. Total possible range of scores is 97-485, higher scores indicate greater intensity of sensory behaviors.
Measured: Pre/post measure through study completion, an average of 6 months
Change in Behavioral Pediatric Feeding Assessment Scale (BPFAS)
Parent report measure designed to identify mealtime behaviors
Measured: Pre/post measure through study completion, an average of 6 months
Change in Goal Attainment Scaling (GAS).
Assesses the effectiveness of psycho-social interventions in the community setting in ASD.
Measured: Pre/Post measure through study completion, an average of 6 months
Secondary outcomes (3)
Beck Depression Inventory-II (BDI)
Used to assess parent depression and stress.
Measured: Pre/post measure through study completion, an average of 6 months
Parenting Stress Index-Short Form (PSI-SF)
Used to assess parent depression and stress.
Measured: Pre/post measure through study completion, an average of 6 months
Change in the Caregiver Involvement Scale Score
The Caregiver Involvement Scale is a 6-item instrument scored on a 5-point likert scale for a total possible range of scores from 6-30, where higher scores indicate increased caregiver comfort and involvement with the intervention.
Measured: Pre/Post intervention session measure through study completion, an average of 1 time per month (for up to 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2017
- Study start3 Feb 2017
- Primary completion30 May 2023
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Parent-Child RelationsStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- One group, pre, post-test
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karla K Ausderau, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03071120
- Sponsor's protocol ID
- 2016-1428
- Other IDs
- A176000, EDUC\KINESIOLOGY\KINESIO
- Status last verified
- Jun 2023
- First submitted
- 15 Feb 2017
- Last updated
- 8 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kodak T, Piazza CC. Assessment and behavioral treatment of feeding and sleeping disorders in children with autism spectrum disorders. Child Adolesc Psychiatr Clin N Am. 2008 Oct;17(4):887-905, x-xi. doi: 10.1016/j.chc.2008.06.005.
PubMed 18775376Ledford JR, Gast DL. Feeding problems in children with autism spectrum disorders: A review. Focus Autism Other Dev Disabl. 2006;21(3):153-166
Marquenie K, Rodger S, Mangohig K, Cronin A. Dinnertime and bedtime routines and rituals in families with a young child with an autism spectrum disorder. Aust Occup Ther J. 2011 Jun;58(3):145-54. doi: 10.1111/j.1440-1630.2010.00896.x. Epub 2011 Jan 9.
PubMed 21599679Sharp WG, Berry RC, McCracken C, Nuhu NN, Marvel E, Saulnier CA, Klin A, Jones W, Jaquess DL. Feeding problems and nutrient intake in children with autism spectrum disorders: a meta-analysis and comprehensive review of the literature. J Autism Dev Disord. 2013 Sep;43(9):2159-73. doi: 10.1007/s10803-013-1771-5.
PubMed 23371510Kral TV, Eriksen WT, Souders MC, Pinto-Martin JA. Eating behaviors, diet quality, and gastrointestinal symptoms in children with autism spectrum disorders: a brief review. J Pediatr Nurs. 2013 Nov-Dec;28(6):548-56. doi: 10.1016/j.pedn.2013.01.008. Epub 2013 Mar 24.
PubMed 23531467Estes A, Munson J, Dawson G, Koehler E, Zhou XH, Abbott R. Parenting stress and psychological functioning among mothers of preschool children with autism and developmental delay. Autism. 2009 Jul;13(4):375-87. doi: 10.1177/1362361309105658.
PubMed 19535467Lovell B, Moss M, Wetherell MA. The psychophysiological and health corollaries of child problem behaviours in caregivers of children with autism and ADHD. J Intellect Disabil Res. 2015 Feb;59(2):150-7. doi: 10.1111/jir.12081. Epub 2013 Jul 24.
PubMed 23889770Dawson G, Rogers S, Munson J, Smith M, Winter J, Greenson J, Donaldson A, Varley J. Randomized, controlled trial of an intervention for toddlers with autism: the Early Start Denver Model. Pediatrics. 2010 Jan;125(1):e17-23. doi: 10.1542/peds.2009-0958. Epub 2009 Nov 30.
PubMed 19948568Hardan AY, Gengoux GW, Berquist KL, Libove RA, Ardel CM, Phillips J, Frazier TW, Minjarez MB. A randomized controlled trial of Pivotal Response Treatment Group for parents of children with autism. J Child Psychol Psychiatry. 2015 Aug;56(8):884-92. doi: 10.1111/jcpp.12354. Epub 2014 Oct 27.
PubMed 25346345Rogers SJ, Estes A, Lord C, Vismara L, Winter J, Fitzpatrick A, Guo M, Dawson G. Effects of a brief Early Start Denver model (ESDM)-based parent intervention on toddlers at risk for autism spectrum disorders: a randomized controlled trial. J Am Acad Child Adolesc Psychiatry. 2012 Oct;51(10):1052-65. doi: 10.1016/j.jaac.2012.08.003. Epub 2012 Aug 28.
PubMed 23021480Manikam R, Perman JA. Pediatric feeding disorders. J Clin Gastroenterol. 2000 Jan;30(1):34-46. doi: 10.1097/00004836-200001000-00007.
PubMed 10636208Winston KA, Dunbar SB, Reed CN, Francis-Connolly E. Mothering occupations when parenting children with feeding concerns: a mixed methods study. Can J Occup Ther. 2010 Jun;77(3):181-9. doi: 10.2182/cjot.2010.77.3.8.
PubMed 20597379Ahearn WH, Castine T, Nault K, Green G. An assessment of food acceptance in children with autism or pervasive developmental disorder-not otherwise specified. J Autism Dev Disord. 2001 Oct;31(5):505-11. doi: 10.1023/a:1012221026124.
PubMed 11794415Martins Y, Young RL, Robson DC. Feeding and eating behaviors in children with autism and typically developing children. J Autism Dev Disord. 2008 Nov;38(10):1878-87. doi: 10.1007/s10803-008-0583-5. Epub 2008 May 16.
PubMed 18483843Schreck KA, Williams K, Smith AF. A comparison of eating behaviors between children with and without autism. J Autism Dev Disord. 2004 Aug;34(4):433-8. doi: 10.1023/b:jadd.0000037419.78531.86.
PubMed 15449518
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parent-Mediated Intervention for Families With Children With Autism and Feeding Challenges
- ClinicalTrials.gov ID
- NCT03071120
- Acronym / sponsor ID
- 2016-1428
- Conditions
- Parent-Child Relations, Meals, Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 3 Feb 2017 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 6 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal is to pilot a parent-mediated intervention for feeding challenges in children with autism building on recent research and current successful models already being used. A parent-mediated intervention would primarily occur in the home environment, working with the parent to establish goals and implement the intervention based on their child's specific needs.
Detailed description
Recruitment of participants:
Families will be recruited through local autism and therapy organizations, the Waisman Center Research Registry and existing studies of Autism Spectrum Disorder (ASD) and feeding. In addition, a targeted effort will be made to recruit a sample representative of the larger Madison community. A total of 50 families who have a child with a diagnosis of ASD (ages 2-7 years) and parent reported feeding problems will be recruited. Each child will be screened for eligibility based on the BAMBIC, STEP-CHILD, and a 10-item screening questionnaire developed for the study. The age range was selected to reliably confirm the ASD diagnosis, high parental involvement in feeding, and capture a small developmental range with a high prevalence of disordered feeding patterns. The diagnosis of ASD will be confirmed based on gold-standard assessment procedures: the ADOS and clinical impression under the supervision of a licensed clinical psychologist. The parent who assumes the primary role of feeding the child will be asked to participate with the child in the study. All individuals will be informed that they may withdraw participation at any time.
Procedures:
Fifty families with a child with ASD will be asked to participate in 24 parent-mediated feeding intervention visits over approximately six-months. In addition, parents will be asked to participate in 6 to 8 parent training sessions in their home or by phone. Enrollment with two groups of families will be staggered to allow for any further adaptation and refinement of the protocol based on feedback from enrolled families.
All families will be asked to participate in an initial intake session that will include an overview of the intervention program, assessment of the intervention targets, parent interview, observation/videotape of a family mealtime, and complete standardized questionnaires on specific variables (e.g., developmental level, autism severity and sensory processing) that can influence feeding behaviors to further describe the population and explore potential confounding variables. The assessments and mealtime observation will assist in determining the child's current feeding challenges and targeted goals. Both parent and child will be asked to participate in a video-taped mealtime and free play time during a laboratory session at pre and post-intervention time points. During the laboratory session, both parent and child will be asked to wear a heart rate activity monitor that attached to their chest via a harness and an electrodermal skin conductance wrist band to allow for wireless physiological data collection. In addition, parents and children will also be requested to wear the heart rate activity monitor two times in their home environment during family mealtime. Hair samples will be taken from both the parent and the child to assess recent stress levels. Parents will collaborate in Goal Attainment Scaling to allow for a pre- and post-test comparison of child specific goals. In addition, feeding assessments as well as a parent stress measure, heart rate variability, and hair cortisol measurement will be used for a pre- and post-test comparison. Parents will participate in brief structured interviews before, one time during, and immediately following completion of the program to provide feedback on the intervention.
Intervention:
- Parents will attend 8 group sessions that will be clustered in the first three quarters of the program focused on topics related to feeding challenges (e.g. goal setting, feeding development, parent-child interactions, sensory processing, behavior management, nutrition, the gastrointestinal system, and family mealtimes). Education sessions will be facilitated by the principal investigator and research team members.
- Parents will receive 6-10 individual sessions with a feeding interventionist that will support targeted goal setting, problem solving and individual coaching and feedback through video review of parent-led intervention.
- Parent-child dyads will receive 24 weekly sessions in the home that demonstrate modeling of intervention strategies and provide direct feedback of parent-led intervention. Parent satisfaction and burden will be assessed after each weekly session using a brief Likert scale questionnaire.
- Parents will be asked to commit 10-15 hours per week in the home setting to directly support targeted feeding goals and related challenges such as sensory processing that may be a barrier to successful eating. Two trained individuals with experience working with children with ASD will be hired to support facilitation of the parent-mediated intervention. Several steps will be taken to train and supervise the interventionists. In addition, a minimum of 20% of their interactions will be video-taped reviewed by the principal investigator to monitor treatment fidelity.
Analysis:
Descriptive statistics will be used to describe the family and child characteristics as well as family satisfaction. Interview data from the parents will be audio recorded, transcribed verbatim and imported into Nvivo for data management and analysis support to inform future adaptations of the intervention program as well as beginning to unravel who the program may be most effective for and why. An analysis of variance (ANOVA) will be used to assess the pre- and post-intervention differences of the key variables of interest.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- One group, pre, post-test
| Arm | Type | Receives |
|---|---|---|
| Parent-Mediated Intervention with ASD | Experimental | Behavioral: Parent-Mediated InterventionIn-home intervention (1-2x/week) will occur with families with children with ASD, including direct intervention, parent coaching, and parent training. |
Who may qualify
- Ages
- 2 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Child with a confirmed diagnosis of ASD (ages 2-7 years)
- Parent reported feeding problems
- English Speaking
Key exclusion criteria (3 listed)
- Any conditions co-morbid with ASD (e.g., fragile X)
- Significant visual, hearing or physical impairments
- Children who receive any non-oral nutritional supplementation (e.g. gastrostomy tubes)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parent-Mediated InterventionChildren with ASD will participate in a 6-month parent-mediated intervention that will include direct intervention and parent education. | Behavioural | Parent-Mediated Intervention with ASD |
Primary outcome
Change in Brief Autism Mealtime Behavior Inventory (BAMBIC)
Time frame: Pre/post measure through study completion, an average of 6 months
Parent report 18 item inventory that uses a Likert scale (1 = never to 5 = always) to report frequency of mealtime problem behaviors in children. Total possible range of scores is 18-90 where higher scores indicate increased frequency of mealtime problems.
Change in Sensory Experiences Questionnaire (SEQ 3.0)
Time frame: Pre/post measure through study completion, an average of 6 months
Caregiver report instrument designed to characterize sensory features in children ages 2-12 years with ASD. This is a 105-item questionnaire, the scoring is based on the first 97: scored on a 5 point scale from 1 (almost never) to 5 (almost always). The remaining items are qualitative and provide context. Total possible range of scores is 97-485, higher scores indicate greater intensity of sensory behaviors.
Change in Behavioral Pediatric Feeding Assessment Scale (BPFAS)
Time frame: Pre/post measure through study completion, an average of 6 months
Parent report measure designed to identify mealtime behaviors
Change in Goal Attainment Scaling (GAS).
Time frame: Pre/Post measure through study completion, an average of 6 months
Assesses the effectiveness of psycho-social interventions in the community setting in ASD.
3 secondary outcomes
Beck Depression Inventory-II (BDI)
Time frame: Pre/post measure through study completion, an average of 6 months
Parenting Stress Index-Short Form (PSI-SF)
Time frame: Pre/post measure through study completion, an average of 6 months
Change in the Caregiver Involvement Scale Score
Time frame: Pre/Post intervention session measure through study completion, an average of 1 time per month (for up to 6 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2023.
- Background: PubMed 18775376Kodak T, Piazza CC. Assessment and behavioral treatment of feeding and sleeping disorders in children with autism spectrum disorders. Child Adolesc Psychiatr Clin N Am. 2008 Oct;17(4):887-905, x-xi. doi: 10.1016/j.chc.2008.06.005.
- BackgroundLedford JR, Gast DL. Feeding problems in children with autism spectrum disorders: A review. Focus Autism Other Dev Disabl. 2006;21(3):153-166
- Background: PubMed 21599679Marquenie K, Rodger S, Mangohig K, Cronin A. Dinnertime and bedtime routines and rituals in families with a young child with an autism spectrum disorder. Aust Occup Ther J. 2011 Jun;58(3):145-54. doi: 10.1111/j.1440-1630.2010.00896.x. Epub 2011 Jan 9.
- Background: PubMed 23371510Sharp WG, Berry RC, McCracken C, Nuhu NN, Marvel E, Saulnier CA, Klin A, Jones W, Jaquess DL. Feeding problems and nutrient intake in children with autism spectrum disorders: a meta-analysis and comprehensive review of the literature. J Autism Dev Disord. 2013 Sep;43(9):2159-73. doi: 10.1007/s10803-013-1771-5.
- Background: PubMed 23531467Kral TV, Eriksen WT, Souders MC, Pinto-Martin JA. Eating behaviors, diet quality, and gastrointestinal symptoms in children with autism spectrum disorders: a brief review. J Pediatr Nurs. 2013 Nov-Dec;28(6):548-56. doi: 10.1016/j.pedn.2013.01.008. Epub 2013 Mar 24.
- Background: PubMed 19535467Estes A, Munson J, Dawson G, Koehler E, Zhou XH, Abbott R. Parenting stress and psychological functioning among mothers of preschool children with autism and developmental delay. Autism. 2009 Jul;13(4):375-87. doi: 10.1177/1362361309105658.
- Background: PubMed 23889770Lovell B, Moss M, Wetherell MA. The psychophysiological and health corollaries of child problem behaviours in caregivers of children with autism and ADHD. J Intellect Disabil Res. 2015 Feb;59(2):150-7. doi: 10.1111/jir.12081. Epub 2013 Jul 24.
- Background: PubMed 19948568Dawson G, Rogers S, Munson J, Smith M, Winter J, Greenson J, Donaldson A, Varley J. Randomized, controlled trial of an intervention for toddlers with autism: the Early Start Denver Model. Pediatrics. 2010 Jan;125(1):e17-23. doi: 10.1542/peds.2009-0958. Epub 2009 Nov 30.
- Background: PubMed 25346345Hardan AY, Gengoux GW, Berquist KL, Libove RA, Ardel CM, Phillips J, Frazier TW, Minjarez MB. A randomized controlled trial of Pivotal Response Treatment Group for parents of children with autism. J Child Psychol Psychiatry. 2015 Aug;56(8):884-92. doi: 10.1111/jcpp.12354. Epub 2014 Oct 27.
- Background: PubMed 23021480Rogers SJ, Estes A, Lord C, Vismara L, Winter J, Fitzpatrick A, Guo M, Dawson G. Effects of a brief Early Start Denver model (ESDM)-based parent intervention on toddlers at risk for autism spectrum disorders: a randomized controlled trial. J Am Acad Child Adolesc Psychiatry. 2012 Oct;51(10):1052-65. doi: 10.1016/j.jaac.2012.08.003. Epub 2012 Aug 28.
- Background: PubMed 10636208Manikam R, Perman JA. Pediatric feeding disorders. J Clin Gastroenterol. 2000 Jan;30(1):34-46. doi: 10.1097/00004836-200001000-00007.
- Background: PubMed 20597379Winston KA, Dunbar SB, Reed CN, Francis-Connolly E. Mothering occupations when parenting children with feeding concerns: a mixed methods study. Can J Occup Ther. 2010 Jun;77(3):181-9. doi: 10.2182/cjot.2010.77.3.8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karla K Ausderau, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent-Mediated Intervention in people with Parent-Child Relations and Meals, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Brief Autism Mealtime Behavior Inventory (BAMBIC) (time frame: Pre/post measure through study completion, an average of 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03071120, which also lists 30 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2023.