Parent-Mediated Intervention for Families With Children With Autism and Feeding Challenges
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|ClinicalTrials.gov Identifier: NCT03071120|
Recruitment Status : Recruiting
First Posted : March 6, 2017
Last Update Posted : June 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Parent-Child Relations Meals Autism Spectrum Disorder||Behavioral: Parent-Mediated Intervention||Not Applicable|
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 seventeen 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.
- 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 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.
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||One group, pre, post-test|
|Masking:||None (Open Label)|
|Official Title:||Parent-Mediated Intervention for Families With Children With Autism and Feeding Challenges|
|Actual Study Start Date :||February 3, 2017|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||February 2019|
Experimental: Parent-Mediated Intervention with ASD
In-home intervention (1-2x/week) will occur with families with children with ASD, including direct intervention, parent coaching, and parent training.
Behavioral: Parent-Mediated Intervention
Children with ASD will participate in a 6-month parent-mediated intervention that will include direct intervention and parent education.
- 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 to report frequency of mealtime problem behaviors in children
- 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
- 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.
- Beck Depression Inventory-II (BDI) [ Time Frame: Pre/post measure through study completion, an average of 6 months ]Used to assess parent depression and stress.
- Parenting Stress Index-Short Form (PSI-SF) [ Time Frame: Pre/post measure through study completion, an average of 6 months ]Used to assess parent depression and stress.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03071120
|Contact: Karla K Ausderau, Ph.D||(310) firstname.lastname@example.org|
|Contact: Sigan Hartley, Ph. D|
|United States, Wisconsin|
|Madison, Wisconsin, United States, 53705|
|Contact: Karla Ausderau, PhD, OTD 310-428-8398 email@example.com|
|Principal Investigator:||Karla K Ausderau, PhD||University of Wisconsin, Madison|