Parent-Mediated Intervention for Families With Children With Autism and Feeding Challenges
Condition: Parent-Child Relations; Meals; Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional

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 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:

        1. 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.

        2. 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.

        3. 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.

        4. 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.
    

Intervention name(s): Parent-Mediated Intervention
Intervention type(s): Behavioral
Intervention description(s): Children with ASD will participate in a 6-month parent-mediated intervention that will include direct intervention and parent education.
Intervention model: Single Group Assignment
Intervention model description: One group, pre, post-test
Masking: None (Open Label)
Primary purpose: Treatment