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Family, Responsibility, Education, Support, and Health for Families With a Child With Autism (FRESH-A)

Primary Purpose

Autism Spectrum Disorder, Obesity, Childhood, Autism

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PBT-A
Health Education (HE)
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring obesity, treatment, intervention, Autism, behavioral treatment, parent based treatment, children

Eligibility Criteria

6 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: A child with OW/OB (>=85% BMI for age) aged 6-12 years Documented community diagnosis of autism The child meets cut-off criteria for autism on the Autism Diagnostic Interview-Revised (ADI-R), as well as overall DSM 5 criteria based on the clinical judgement of an experienced clinician The parent who is responsible for food preparation is willing to participate The family is willing to commit to attending all treatment and assessment sessions Child and parent are on a stable medication regimen (minimum of 3 months) Child does not have any medical conditions that limit ability to participate in physical activity for the duration of the study. Parent can participate in physical activity or at least facilitate support of child's completion of recommended physical activity. Child and/or parent are not participating in another organized weight control program Family owns a device that can facilitate zoom meetings and a device that can facilitate video recording Exclusion Criteria: Child diagnoses of a serious chronic physical disease (e.g., cystic fibrosis, type 1 diabetes) for which physician supervision of diet and/or exercise is needed Child or first degree relative with diagnosis of anorexia or bulimia nervosa based on parent report Acute parent psychiatric disorder (e.g., acute suicidality; recent hospitalization; psychosis, moderate or severe alcohol or substance use disorder) that could interfere with treatment. Parent is not currently pregnant, lactating or planning to get pregnant during the study duration Parent has had bariatric surgery less than 6 months ago and/or is not yet eating solid food or is planning to have bariatric surgery over the study duration

Sites / Locations

  • UC San Diego Center for Healthy Eating and Activity Research (CHEAR)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PBT-A

Health Education

Arm Description

PBT-A includes the elements of family based behavioral treatment for children with obesity, delivered exclusively to a parent via telehealth.

This program provides information about nutrition, physical activity, sedentary behavior, sleep, emotions, and stress delivered exclusively to a parent via telehealth.

Outcomes

Primary Outcome Measures

Child BMIz age and sex adjusted BMI (kg/m^2)
age and sex adjusted body mass index (BMI) z-score based on the CDC norms
Child %BMIp95
Age and Sex specific percentage of the 95th percentile BMI for age and sex that is more sensitive to change in children with higher weights

Secondary Outcome Measures

Parent Dietary Intake
Block Fat/Sugar/Fruit/Vegetable Screener for adults
Child Dietary Intake
BLOCK kids food screener completed by parent
Parent Physical Activity
The International Physical Activity Questionnaire (IPAQ)
Child Physical Activity
The Children's Physical Activity Questionnaire (C-PAQ) parent proxy
Child Mealtime Behaviors at home
Measured by video coding of a family meal
Child Mealtime Behaviors
The Brief Autism Mealtime Behavior Inventory (BAMBI) with scores ranging from 18 to 90 with higher scores indicating greater mealtime problem behaviors
Parenting style
The Parenting Scale. The total score will range from 1-7 with lower scores representing higher scores representing more dysfunctional parenting
Parent self-efficacy
The Parenting Sense of Competence Scale (PSOC) - Scores range from 17-102 with higher scores representing higher parenting sense of competence.
Parent body mass index (BMI)
kg/m^2

Full Information

First Posted
February 13, 2023
Last Updated
August 24, 2023
Sponsor
University of California, San Diego
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT05741840
Brief Title
Family, Responsibility, Education, Support, and Health for Families With a Child With Autism
Acronym
FRESH-A
Official Title
Telehealth Parent-only Treatment for Youth With Autism Spectrum Disorder and Overweight/Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 18, 2023 (Actual)
Primary Completion Date
June 2027 (Anticipated)
Study Completion Date
June 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The objective of this proposed study is to collect initial efficacy data on a telehealth parent-based behavioral program for children with autism and overweight or obesity (PBT-A), compared with health education (HE).
Detailed Description
The study will compare the efficacy of PBT-A and health education program delivered via telehealth to parents on child weight management. Investigators will provide 6 months of a group program (PBT-A or HE) and will follow participants for 12-months post-treatment (total time = 18 months). Investigators will recruit parents of children diagnosed with autism and overweight or obesity. Assessments will occur at 5 timepoints: baseline, mid-treatment, post-treatment, 6-month and 12-month follow-up. Assessments will include anthropometry for both parent and child. Parent will also provide information regarding autism diagnosis and characteristics, eating behaviors, and parenting relationship measures. This program of research has the potential to advance the standard of practice for children with autism and overweight or obesity by developing tailored interventions which can be easily disseminated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder, Obesity, Childhood, Autism
Keywords
obesity, treatment, intervention, Autism, behavioral treatment, parent based treatment, children

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PBT-A
Arm Type
Experimental
Arm Description
PBT-A includes the elements of family based behavioral treatment for children with obesity, delivered exclusively to a parent via telehealth.
Arm Title
Health Education
Arm Type
Active Comparator
Arm Description
This program provides information about nutrition, physical activity, sedentary behavior, sleep, emotions, and stress delivered exclusively to a parent via telehealth.
Intervention Type
Behavioral
Intervention Name(s)
PBT-A
Other Intervention Name(s)
parent based treatment, family based behavioral treatment
Intervention Description
PBT-A provides all the elements of family based treatment for children with obesity, including nutrition and physical activity education, behavior therapy skills, and parenting skills.
Intervention Type
Behavioral
Intervention Name(s)
Health Education (HE)
Intervention Description
The HE arm will provide information about nutrition, physical activity, sedentary behavior, sleep, emotions, and stress.
Primary Outcome Measure Information:
Title
Child BMIz age and sex adjusted BMI (kg/m^2)
Description
age and sex adjusted body mass index (BMI) z-score based on the CDC norms
Time Frame
Change from baseline to month 3, 6, 12, and 18
Title
Child %BMIp95
Description
Age and Sex specific percentage of the 95th percentile BMI for age and sex that is more sensitive to change in children with higher weights
Time Frame
Change from baseline to month 3, 6, 12, and 18
Secondary Outcome Measure Information:
Title
Parent Dietary Intake
Description
Block Fat/Sugar/Fruit/Vegetable Screener for adults
Time Frame
Change from baseline to month 6, 12, and 18
Title
Child Dietary Intake
Description
BLOCK kids food screener completed by parent
Time Frame
Change from baseline to month 6, 12, and 18
Title
Parent Physical Activity
Description
The International Physical Activity Questionnaire (IPAQ)
Time Frame
Change from baseline to month 6, 12, and 18
Title
Child Physical Activity
Description
The Children's Physical Activity Questionnaire (C-PAQ) parent proxy
Time Frame
Change from baseline to month 6, 12, and 18
Title
Child Mealtime Behaviors at home
Description
Measured by video coding of a family meal
Time Frame
Change from baseline to month 6, 12, and 18
Title
Child Mealtime Behaviors
Description
The Brief Autism Mealtime Behavior Inventory (BAMBI) with scores ranging from 18 to 90 with higher scores indicating greater mealtime problem behaviors
Time Frame
Change from baseline to month 6, 12, and 18
Title
Parenting style
Description
The Parenting Scale. The total score will range from 1-7 with lower scores representing higher scores representing more dysfunctional parenting
Time Frame
Change from baseline to month 6, 12, and 18
Title
Parent self-efficacy
Description
The Parenting Sense of Competence Scale (PSOC) - Scores range from 17-102 with higher scores representing higher parenting sense of competence.
Time Frame
Change from baseline to month 6, 12, and 18
Title
Parent body mass index (BMI)
Description
kg/m^2
Time Frame
Change from baseline to mid-treatment, months: 3, 6, 12, and 18

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: A child with OW/OB (>=85% BMI for age) aged 6-12 years Documented community diagnosis of autism The child meets cut-off criteria for autism on the Autism Diagnostic Interview-Revised (ADI-R), as well as overall DSM 5 criteria based on the clinical judgement of an experienced clinician The parent who is responsible for food preparation is willing to participate The family is willing to commit to attending all treatment and assessment sessions Child and parent are on a stable medication regimen (minimum of 3 months) Child does not have any medical conditions that limit ability to participate in physical activity for the duration of the study. Parent can participate in physical activity or at least facilitate support of child's completion of recommended physical activity. Child and/or parent are not participating in another organized weight control program Family owns a device that can facilitate zoom meetings and a device that can facilitate video recording Exclusion Criteria: Child diagnoses of a serious chronic physical disease (e.g., cystic fibrosis, type 1 diabetes) for which physician supervision of diet and/or exercise is needed Child or first degree relative with diagnosis of anorexia or bulimia nervosa based on parent report Acute parent psychiatric disorder (e.g., acute suicidality; recent hospitalization; psychosis, moderate or severe alcohol or substance use disorder) that could interfere with treatment. Parent is not currently pregnant, lactating or planning to get pregnant during the study duration Parent has had bariatric surgery less than 6 months ago and/or is not yet eating solid food or is planning to have bariatric surgery over the study duration
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Recruitment Coordinator
Phone
8558273498
Email
chear@health.ucsd.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kerri Boutelle, Ph.D.
Phone
8585348037
Email
kboutelle@health.ucsd.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kerri Boutelle, PhD
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC San Diego Center for Healthy Eating and Activity Research (CHEAR)
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kerri Boutelle, Ph.D.
Phone
858-534-8037
Email
kboutelle@health.ucsd.edu

12. IPD Sharing Statement

Learn more about this trial

Family, Responsibility, Education, Support, and Health for Families With a Child With Autism

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