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NCT Number: NCT05741840

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

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

La Jolla, California, 92037, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • A child with OW/OB (>=85% BMI for age) aged 6-12 years
  • Documented (1) community diagnosis or provisional diagnosis of ASD or (2) educational diagnosis of ASD
  • 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 on a stable regimen of prescription medications which affect appetite or weight (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

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
  • Child is taking medication for the purpose of weight loss

Treatment and study plan

PBT-A

Behavioral

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.

Other names: parent based treatment, family based behavioral treatment

Health Education (HE)

Behavioral

The HE arm will provide information about nutrition, physical activity, sedentary behavior, sleep, emotions, and stress.

Primary outcomes

  1. Child BMIz age and sex adjusted BMI (kg/m^2)

    Time frame: Change from baseline to month 3, 6, 12, and 18

    age and sex adjusted body mass index (BMI) z-score based on the CDC norms

  2. Child %BMIp95

    Time frame: Change from baseline to month 3, 6, 12, and 18

    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 outcomes

  1. Parent Dietary Intake

    Time frame: Change from baseline to month 6, 12, and 18

    Block Fat/Sugar/Fruit/Vegetable Screener for adults

  2. Child Dietary Intake

    Time frame: Change from baseline to month 6, 12, and 18

    BLOCK kids food screener completed by parent

  3. Parent Physical Activity

    Time frame: Change from baseline to month 6, 12, and 18

    The International Physical Activity Questionnaire (IPAQ)

  4. Child Physical Activity

    Time frame: Change from baseline to month 6, 12, and 18

    The Children's Physical Activity Questionnaire (C-PAQ) parent proxy

  5. Child Mealtime Behaviors

    Time frame: Change from baseline to month 6, 12, and 18

    The Brief Autism Mealtime Behavior Inventory (BAMBI) with scores ranging from 18 to 90 with higher scores indicating greater mealtime problem behaviors

  6. Parent self-efficacy

    Time frame: Change from baseline to month 6, 12, and 18

    The Parenting Sense of Competence Scale (PSOC) - Scores range from 17-102 with higher scores representing higher parenting sense of competence.

  7. Parent body mass index (BMI)

    Time frame: Change from baseline to mid-treatment, months: 3, 6, 12, and 18

    kg/m^2

  8. Parenting as measured by the Alabama Parenting Questionnaire (APQ)

    Time frame: Change from baseline to month 6, 12, and 18

    Parents will self-report parenting behaviors via the APQ across 5 domains: 1) positive involvement with children, 2) supervision and monitoring, 3) use of positive discipline techniques, 4) consistency in the use of such discipline, and 5) use of corporal punishment. Higher scores indicate greater frequency of engagement with that particular parenting domain. Scores range from 1-5.

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

Telehealth Parent-only Treatment for Youth With Autism Spectrum Disorder and Overweight/Obesity

Acronym: FRESH-A

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Feb 23, 2023
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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