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Parent-Based Prevention (PBP) for Parents With Eating Disorders (PBP)

Primary Purpose

Eating Disorders, Eating Behavior

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Parent-based prevention
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Eating Disorders focused on measuring Secondary prevention, Parent-based prevention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • A biological parent of a child between 1-5 years of age.
  • A lifetime diagnosis of an eating disorder.

Exclusion Criteria:

* Current medical condition necessitating more intensive care to manage symptoms.

Sites / Locations

  • Stanford University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Parent based prevention

Usual care

Arm Description

Parent-Based Prevention (PBP; Sadeh-Sharvit & Lock, 2018) is a manualized preventive intervention, focused on increasing parental awareness and competence to facilitate healthy eating habits, body image, and self-regulation in children whose parent has an eating disorder history. PBP is comprised of three phases that focus on unique goals. The strategies in each session include psycho-education, behavioral experiment planning, and skill practicing to augment parents' insight into how the context of the parental cognitions and behaviors may impact child outcomes, with the goal of creating a longstanding effect.

Families randomized to usual care will be permitted to utilize any medical, psychological, or nutritional services they desire for the waitlist period of 16 weeks.

Outcomes

Primary Outcome Measures

Feasibility of recruiting parents with a lifetime diagnosis of an eating disorder: Number of eligible participants that agree to participate in the study
Number of eligible participants that agree to participate in the study
Acceptability of the intervention: Client Satisfaction Questionnaire score
Mean Client Satisfaction Questionnaire score at end of treatment. Scores range on a Likert-like scale of 1-5, with higher scores indicative of greater satisfaction.

Secondary Outcome Measures

Parental feeding practices
Change scores of the Child Feeding Questionnaire from baseline to end of treatment. Scores range on a Likert-like scale of 1-5, with higher scores indicative of the parent endorsing more frequent behaviors on the dimension measured.
Child eating behaviors
Change scores of the Children's Eating Behavior Questionnaire from baseline to end of treatment. Scores range on a Likert-like scale of 1-4, with higher scores indicative of greater endorsement of the behavior measured.

Full Information

First Posted
January 31, 2020
Last Updated
May 25, 2020
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT04254068
Brief Title
Parent-Based Prevention (PBP) for Parents With Eating Disorders
Acronym
PBP
Official Title
Preventing Feeding and Eating Disorders in Children of Parents With Eating Disorders: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
January 24, 2014 (Actual)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
December 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

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

5. Study Description

Brief Summary
Parents with eating disorders exhibit greater concerns and dilemmas about developing healthy habits in their children. Studies indicate that the offspring of parents with eating disorders have more developmental and interpersonal difficulties. Consequently, these parents should receive personalized care to enhance their parental capacity and support them in their decision making process. The Parent-Based Prevention of Eating Disorders (PBP) is a promising intervention that may help improve feeding and eating practices and children outcomes, by engaging both parents in a short-term program. This study aims to empirically evaluate the feasibility and acceptability of PBP over a wait-list control group (i.e., treatment-as-usual) in a Randomized Case Series Trial.
Detailed Description
A parental history of an eating disorder is linked with greater risk of eating and socio-emotional problems in the offspring, and more stressful parent-child interactions. Further, parenting concerns often exacerbate existing eating disorder symptoms in parents. Parent-Based Prevention (PBP-B) is a focused intervention aimed to support parents with eating disorders and their partners in developing healthy eating and lifestyle behaviors in their children. The program also focuses on reducing mealtime conflict and improving couple communication. This study tests the feasibility, acceptability and preliminary outcomes of the Parent-Based Prevention (PBP) program for these parents and their partners. Parents with any lifetime eating disorder diagnosis who have at least one child 1-5 years old will be randomized to receive PBP immediately or following a 16-week waitlist period. This study will investigate whether PBP is feasible, acceptable, and associated with improvement in short-term outcomes that predict long term risks of eating and weight disorders (e.g., parental cognition associated with feeding practices and child eating behaviors and socio-emotional symptoms). The study will collect important case series data that will inform the design of larger, adequately powered studies to test ways to reduce the likelihood of eating and weight difficulties in the offspring of parents with eating disorders.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Disorders, Eating Behavior
Keywords
Secondary prevention, Parent-based prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized case series trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Parent based prevention
Arm Type
Experimental
Arm Description
Parent-Based Prevention (PBP; Sadeh-Sharvit & Lock, 2018) is a manualized preventive intervention, focused on increasing parental awareness and competence to facilitate healthy eating habits, body image, and self-regulation in children whose parent has an eating disorder history. PBP is comprised of three phases that focus on unique goals. The strategies in each session include psycho-education, behavioral experiment planning, and skill practicing to augment parents' insight into how the context of the parental cognitions and behaviors may impact child outcomes, with the goal of creating a longstanding effect.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Families randomized to usual care will be permitted to utilize any medical, psychological, or nutritional services they desire for the waitlist period of 16 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Parent-based prevention
Other Intervention Name(s)
PBP
Intervention Description
Parent-based prevention is a 12 session program for parents with eating disorders and their partners. Most sessions occur on a weekly basis, most of the sessions involve both partners.
Primary Outcome Measure Information:
Title
Feasibility of recruiting parents with a lifetime diagnosis of an eating disorder: Number of eligible participants that agree to participate in the study
Description
Number of eligible participants that agree to participate in the study
Time Frame
Up to 48 months
Title
Acceptability of the intervention: Client Satisfaction Questionnaire score
Description
Mean Client Satisfaction Questionnaire score at end of treatment. Scores range on a Likert-like scale of 1-5, with higher scores indicative of greater satisfaction.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Parental feeding practices
Description
Change scores of the Child Feeding Questionnaire from baseline to end of treatment. Scores range on a Likert-like scale of 1-5, with higher scores indicative of the parent endorsing more frequent behaviors on the dimension measured.
Time Frame
Baseline and Week 12
Title
Child eating behaviors
Description
Change scores of the Children's Eating Behavior Questionnaire from baseline to end of treatment. Scores range on a Likert-like scale of 1-4, with higher scores indicative of greater endorsement of the behavior measured.
Time Frame
Baseline and Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: A biological parent of a child between 1-5 years of age. A lifetime diagnosis of an eating disorder. Exclusion Criteria: * Current medical condition necessitating more intensive care to manage symptoms.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shiri Sadeh-Sharvit, PhD
Organizational Affiliation
s
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Parent-Based Prevention (PBP) for Parents With Eating Disorders

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