A Pilot Intervention With Families of Children With Special Health Care Needs

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-01

Study Completion Date

2018-08-31

Brief Summary

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This is a pilot randomized controlled trial of a behavioral intervention focused on improving parenting skills and preventing child neglect in families of children with special health care needs. The intervention focuses on problem solving, distress tolerance, and emotional regulation skills.

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Detailed Description

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This pilot randomized controlled trial will be conducted with 60 caregivers of children with special health care needs who have been reported to the child protection team at Boston Medical Center with concern for neglect that was ultimately not substantiated. Half of the subjects will be randomly assigned to receive the 6-session, one-on-one, in-person, behavioral intervention focused on problem solving, emotional regulation, and distress tolerance. The other half will be randomly assigned to the control group and will receive periodic check-ins and referrals to community resources as needed. Both groups will be followed for 12 months after randomization.

Children who have previously experienced neglect, or other forms of maltreatment, will not included in the study. Children will be defined as having special health care needs if they have a chronic physical, emotional, or behavioral condition.

With this pilot, the investigators aim to field-test study mechanics, including enrollment, randomization, and the collection of baseline and follow-up data; and obtain empiric estimates of study parameters to inform a subsequent fully-powered randomized controlled trial.

Conditions

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Child Maltreatment Children With Special Health Care Needs (CSHCN)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention

The intervention group will receive a one-on-one in-person intervention of 6 sessions, each lasting approximately 60 minutes. The intervention is intended to be delivered over a period of 12 weeks, with sessions occurring every 1-2 weeks. The overview of the 6 sessions is as follows:

1. Behavioral chain analysis of episodes where parent felt stressed and episode where things went well. Identification of sources of interpersonal support.
2. Stress relief. Development of a detailed crisis plan.
3. Problem solving techniques.
4. Emotional regulation exercises.
5. Positive parenting, review of parenting challenges.
6. Reflection, repeat behavioral chain analysis. Update crisis plan.

Group Type EXPERIMENTAL

Intervention

Intervention Type BEHAVIORAL

The intervention group will receive a 6-session intervention. The overview of the 6 sessions is as follows:

1. "Behavioral chain analysis" of episode where parent felt stressed with child and episode where things went well. Identification of sources of interpersonal support.
2. Stress relief techniques. Identification of short and long-term goals. Development of a detailed crisis plan.
3. Problem solving techniques.
4. Emotional regulation. Exercises to identify moods and explore connections between feelings, thoughts, and behavior.
5. Positive parenting, review of common and specific parenting challenges, child development, short and long-term effects of different discipline approaches.
6. Reflection, repeat behavioral chain analysis. Update crisis plan.

Control

The families in the control group will be contacted by a member of the study team 6 times in 12 weeks to approximate the frequency of contact that the intervention group receives. The study team member will check in with families on the telephone or in person and will help them connect with clinic and community resources as needed.

Group Type ACTIVE_COMPARATOR

Control

Intervention Type OTHER

The families in the control group will be contacted by a member of the study team 6 times in 12 weeks to approximate the frequency of contact that the intervention group receives. The study team member will check in with families on the telephone or in person and will help them connect with clinic and community resources as needed.

Interventions

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Intervention

The intervention group will receive a 6-session intervention. The overview of the 6 sessions is as follows:

1. "Behavioral chain analysis" of episode where parent felt stressed with child and episode where things went well. Identification of sources of interpersonal support.
2. Stress relief techniques. Identification of short and long-term goals. Development of a detailed crisis plan.
3. Problem solving techniques.
4. Emotional regulation. Exercises to identify moods and explore connections between feelings, thoughts, and behavior.
5. Positive parenting, review of common and specific parenting challenges, child development, short and long-term effects of different discipline approaches.
6. Reflection, repeat behavioral chain analysis. Update crisis plan.

Intervention Type BEHAVIORAL

Control

The families in the control group will be contacted by a member of the study team 6 times in 12 weeks to approximate the frequency of contact that the intervention group receives. The study team member will check in with families on the telephone or in person and will help them connect with clinic and community resources as needed.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Primary caregiver of a child under age 7 with a special health care need, defined as a chronic physical, emotional, or behavioral health condition
* Child has been referred to the Child Protection Team for neglect that was ultimately not substantiated
* Fluent in English or Spanish