Child MaltreatmentNCT02742831
A Pilot Intervention With Families of Children With Special Health Care Needs
A study testing Intervention in people with Child Maltreatment and Children With Special Health Care Needs (CSHCN), run by Boston Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Child Maltreatment, Children With Special Health Care Needs (CSHCN)
- What is being tested?
- Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2017to Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Prior history of substantiated child maltreatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Theory-Based Intervention to Prevent Child Neglect in High-Risk
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.
Read the detailed description
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.
- Being tested
- Intervention, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionBehavioural
The intervention group will receive a 6-session intervention. The overview of the 6 sessions is as follows:
- "Behavioral chain analysis" of episode where parent felt stressed with child and episode where things went well. Identification of sources of interpersonal support.
- Stress relief techniques. Identification of short and long-term goals. Development of a detailed crisis plan.
- Problem solving techniques.
- Emotional regulation. Exercises to identify moods and explore connections between feelings, thoughts, and behavior.
- Positive parenting, review of common and specific parenting challenges, child development, short and long-term effects of different discipline approaches.
- Reflection, repeat behavioral chain analysis. Update crisis plan.
ControlOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Behavioral: Intervention |
| Control | Active comparator | 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. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study Logistics - subject enrollment
As this is a pilot study, the primary objective is to field test study logistics, including subject enrollment. The investigators will review monthly counts of enrolled subjects from baseline to 12 months post-randomization, and will compare the number of subjects in each study arm to target enrollment goals. Because of emerging consensus that group-to-group comparisons in a pilot study are not only invalid but also misleading, estimating effect size is deliberately not our primary study objective.
Measured: Monthly change from baseline to 12 months post randomization
Study Logistics - fidelity of intervention delivery
For the intervention group, treatment fidelity will be assessed by audio taping a random 10% of sessions and scoring them with standardized instruments. The investigators will measure the proportion of sessions delivered with fidelity. Because of emerging consensus that group-to-group comparisons in a pilot study are not only invalid but also misleading, estimating effect size is deliberately not our primary study objective.
Measured: 3 months post randomization
Secondary outcomes (6)
Re-referral to child protection team or social services
The investigators will obtain empirical estimates of the proportion of control group subjects to be re-referred to child protection team or social services by 3 months post randomization. This will allow the investigators to power a later study for this dichotomous outcome.
Measured: 3 months post randomization
Re-referral to child protection team or social services
The investigators will obtain empirical estimates of the proportion of control group subjects to be re-referred to child protection team or social services by 6 months post randomization. This will allow the investigators to power a later study for this dichotomous outcome.
Measured: 6 months post randomization
Re-referral to child protection team or social services
The investigators will obtain empirical estimates of the proportion of control group subjects to be re-referred to child protection team or social services by 12 months post randomization. This will allow the investigators to power a later study for this dichotomous outcome.
Measured: 12 months post randomization
Adherence to recommended medical care
The investigators will conduct chart review to count the number of missed medical appointments, emergency department visits, and hospitalizations in the 90 days preceding the analysis. The investigators will specifically examine the proportion of control group subjects to experience each outcome and will use this data to power a later study.
Measured: 3 months post randomization
Adherence to recommended medical care
The investigators will conduct chart review to count the number of missed medical appointments, emergency department visits, and hospitalizations in the 90 days preceding the analysis. The investigators will specifically examine the proportion of control group subjects to experience each outcome and will use this data to power a later study.
Measured: 6 months post randomization
Adherence to recommended medical care
The investigators will conduct chart review to count the number of missed medical appointments, emergency department visits, and hospitalizations in the 90 days preceding the analysis. The investigators will specifically examine the proportion of control group subjects to experience each outcome and will use this data to power a later study.
Measured: 12 months post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2016 (estimated)
- Study start1 Aug 2017
- Primary completionAug 2018 (estimated)
- Study completionAug 2018 (estimated)
Why it stopped: No subjects were enrolled and the grant period is ending.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child MaltreatmentStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Caroline Kistin, Boston Medical Center
- Investigators
- Caroline J Kistin, MD, MSc, Principal investigator, Boston University School of Medicine/Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02742831
- Sponsor's protocol ID
- H-35105
- Other IDs
- 1K23HD078503-01A1
- Status last verified
- Aug 2018
- First submitted
- 5 Apr 2016
- Last updated
- 14 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Theory-Based Intervention to Prevent Child Neglect in High-Risk
- ClinicalTrials.gov ID
- NCT02742831
- Acronym / sponsor ID
- H-35105
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No subjects were enrolled and the grant period is ending.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 19 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: InterventionThe 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. |
| Control | Active comparator | Other: ControlThe 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Prior history of substantiated child maltreatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterventionThe 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. | Behavioural | Intervention |
| ControlThe 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. | Other | Control |
Primary outcome
Study Logistics - subject enrollment
Time frame: Monthly change from baseline to 12 months post randomization
As this is a pilot study, the primary objective is to field test study logistics, including subject enrollment. The investigators will review monthly counts of enrolled subjects from baseline to 12 months post-randomization, and will compare the number of subjects in each study arm to target enrollment goals. Because of emerging consensus that group-to-group comparisons in a pilot study are not only invalid but also misleading, estimating effect size is deliberately not our primary study objective.
Study Logistics - fidelity of intervention delivery
Time frame: 3 months post randomization
For the intervention group, treatment fidelity will be assessed by audio taping a random 10% of sessions and scoring them with standardized instruments. The investigators will measure the proportion of sessions delivered with fidelity. Because of emerging consensus that group-to-group comparisons in a pilot study are not only invalid but also misleading, estimating effect size is deliberately not our primary study objective.
6 secondary outcomes
Re-referral to child protection team or social services
Time frame: 3 months post randomization
Re-referral to child protection team or social services
Time frame: 6 months post randomization
Re-referral to child protection team or social services
Time frame: 12 months post randomization
Adherence to recommended medical care
Time frame: 3 months post randomization
Adherence to recommended medical care
Time frame: 6 months post randomization
Adherence to recommended medical care
Time frame: 12 months post randomization
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caroline J Kistin, MD, MSc principal investigator
Boston University School of Medicine/Boston Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Child Maltreatment and Children With Special Health Care Needs (CSHCN), run by Boston Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study Logistics - subject enrollment (time frame: Monthly change from baseline to 12 months post randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2018.