Hearing LossNCT03483428
Adaptation and Pilot Testing of a Behavioral Parent Training Program for Parents of Deaf and Hard of Hearing Children
A study testing Interventionist training and supervision and Behavioral parent training in people with Hearing Loss and Behavior Disorders, run by University of Kentucky at 1 site in United States.
Trial summary
Despite being more likely than typical hearing children to experience disruptive behavior problems, children who are deaf and hard of hearing (DHH) rarely receive behavioral interventions to prevent the long-term costly outcomes of behavior problems. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Hearing Loss, Behavior Disorders, Parenting
- What is being tested?
- Interventionist training and supervision and Behavioral parent training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2018to 13 Dec 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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Parent/caregiver is age 18 years or older
- Parent/caregiver is the custodial guardian of a deaf or hard of hearing (DHH) child
- DHH child is 2-5 years old
- DHH child has used hearing aid(s) and/or cochlear implant(s) for > 6 months
- Parent/caregiver is able to read English and either speak/understand English or use American Sign Language
- Age 18 years or older
- Parent of a DHH child
- Able to speak, understand, and read English
Who cannot join
- Active child protective services case
- DHH child of interest has been diagnosed with a severe developmental delay, severe autism, debilitating neurological condition, etc.
- Parent/caregiver has already accessed behavioral health services for the DHH child
- Parent Coaches/Interventionists:
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adaptation and Pilot Implementation of the Family Check-Up for Deaf and Hard of Hearing Children
Despite being more likely than typical hearing children to experience disruptive behavior problems, children who are deaf and hard of hearing (DHH) rarely receive behavioral interventions to prevent the long-term costly outcomes of behavior problems. This pilot project will systematically adapt an evidence-based behavioral parent training (BPT) intervention to increase its acceptability and relevance for parents of young DHH children. Two parents of DHH children will be trained in the adapted BPT for DHH children. They will each deliver the intervention to five families with DHH preschool-aged children.
- Conditions
- Hearing Loss, Behavior Disorders, Parenting
- Being tested
- Interventionist training and supervision, Behavioral parent training
- Medical subject headings
- Hearing Loss, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interventionist training and supervisionBehavioural
Online and in-person training and weekly supervision with licensed clinical social worker while delivering the "Family Check-Up" to 5 families.
Behavioral parent trainingBehavioural
Up to 6 sessions of the "Family Check-Up" program, involving discussions, assessments, feedback, and skills training with a parent coach.
| Study group | Role | What they receive |
|---|---|---|
| Parent Coaches | Experimental | Parent coaches will complete interventionist training and supervision in the "Family Check-Up," an evidence-based behavioral parent training (BPT) program, including in the adaptations for families with DHH children. Each parent coach will deliver the intervention to 5 parent-child dyads. Receives: Behavioral: Interventionist training and supervision |
| Parent-Child Dyads | Experimental | Parents and children will receive the adapted "Family Check-Up" behavioral parent training (BPT) intervention delivered by parent coaches. Receives: Behavioral: Behavioral parent training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: Enrollment
Proportion of parents agreeing to enroll in the intervention out of all parents approached
Measured: 2 weeks after final parent-child dyad completes the study
Secondary outcomes (5)
Feasibility: Number of sessions completed
Number of sessions completed by each enrolled parent
Measured: 2 weeks after final parent-child dyad completes the study
Interventionist fidelity
Fidelity ratings of two recorded sessions per interventionist
Measured: 2 weeks after final parent-child dyad completes the study
Feasibility: usability of battery of measures
Proportion of missing data across and within instruments for parent, child, and interventionist outcome measures
Measured: 2 weeks after final parent-child dyad completes the study
Acceptability: parent satisfaction
European Parent Satisfaction Scale about Early Intervention (EPASSEI) - adapted; range: 20 (high satisfaction) to 100 (low satisfaction)
Measured: 10 weeks after parent baseline
Acceptability: interventionist satisfaction
Therapist Satisfaction Index (TSI)
Measured: 2 weeks after final parent-child dyad completes the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2018
- Study start11 Apr 2018
- Primary completion13 Dec 2018
- Study completion13 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kentucky
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christina Studts, University of Kentucky
- Investigators
- Christina Studts, PhD, Principal investigator, University of Kentucky, Dept of Health, Behavior & SocietyMatthew Bush, MD, PhD, Principal investigator, University of Kentucky, Dept of Otolaryngology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03483428
- Sponsor's protocol ID
- 17-0460-F6A
- Status last verified
- Apr 2019
- First submitted
- 23 Mar 2018
- Last updated
- 17 Apr 2019
- 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 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation and Pilot Implementation of the Family Check-Up for Deaf and Hard of Hearing Children
- ClinicalTrials.gov ID
- NCT03483428
- Acronym / sponsor ID
- 17-0460-F6A
- Conditions
- Hearing Loss, Behavior Disorders, Parenting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of KentuckyUniversity, hospital or other
- Study start
- 11 Apr 2018 (actual)
- Primary completion
- 13 Dec 2018 (actual)
- Study completion
- 13 Dec 2018 (actual)
- First posted
- 30 Mar 2018 (actual)
- 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.
Despite being more likely than typical hearing children to experience disruptive behavior problems, children who are deaf and hard of hearing (DHH) rarely receive behavioral interventions to prevent the long-term costly outcomes of behavior problems. This pilot project will systematically adapt an evidence-based behavioral parent training (BPT) intervention to increase its acceptability and relevance for parents of young DHH children. Two parents of DHH children will be trained in the adapted BPT for DHH children. They will each deliver the intervention to five families with DHH preschool-aged children.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parent Coaches | Experimental | Behavioral: Interventionist training and supervisionParent coaches will complete interventionist training and supervision in the "Family Check-Up," an evidence-based behavioral parent training (BPT) program, including in the adaptations for families with DHH children. Each parent coach will deliver the intervention to 5 parent-child dyads. |
| Parent-Child Dyads | Experimental | Behavioral: Behavioral parent trainingParents and children will receive the adapted "Family Check-Up" behavioral parent training (BPT) intervention delivered by parent coaches. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Parent/caregiver is age 18 years or older
- Parent/caregiver is the custodial guardian of a deaf or hard of hearing (DHH) child
- DHH child is 2-5 years old
- DHH child has used hearing aid(s) and/or cochlear implant(s) for > 6 months
- Parent/caregiver is able to read English and either speak/understand English or use American Sign Language
Key exclusion criteria (5 listed)
- Active child protective services case
- DHH child of interest has been diagnosed with a severe developmental delay, severe autism, debilitating neurological condition, etc.
- Parent/caregiver has already accessed behavioral health services for the DHH child
- None
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 |
|---|---|---|
| Interventionist training and supervisionOnline and in-person training and weekly supervision with licensed clinical social worker while delivering the "Family Check-Up" to 5 families. | Behavioural | Parent Coaches |
| Behavioral parent trainingUp to 6 sessions of the "Family Check-Up" program, involving discussions, assessments, feedback, and skills training with a parent coach. | Behavioural | Parent-Child Dyads |
Primary outcome
Feasibility: Enrollment
Time frame: 2 weeks after final parent-child dyad completes the study
Proportion of parents agreeing to enroll in the intervention out of all parents approached
5 secondary outcomes
Feasibility: Number of sessions completed
Time frame: 2 weeks after final parent-child dyad completes the study
Interventionist fidelity
Time frame: 2 weeks after final parent-child dyad completes the study
Feasibility: usability of battery of measures
Time frame: 2 weeks after final parent-child dyad completes the study
Acceptability: parent satisfaction
Time frame: 10 weeks after parent baseline
Acceptability: interventionist satisfaction
Time frame: 2 weeks after final parent-child dyad completes the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
- 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.
Christina Studts, PhD principal investigator
University of Kentucky, Dept of Health, Behavior & Society
Matthew Bush, MD, PhD principal investigator
University of Kentucky, Dept of Otolaryngology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interventionist training and supervision and Behavioral parent training in people with Hearing Loss and Behavior Disorders, run by University of Kentucky 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 8 inclusion and 5 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: finished, as of the sponsor's last update on 17 Apr 2019. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Feasibility: Enrollment (time frame: 2 weeks after final parent-child dyad completes the study). 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 17 Apr 2019.