Child MaltreatmentPhase 1/2NCT01294475
Preventing Child Maltreatment Through A Cellular-Phone Technology-Based Parenting Program
A Phase 1/2 study testing Planned Activities Training in people with Child Maltreatment, run by Centers for Disease Control and Prevention at 1 site in United States.
Trial summary
The goal of this project is to examine the effects of the use of cellular-phone technology in conjunction with a parenting program entitled "Planned Activities Training (PAT)" on participant enrollment, engagement, and motivation for the PAT intervention, as well as on parent and child outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Child Maltreatment
- What is being tested?
- Planned Activities Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 371 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Aug 2011
- Phase
- Phase 1/2
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women between the ages of 15-18 at the time of their first child's birth OR between the ages of 22-35 years at the time of their first child's birth, with no formal education beyond high school or GED
- Mothers' oldest biological child should be between 4 and 6 years
- Families anticipate living in the 50 mile vicinity of Kansas City or South Bend for the next 18 months
- Primary caregiver should be functionally literate.
- Must speak English or Spanish fluently.
Who cannot join
- Mother has a major medical illness that could interfere with her ability to participate in a 2-year project
- Mother currently lives in a treatment program or rehab center
- Mother has a serious mental illness
- Mother lives in a group home or correctional program.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this project is to examine the effects of the use of cellular-phone technology in conjunction with a parenting program entitled "Planned Activities Training (PAT)" on participant enrollment, engagement, and motivation for the PAT intervention, as well as on parent and child outcomes.
Read the detailed description
The current project will employ a 3-group experimental design with random assignment of parents to one of three groups: Planned Activities Training as usual (PAT); Cellular Phone Enhanced PAT (CPAT), or a no-intervention control group. Two cohorts of high-risk mother-child dyads (low education or mother adolescent at time of birth) will be recruited. In years 1 and 2, the first cohort of participants will be recruited in Kansas City, MO and South Bend, IN from an ongoing longitudinal descriptive study of child neglect, which has tracked risk and protective factors since the child's birth (n=180). During years 3 and 4, a second cohort of matched high risk mothers (operationally defined the same as for cohort 1) will be recruited from Head Start programs within the same two communities (n=180). Families in both cohorts will be enrolled when the first family child is between the ages of 4 and 6 years.
Participants assigned to the intervention groups will receive intervention services in the home setting and will be assessed prior to the intervention, as well as at 1-, 6-, and 12- month post-intervention time points. The control group participants will complete assessments at similar time points to the intervention groups. Several outcomes will be examined in order to measure intervention effects, including child maltreatment risk and occurrences, parent behaviors, and child behaviors. These outcomes will be collected utilizing a multi-method approach that will involve parent interview, parent-report and self-report measures, mother-child observation, and review of local CPS system records. For those parents participating in an intervention group, data will also be collected on maternal engagement, retention, fidelity, and dosage with regard to the intervention. Lastly, program and participant costs will be examined to determine the cost-effectiveness of including a technological component with this existing parenting program. It is expected that the knowledge generated through this study will aid in the improvement of parenting interventions targeting the prevention of child maltreatment.
- Conditions
- Child Maltreatment
- Being tested
- Planned Activities Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Planned Activities TrainingBehavioural
Mothers will be provided a parenting intervention, Planned Activities Training (PAT). Some of the mothers will receive the PAT intervention enhanced with a cell phone.
| Study group | Role | What they receive |
|---|---|---|
| Cell Phone Enhanced Parent Training | Experimental | Cell phones will be provided to mothers participating in Planned Activities Training. Receives: Behavioral: Planned Activities Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Maltreatment
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2011 (estimated)
- Study startMay 2007
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Child MaltreatmentStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 371 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Judy Carta, Ph.D., Principal investigator, University of Kansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01294475
- Sponsor's protocol ID
- CDC-NCIPC-5054
- Status last verified
- May 2013
- First submitted
- 10 Feb 2011
- Last updated
- 9 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Carta JJ, Lefever JB, Bigelow K, Borkowski J, Warren SF. Randomized trial of a cellular phone-enhanced home visitation parenting intervention. Pediatrics. 2013 Nov;132 Suppl 2(Suppl 2):S167-73. doi: 10.1542/peds.2013-1021Q.
PubMed 24187120
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Child Maltreatment Through A Cellular-Phone Technology-Based Parenting Program
- ClinicalTrials.gov ID
- NCT01294475
- Acronym / sponsor ID
- CDC-NCIPC-5054
- Conditions
- Child Maltreatment
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 371 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Study start
- May 2007
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 11 Feb 2011 (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.
The goal of this project is to examine the effects of the use of cellular-phone technology in conjunction with a parenting program entitled "Planned Activities Training (PAT)" on participant enrollment, engagement, and motivation for the PAT intervention, as well as on parent and child outcomes.
Detailed description
The current project will employ a 3-group experimental design with random assignment of parents to one of three groups: Planned Activities Training as usual (PAT); Cellular Phone Enhanced PAT (CPAT), or a no-intervention control group. Two cohorts of high-risk mother-child dyads (low education or mother adolescent at time of birth) will be recruited. In years 1 and 2, the first cohort of participants will be recruited in Kansas City, MO and South Bend, IN from an ongoing longitudinal descriptive study of child neglect, which has tracked risk and protective factors since the child's birth (n=180). During years 3 and 4, a second cohort of matched high risk mothers (operationally defined the same as for cohort 1) will be recruited from Head Start programs within the same two communities (n=180). Families in both cohorts will be enrolled when the first family child is between the ages of 4 and 6 years.
Participants assigned to the intervention groups will receive intervention services in the home setting and will be assessed prior to the intervention, as well as at 1-, 6-, and 12- month post-intervention time points. The control group participants will complete assessments at similar time points to the intervention groups. Several outcomes will be examined in order to measure intervention effects, including child maltreatment risk and occurrences, parent behaviors, and child behaviors. These outcomes will be collected utilizing a multi-method approach that will involve parent interview, parent-report and self-report measures, mother-child observation, and review of local CPS system records. For those parents participating in an intervention group, data will also be collected on maternal engagement, retention, fidelity, and dosage with regard to the intervention. Lastly, program and participant costs will be examined to determine the cost-effectiveness of including a technological component with this existing parenting program. It is expected that the knowledge generated through this study will aid in the improvement of parenting interventions targeting the prevention of child maltreatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cell Phone Enhanced Parent Training | Experimental | Behavioral: Planned Activities TrainingCell phones will be provided to mothers participating in Planned Activities Training. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women between the ages of 15-18 at the time of their first child's birth OR between the ages of 22-35 years at the time of their first child's birth, with no formal education beyond high school or GED
- Mothers' oldest biological child should be between 4 and 6 years
- Families anticipate living in the 50 mile vicinity of Kansas City or South Bend for the next 18 months
- Primary caregiver should be functionally literate.
- Must speak English or Spanish fluently.
Key exclusion criteria (4 listed)
- Mother has a major medical illness that could interfere with her ability to participate in a 2-year project
- Mother currently lives in a treatment program or rehab center
- Mother has a serious mental illness
- Mother lives in a group home or correctional program.
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 |
|---|---|---|
| Planned Activities TrainingMothers will be provided a parenting intervention, Planned Activities Training (PAT). Some of the mothers will receive the PAT intervention enhanced with a cell phone. | Behavioural | Cell Phone Enhanced Parent Training |
Primary outcome
Child Maltreatment
Time frame: 12 months
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 9 May 2013.
- Derived from this study: PubMed 24187120Carta JJ, Lefever JB, Bigelow K, Borkowski J, Warren SF. Randomized trial of a cellular phone-enhanced home visitation parenting intervention. Pediatrics. 2013 Nov;132 Suppl 2(Suppl 2):S167-73. doi: 10.1542/peds.2013-1021Q.
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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.
Judy Carta, Ph.D. principal investigator
University of Kansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Planned Activities Training in people with Child Maltreatment, run by Centers for Disease Control and Prevention 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 5 inclusion and 4 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 9 May 2013. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Child Maltreatment (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01294475, which also lists 1 linked publication.
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 9 May 2013; AzTrials last refreshed its copy on 29 Oct 2026.