Parent-Child RelationsNCT06309329
Strength at Home - Parents RCT
A study testing Strength at Home Parents and VA treatment as usual in people with Parent-Child Relations, run by VISN 17 Center of Excellence at 1 site in United States.
Trial summary
The goal of this clinical trial is to compare the effect of the Strength at Home Parents intervention to treatment as usual in veterans enrolled for care at VA facilities in VISN 17 on parenting stress and parenting behaviors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parent-Child Relations
- What is being tested?
- Strength at Home Parents and VA treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2024to May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible participants are veterans enrolled in any VA VISN 17 facility who meet the following inclusion criteria: Current parent to a child between the ages of 3 and 12 (the index child), who resides with the participant or spends at least two days per week with the participant, elevated PTSD symptoms and Parent-child functioning problems.
Who cannot join
- Major neurocognitive disorder likely to impact comprehension of material, including severe TBI .
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Central Texas Veterans Healthcare System
Temple, Texas, 76504
About this study
Official title: Randomized Clinical Trial of Parent Training for Veterans With PTSD Symptoms (Strength at Home - Parents RCT)
The goal of this clinical trial is to compare the effect of the Strength at Home Parents intervention to treatment as usual in veterans enrolled for care at VA facilities in VISN 17 on parenting stress and parenting behaviors. The participant population will have elevated PTSD symptoms and parent-child functioning difficulties with an index child between the ages of 3-12. The main question[s]it aims to answer are: • Does Strength at Home Parents improve parenting stress and parenting behaviors in comparison to a no-treatment control condition? • Are gains maintained over time and is there a gender difference in efficacy? Participants will complete 4 online assessments, and if randomized to the intervention group they will complete an 8 week tele-health group program. If randomized to the control group participants will receive a link to the VA parenting resources website and any referrals they would like to have. Researchers will compare Strength at Home Parents to VA treatment as usual see if the group intervention improves parenting stress and behaviors above and beyond the existing resources.
- Conditions
- Parent-Child Relations
- Being tested
- Strength at Home Parents, VA treatment as usual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength at Home ParentsBehavioural
Strength at Home parents is an 8 week trauma-informed and cognitive behavioral tele-health group intervention that aims to improve parenting behaviors and overall parent-child and family functioning among U.S. military Veterans with post-traumatic stress disorder symptoms
VA treatment as usualBehavioural
VA treatment as usual includes referral to the online resources at veterantraining.va.gov/parenting .
| Study group | Role | What they receive |
|---|---|---|
| Strength at Home Parents | Experimental | Not described Receives: Behavioral: Strength at Home Parents |
| VA treatment as usual | Active comparator | Not described Receives: Behavioral: VA treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parenting Stress Index total score
The Parenting Stress Index, 4th edition (PSI) has 120 items scored on a 5-point scale, yielding a parent and child domain scale measuring stress related to parent and child characteristics. These scale scores are combined to yield a total stress score.
Measured: Time 2: 8-16 weeks
Parenting Stress Index total score
The Parenting Stress Index, 4th edition (PSI) has 120 items scored on a 5-point scale, yielding a parent and child domain scale measuring stress related to parent and child characteristics. These scale scores are combined to yield a total stress score.
Measured: Time 3: 16-24 weeks
Parenting Stress Index total score
The Parenting Stress Index, 4th edition (PSI) has 120 items scored on a 5-point scale, yielding a parent and child domain scale measuring stress related to parent and child characteristics. These scale scores are combined to yield a total stress score.
Measured: Time 4: 24-32 weeks
Secondary outcomes (6)
Laxness subscale on the Parenting Scale
The laxness scale is comprised of 11 items measuring permissive, inconsistent discipline
Measured: Time 2: 8-16 weeks
Laxness subscale on the Parenting Scale
The laxness scale is comprised of 11 items measuring permissive, inconsistent discipline
Measured: Time 3: 16-24 weeks
Laxness subscale on the Parenting Scale
The laxness scale is comprised of 11 items measuring permissive, inconsistent discipline
Measured: Time 4: 24-32 weeks
Over reactivity subscale on the Parenting scale
The over reactivity scale (10 items) measures use of emotional, harsh discipline
Measured: Time 2: 8-16 weeks
Over reactivity subscale on the Parenting scale
The over reactivity scale (10 items) measures use of emotional, harsh discipline
Measured: Time 3: 16-24 weeks
Over reactivity subscale on the Parenting scale
The over reactivity scale (10 items) measures use of emotional, harsh discipline
Measured: Time 4: 24-32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start30 Mar 2024
- Primary completionMay 2029 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parent-Child RelationsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VISN 17 Center of Excellence
- Sponsor type
- US federal agency
- Collaborators
- United States Department of Defense, University of Texas at Austin
- Responsible party
- Principal investigator, Suzannah Creech, VISN 17 Center of Excellence
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06309329
- Sponsor's protocol ID
- 1770023-2
- Status last verified
- Apr 2024
- First submitted
- 6 Mar 2024
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A de-identified copy of study data will be shared on a yearly basis to the National Institute of Mental Health Data Archive registry (e.g., National Institute of Mental Health (NIMH) data archive (NDA)).
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of Parent Training for Veterans With PTSD Symptoms (Strength at Home - Parents RCT)
- ClinicalTrials.gov ID
- NCT06309329
- Acronym / sponsor ID
- 1770023-2
- Conditions
- Parent-Child Relations
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- VISN 17 Center of ExcellenceUS federal agency
- Collaborators
- United States Department of Defense, University of Texas at Austin
- Study start
- 30 Mar 2024 (actual)
- Primary completion
- May 2029 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 13 Mar 2024 (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.
The goal of this clinical trial is to compare the effect of the Strength at Home Parents intervention to treatment as usual in veterans enrolled for care at VA facilities in VISN 17 on parenting stress and parenting behaviors. The participant population will have elevated PTSD symptoms and parent-child functioning difficulties with an index child between the ages of 3-12. The main question[s]it aims to answer are: • Does Strength at Home Parents improve parenting stress and parenting behaviors in comparison to a no-treatment control condition? • Are gains maintained over time and is there a gender difference in efficacy? Participants will complete 4 online assessments, and if randomized to the intervention group they will complete an 8 week tele-health group program. If randomized to the control group participants will receive a link to the VA parenting resources website and any referrals they would like to have. Researchers will compare Strength at Home Parents to VA treatment as usual see if the group intervention improves parenting stress and behaviors above and beyond the existing resources.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Strength at Home Parents | Experimental | Behavioral: Strength at Home Parents |
| VA treatment as usual | Active comparator | Behavioral: VA treatment as usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Eligible participants are veterans enrolled in any VA VISN 17 facility who meet the following inclusion criteria: Current parent to a child between the ages of 3 and 12 (the index child), who resides with the participant or spends at least two days per week with the participant, elevated PTSD symptoms and Parent-child functioning problems.
Key exclusion criteria (1 listed)
- Major neurocognitive disorder likely to impact comprehension of material, including severe TBI .
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 |
|---|---|---|
| Strength at Home ParentsStrength at Home parents is an 8 week trauma-informed and cognitive behavioral tele-health group intervention that aims to improve parenting behaviors and overall parent-child and family functioning among U.S. military Veterans with post-traumatic stress disorder symptoms | Behavioural | Strength at Home Parents |
| VA treatment as usualVA treatment as usual includes referral to the online resources at veterantraining.va.gov/parenting . | Behavioural | VA treatment as usual |
Primary outcome
Parenting Stress Index total score
Time frame: Time 2: 8-16 weeks
The Parenting Stress Index, 4th edition (PSI) has 120 items scored on a 5-point scale, yielding a parent and child domain scale measuring stress related to parent and child characteristics. These scale scores are combined to yield a total stress score.
Parenting Stress Index total score
Time frame: Time 3: 16-24 weeks
The Parenting Stress Index, 4th edition (PSI) has 120 items scored on a 5-point scale, yielding a parent and child domain scale measuring stress related to parent and child characteristics. These scale scores are combined to yield a total stress score.
Parenting Stress Index total score
Time frame: Time 4: 24-32 weeks
The Parenting Stress Index, 4th edition (PSI) has 120 items scored on a 5-point scale, yielding a parent and child domain scale measuring stress related to parent and child characteristics. These scale scores are combined to yield a total stress score.
6 secondary outcomes
Laxness subscale on the Parenting Scale
Time frame: Time 2: 8-16 weeks
Laxness subscale on the Parenting Scale
Time frame: Time 3: 16-24 weeks
Laxness subscale on the Parenting Scale
Time frame: Time 4: 24-32 weeks
Over reactivity subscale on the Parenting scale
Time frame: Time 2: 8-16 weeks
Over reactivity subscale on the Parenting scale
Time frame: Time 3: 16-24 weeks
Over reactivity subscale on the Parenting scale
Time frame: Time 4: 24-32 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- Individual participant dataSharing planned: Yes. A de-identified copy of study data will be shared on a yearly basis to the National Institute of Mental Health Data Archive registry (e.g., National Institute of Mental Health (NIMH) data archive (NDA)).
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strength at Home Parents and VA treatment as usual in people with Parent-Child Relations, run by VISN 17 Center of Excellence 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 1 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: enrolling by invitation, as of the sponsor's last update on 24 Apr 2024. 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?
This study is still under way. Results are not available in the source record yet.
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?
Parenting Stress Index total score (time frame: Time 2: 8-16 weeks). The study lists 3 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 24 Apr 2024.