DepressionNCT00316290
Integrated Parent Training for Treating Depression in Mothers of Children With Attention Deficit Hyperactivity Disorder
A study testing Integrated Parent Training and Behavioral Parent Training in people with Depression and Attention Deficit Disorder With Hyperactivity, run by University of Maryland, College Park at 1 site in United States.
Trial summary
This study will determine the effectiveness of integrated parent training versus standard behavioral parent training in treating depression and stress in mothers of children with attention deficit hyperactivity disorder (ADHD). Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Depression, Attention Deficit Disorder With Hyperactivity
- What is being tested?
- Integrated Parent Training 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
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to Dec 2010
- 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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Mothers:
- Scores at least 10 on the Beck Depression Inventory (BDI)-II scale on two occasions approximately 1 week apart
- Does not meet criteria for current substance abuse, psychosis, or bipolar disorder, which would likely warrant other immediate treatment
- Children:
- Meets DSM-IV criteria for ADHD according to parent and teacher reports on rating scales and parent diagnostic interviews
- Estimated IQ of at least 70
- Aged between 6 and 12 years
- Lives with mother
Who cannot join
- Child has current Pervasive Development Disorder
- Mothers and children participating in psychosocial treatment that cannot be suspended
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland, College Park
College Park, Maryland, 20742
About this study
Official title: Integrated Treatment for Depressed Mothers of ADHD Children
This study will determine the effectiveness of integrated parent training versus standard behavioral parent training in treating depression and stress in mothers of children with attention deficit hyperactivity disorder (ADHD).
Read the detailed description
ADHD is one of the most common childhood mental disorders. Children with ADHD have impaired functioning in multiple settings, including home and school, and in relationships with peers. Parenting a child with ADHD can be discouraging and stressful. Research has shown that parent-child interactions are more negative among families with ADHD children. Additionally, families with children with ADHD experience increased parental stress, maternal depression, and marital distress, as compared to families with healthy children. These interactions may exacerbate the child's ADHD symptoms. Behavioral parent training has been used to improve parent-child relationships. This study will determine the effectiveness of integrated parent training versus standard behavioral parent training in treating depression and stress in mothers of children with ADHD.
Individuals interested in participating in this open-label study will first undergo an assessment of their eligibility for inclusion in the study. This session will last between 3 and 4 hours and will involve both the mother and the child. If eligible, mothers will be randomly assigned to receive either standard behavioral parent training or an integrated treatment, involving both behavioral parent training and cognitive-behavioral therapy targeted at coping with stressful parenting situations. The integrated treatment will also include a course on coping with depression. Both groups will meet for 2 hours every Wednesday evening for 14 weeks. Childcare will be provided, as well as free treatment for childrens' ADHD symptoms and mothers' depression. Both the child's and the mother's psychological functioning will be assessed upon study completion and at the 3-month follow-up visit.
- Being tested
- Integrated Parent Training, Behavioral Parent Training
- Keywords
- ADHD, Cognitive Behavioral Therapy, Parent Training
- Medical subject headings
- Depression, Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated Parent TrainingBehavioural
Treatment will include behavioral parent training, a course on coping with depression, and cognitive-behavioral therapy targeted at coping with stressful parenting situations. Treatment will include weekly 2-hour sessions for 14 weeks.
Behavioral Parent TrainingBehavioural
Parents will receive behavioral training. Treatment will include weekly 2-hour sessions for 14 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will receive integrated parent training. Receives: Behavioral: Integrated Parent Training |
| 2 | Active comparator | Parents will receive behavioral parent training. Receives: Behavioral: Behavioral Parent Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal depression
Measured: Measured post-treatment and at 3-month follow-up
Secondary outcomes (4)
Maternal stress and cognitions
Measured: Measured post-treatment and at 3-month follow-up
Child behavior and impairment
Measured: Measured post-treatment and at 3-month follow-up
Self-report and observed parenting behaviors
Measured: Measured post-treatment and at 3-month follow-up
Family functioning
Measured: Measured post-treatment and at 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2006 (estimated)
- Study startApr 2006
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, College Park
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Andrea Chronis-Tuscano, University of Maryland, College Park
- Investigators
- Andrea M. Chronis, PhD, Principal investigator, University of Maryland, College Park
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00316290
- Sponsor's protocol ID
- R34MH073567
- Other IDs
- R34MH073567, DSIR 84-CTS
- Status last verified
- May 2023
- First submitted
- 18 Apr 2006
- Last updated
- 11 May 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Treatment for Depressed Mothers of ADHD Children
- ClinicalTrials.gov ID
- NCT00316290
- Acronym / sponsor ID
- R34MH073567
- Keywords
- ADHD, Cognitive Behavioral Therapy, Parent Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- University of Maryland, College ParkUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Apr 2006
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 20 Apr 2006 (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 study will determine the effectiveness of integrated parent training versus standard behavioral parent training in treating depression and stress in mothers of children with attention deficit hyperactivity disorder (ADHD).
Detailed description
ADHD is one of the most common childhood mental disorders. Children with ADHD have impaired functioning in multiple settings, including home and school, and in relationships with peers. Parenting a child with ADHD can be discouraging and stressful. Research has shown that parent-child interactions are more negative among families with ADHD children. Additionally, families with children with ADHD experience increased parental stress, maternal depression, and marital distress, as compared to families with healthy children. These interactions may exacerbate the child's ADHD symptoms. Behavioral parent training has been used to improve parent-child relationships. This study will determine the effectiveness of integrated parent training versus standard behavioral parent training in treating depression and stress in mothers of children with ADHD.
Individuals interested in participating in this open-label study will first undergo an assessment of their eligibility for inclusion in the study. This session will last between 3 and 4 hours and will involve both the mother and the child. If eligible, mothers will be randomly assigned to receive either standard behavioral parent training or an integrated treatment, involving both behavioral parent training and cognitive-behavioral therapy targeted at coping with stressful parenting situations. The integrated treatment will also include a course on coping with depression. Both groups will meet for 2 hours every Wednesday evening for 14 weeks. Childcare will be provided, as well as free treatment for childrens' ADHD symptoms and mothers' depression. Both the child's and the mother's psychological functioning will be assessed upon study completion and at the 3-month follow-up visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Integrated Parent TrainingParticipants will receive integrated parent training. |
| 2 | Active comparator | Behavioral: Behavioral Parent TrainingParents will receive behavioral parent training. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Scores at least 10 on the Beck Depression Inventory (BDI)-II scale on two occasions approximately 1 week apart
- Does not meet criteria for current substance abuse, psychosis, or bipolar disorder, which would likely warrant other immediate treatment
- Meets DSM-IV criteria for ADHD according to parent and teacher reports on rating scales and parent diagnostic interviews
- Estimated IQ of at least 70
- Aged between 6 and 12 years
Key exclusion criteria (2 listed)
- Child has current Pervasive Development Disorder
- Mothers and children participating in psychosocial treatment that cannot be suspended
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 |
|---|---|---|
| Integrated Parent TrainingTreatment will include behavioral parent training, a course on coping with depression, and cognitive-behavioral therapy targeted at coping with stressful parenting situations. Treatment will include weekly 2-hour sessions for 14 weeks. | Behavioural | 1 |
| Behavioral Parent TrainingParents will receive behavioral training. Treatment will include weekly 2-hour sessions for 14 weeks. | Behavioural | 2 |
Primary outcome
Maternal depression
Time frame: Measured post-treatment and at 3-month follow-up
4 secondary outcomes
Maternal stress and cognitions
Time frame: Measured post-treatment and at 3-month follow-up
Child behavior and impairment
Time frame: Measured post-treatment and at 3-month follow-up
Self-report and observed parenting behaviors
Time frame: Measured post-treatment and at 3-month follow-up
Family functioning
Time frame: Measured post-treatment and at 3-month follow-up
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 11 May 2023.
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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.
Andrea M. Chronis, PhD principal investigator
University of Maryland, College Park
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated Parent Training and Behavioral Parent Training in people with Depression and Attention Deficit Disorder With Hyperactivity, run by University of Maryland, College Park 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 2 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 11 May 2023. 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?
Maternal depression (time frame: Measured post-treatment and at 3-month follow-up). 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 11 May 2023.