Family ConflictNCT03495440
Families of Youth with Developmental Disabilities: a Theory-Based Intervention
A study testing Center Sessions and At-home in people with Family Conflict and Marital Conflict, run by University of Notre Dame at 2 sites in United States.
Trial summary
This study is designed to evaluate a preventive intervention program designed to support families (parents and typically developing adolescent siblings) that include a child with an intellectual and/or developmental disability. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Family Conflict, Marital Conflict, Communication
- What is being tested?
- Center Sessions and At-home
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Aug 2017to 31 Dec 2024
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Participants in all conditions will include mothers, fathers, TD siblings between 11 and 17 years old, and individuals with IDD of any age.
- Participants must be able to understand and respond to survey questions in English
- Parents must be cohabitating, with both participating children living in their home.
- Individual with IDD falls into one or more of the following categories: 1) meets criteria for an intellectual disability, which would mean a measured IQ of 70-75 or lower and a measured Adaptive Functioning score of 70-75 or lower, 2) meets criteria for an Autism Spectrum Disorder based on an evaluation using the ADOS-2, SCQ, and expert clinical judgment based on DSM-5 ASD criteria, or 3) has a medically verified genetic condition (e.g., Down syndrome, Fragile X syndrome, Williams syndrome, Angelman syndrome, others) that is generally considered to be a developmental disability, and shows cognitive or adaptive functioning deficits (70-75 or below) although not necessarily deficits in both categories as would be needed for an Intellectual Disability diagnosis.
Who cannot join
- Siblings identified as typically developing will be excluded 1) with a score of 10 or higher on the SCQ-L, if a subsequent ADOS suggests that they have an ASD diagnosis, or 2) with a WASI-II score of 75 or lower.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet recruiting
Wm. J. Shaw Center for Children and Families
Fort Wayne, Indiana, 46814
Kathleen N Bergman, PhD, 574-631-0956, kbergman@nd.edu
- Recruiting
Wm. J. Shaw Center for Children and Families
South Bend, Indiana, 46814
Kathleen N Bergman, PhD, 574-631-0956, kbergman@nd.edu
E. M Cummings, PhD, 574-631-4947, ecumming@nd.edu
About this study
This study is designed to evaluate a preventive intervention program designed to support families (parents and typically developing adolescent siblings) that include a child with an intellectual and/or developmental disability. Participant families will be randomly assigned to either the treatment condition, in which they will receive psychoeducation and communication coaching over a four-week period, or the control condition, in which they will receive self-study materials. All subjects will participate in a pre-test assessment and three post-test assessments over the course of the year.
Read the detailed description
A critical need exists for an evidence-based program to ameliorate the impact of family stress and conflict on the overall well-being of parents and TD siblings, as well as individuals with IDD. Our objective in this study is to test the efficacy for parents, TD siblings, and children with IDD of an adaptation of the psycho-educational and communication training approach used in a previously validated prevention/intervention program for community families, and to examine the mechanisms associated with change processes that occur as a result of the 4-week program. Our long-term goal is to increase the availability and affordability of empirically-supported family-systems approaches to reduce family stress and conflict in families of individuals with IDD. Our central hypothesis is that participation in the program will support the identified needs of families with a child with IDD, improve the well-being and adjustment of parents, increase emotional security and adjustment for TD siblings, and be associated with improvements in adaptive functioning for individuals with IDD. This central hypothesis is supported by promising qualitative evidence and preliminary analyses from an ongoing pilot study using the adapted curriculum included in the present proposal. Our rationale is that providing a family-systems approach to improving the family environment will support the well-being of each family member, including the child with IDD. The specific aims are: (1) determining the efficacy of the program for parents, (2a) determining the efficacy of the program for typically developing siblings, (2b) testing process models, guided by the Emotional Security Theory (EST; Davies \& Cummings, 1994), to explain how and why and for whom and when changes occur as a result of the program, and (3) examining the impact of the program on individuals with IDD. Families (n=150) that include a child with IDD and a TD sibling between 11 and 17 years of age, will be randomly assigned to one of two groups: (1) parent and typically developing sibling intervention, or (2) resource only control. Multi-method assessments of all family members will be obtained at pre- and post-intervention visits, and 6-month and 1-year follow-ups. The approach is innovative because it addresses multiple family members' needs, tests theory about explanatory models for program impact, and utilizes a brief, psycho-educational format and a RCT design to evaluate its efficacy. This research is significant because it will create an inexpensive model program for family-system-level interventions for families of children with IDD, benefiting parents, siblings and the child with IDD, including evaluations of program effectiveness in standing community centers.
- Conditions
- Family Conflict, Marital Conflict, Communication
- Being tested
- Center Sessions, At-home
- Keywords
- Emotional Security, Intellectual Disability, Developmental Disability
- Medical subject headings
- Communication, Intellectual Disability, Developmental Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Center SessionsBehavioural
Program to support relationships and communication between parents and typically developing adolescent siblings of individuals with intellectual and/or developmental disabilities.
At-homeBehavioural
Self-study resources paired with regular contact with study personnel.
| Study group | Role | What they receive |
|---|---|---|
| Center Sessions | Experimental | Treatment condition in which participants receive psychoeducation and communication coaching. Receives: Behavioral: Center Sessions |
| At-home | Active comparator | Active, self-study control condition in which participants receive regular communication with study personnel and self-study materials to review on their own. Receives: Behavioral: At-home |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in marital satisfaction -- Short Marital Adjustment Scale (SMAT)
15-item parent self-report questionnaire measuring indices of marital satisfaction, including matters of disagreement, relationship dynamics, and happiness.
Measured: 1 year
Change in hostile interparental conflict -- O'Leary Porter Scales (OPS)
10-item parent self-report questionnaire designed to measure overt marital hostility exhibited in front of the children.
Measured: 1 year
Change in family functioning -- Family Environment Scale (FES)
27-item self-report measure that assesses dimensions of family functioning, specifically, the social domain of family relationships (cohesion, expressiveness, and conflict) to be completed by parents and typically developing siblings.
Measured: 1 year
Change in typically developing siblings' perception of interparental conflict -- Children's Perception of Inter-parental Conflict (CPIC)
19-item self-report questionnaire that captures three dimensions of marital conflict (frequency, intensity, and resolution) perceived by children.
Measured: 1 year
Change in typically developing siblings' levels of attachment to parents -- Inventory of Parent and Peer Attachment (IPPA)
25-item self-report questionnaire designed to assess adolescents' perceptions of the positive and negative affective dimension of relationships with their parents and peers. Typically developing siblings complete two forms (father and mother) on three scales: trust, communication, and alienation.
Measured: 1 year
Change in typically developing siblings' emotional security -- Security in the Subsystem (SIS) and Security in the Family System (SIFS)
The SIS is a child-report of the feelings and behaviors experienced when witnessing marital conflict. The SIFS is a self-report measure of adolescents' security in the family as a whole. Scores will be used in latent variables as a broad indicator of typically developing siblings' emotional security.
Measured: 1 year
Change in typically developing siblings' adjustment -- Strengths and Difficulties Questionnaire (SDQ)
25-item parent-report measure of prosocial behavior and psychopathology in their children.
Measured: 1 year
Change in typically developing siblings' behavior -- Youth Self-Report (YSR)
Adolescent self-report measure of perceived externalizing and internalizing behaviors.
Measured: 1 year
Change in typically developing siblings' depressive symptomatology -- Child Depression Inventory (CDI)
27-item self-report questionnaire measuring the extent of depression symptoms in children.
Measured: 1 year
Change on parents' depressive symptomatology - Beck Depression Inventory (BDI-II)
Parent self-report measure used to assess the severity of depression symptoms.
Measured: 1 year
Change in parents' problem drinking behaviors -- Parental Alcohol Experiences scale (PAE)
Parent self-report measure that provides a continuous measure of parental problem drinking.
Measured: 1 year
Change in the quality of family conflict interactions -- Family Interactions Coding System (FICS)
Video recorded quadratic (parent, TD sibling, child with IDD) interactions during which families discuss a topic of conflict are coded using an observational coding system to assess overall levels of constructiveness, destructiveness and resolution.
Measured: 1 year
Change in the quality of couples' conflict interactions -- Family Interactions Coding System (FICS)
Video recorded dyadic (interparental) interactions during which couples discuss a topic of conflict are coded using an observational coding system to assess overall levels of constructiveness, destructiveness and resolution.
Measured: 1 year
Change in family interactions in the home -- Daily Diaries
Parents complete 15 daily diaries following the 6-month and 12-month follow up assessments comprising of self-reports on the occurrence and quality of daily interparental and parent-child interactions.
Measured: 6 months
Secondary outcomes (1)
Change in adaptive functioning for individuals with IDD - Vineland Adaptive Behavior Scales II
Parent report measure describing skills and skill development in individuals with intellectual and/or developmental disabilities. Subscales focus on four domains: (1) Communication, (b) Daily Living Skills, (c) Socialization, and (d) Motor Skills. The domain composite scores make up the overall Adaptive Behavior Composite. The Internalizing and Externalizing subscales, and one subset of items labeled "Other" make up the optional Maladaptive Behavior Index. This index provides a measure of undesirable behaviors that may interfere with an individual's adaptive behavior.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2018
- Study start4 Aug 2017
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Family ConflictStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Notre Dame
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edward M Cummings, PhD, Principal investigator, University of Notre Dame
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03495440
- Sponsor's protocol ID
- 16-1246
- Status last verified
- Nov 2024
- First submitted
- 24 May 2017
- Last updated
- 15 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Families of Youth with Developmental Disabilities: a Theory-Based Intervention
- ClinicalTrials.gov ID
- NCT03495440
- Acronym / sponsor ID
- 16-1246
- Conditions
- Family Conflict, Marital Conflict, Communication
- Keywords
- Emotional Security, Intellectual Disability, Developmental Disability
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of Notre DameUniversity, hospital or other
- Study start
- 4 Aug 2017 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 12 Apr 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.
This study is designed to evaluate a preventive intervention program designed to support families (parents and typically developing adolescent siblings) that include a child with an intellectual and/or developmental disability. Participant families will be randomly assigned to either the treatment condition, in which they will receive psychoeducation and communication coaching over a four-week period, or the control condition, in which they will receive self-study materials. All subjects will participate in a pre-test assessment and three post-test assessments over the course of the year.
Detailed description
A critical need exists for an evidence-based program to ameliorate the impact of family stress and conflict on the overall well-being of parents and TD siblings, as well as individuals with IDD. Our objective in this study is to test the efficacy for parents, TD siblings, and children with IDD of an adaptation of the psycho-educational and communication training approach used in a previously validated prevention/intervention program for community families, and to examine the mechanisms associated with change processes that occur as a result of the 4-week program. Our long-term goal is to increase the availability and affordability of empirically-supported family-systems approaches to reduce family stress and conflict in families of individuals with IDD. Our central hypothesis is that participation in the program will support the identified needs of families with a child with IDD, improve the well-being and adjustment of parents, increase emotional security and adjustment for TD siblings, and be associated with improvements in adaptive functioning for individuals with IDD. This central hypothesis is supported by promising qualitative evidence and preliminary analyses from an ongoing pilot study using the adapted curriculum included in the present proposal. Our rationale is that providing a family-systems approach to improving the family environment will support the well-being of each family member, including the child with IDD. The specific aims are: (1) determining the efficacy of the program for parents, (2a) determining the efficacy of the program for typically developing siblings, (2b) testing process models, guided by the Emotional Security Theory (EST; Davies \& Cummings, 1994), to explain how and why and for whom and when changes occur as a result of the program, and (3) examining the impact of the program on individuals with IDD. Families (n=150) that include a child with IDD and a TD sibling between 11 and 17 years of age, will be randomly assigned to one of two groups: (1) parent and typically developing sibling intervention, or (2) resource only control. Multi-method assessments of all family members will be obtained at pre- and post-intervention visits, and 6-month and 1-year follow-ups. The approach is innovative because it addresses multiple family members' needs, tests theory about explanatory models for program impact, and utilizes a brief, psycho-educational format and a RCT design to evaluate its efficacy. This research is significant because it will create an inexpensive model program for family-system-level interventions for families of children with IDD, benefiting parents, siblings and the child with IDD, including evaluations of program effectiveness in standing community centers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Center Sessions | Experimental | Behavioral: Center SessionsTreatment condition in which participants receive psychoeducation and communication coaching. |
| At-home | Active comparator | Behavioral: At-homeActive, self-study control condition in which participants receive regular communication with study personnel and self-study materials to review on their own. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Participants in all conditions will include mothers, fathers, TD siblings between 11 and 17 years old, and individuals with IDD of any age.
- Participants must be able to understand and respond to survey questions in English
- Parents must be cohabitating, with both participating children living in their home.
- Individual with IDD falls into one or more of the following categories: 1) meets criteria for an intellectual disability, which would mean a measured IQ of 70-75 or lower and a measured Adaptive Functioning score of 70-75 or lower, 2) meets criteria for an Autism Spectrum Disorder based on an evaluation using the ADOS-2, SCQ, and expert clinical judgment based on DSM-5 ASD criteria, or 3) has a medically verified genetic condition (e.g., Down syndrome, Fragile X syndrome, Williams syndrome, Angelman syndrome, others) that is generally considered to be a developmental disability, and shows cognitive or adaptive functioning deficits (70-75 or below) although not necessarily deficits in both categories as would be needed for an Intellectual Disability diagnosis.
Key exclusion criteria (1 listed)
- Siblings identified as typically developing will be excluded 1) with a score of 10 or higher on the SCQ-L, if a subsequent ADOS suggests that they have an ASD diagnosis, or 2) with a WASI-II score of 75 or lower.
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 |
|---|---|---|
| Center SessionsProgram to support relationships and communication between parents and typically developing adolescent siblings of individuals with intellectual and/or developmental disabilities. | Behavioural | Center Sessions |
| At-homeSelf-study resources paired with regular contact with study personnel. | Behavioural | At-home |
Primary outcome
Change in marital satisfaction -- Short Marital Adjustment Scale (SMAT)
Time frame: 1 year
15-item parent self-report questionnaire measuring indices of marital satisfaction, including matters of disagreement, relationship dynamics, and happiness.
Change in hostile interparental conflict -- O'Leary Porter Scales (OPS)
Time frame: 1 year
10-item parent self-report questionnaire designed to measure overt marital hostility exhibited in front of the children.
Change in family functioning -- Family Environment Scale (FES)
Time frame: 1 year
27-item self-report measure that assesses dimensions of family functioning, specifically, the social domain of family relationships (cohesion, expressiveness, and conflict) to be completed by parents and typically developing siblings.
Change in typically developing siblings' perception of interparental conflict -- Children's Perception of Inter-parental Conflict (CPIC)
Time frame: 1 year
19-item self-report questionnaire that captures three dimensions of marital conflict (frequency, intensity, and resolution) perceived by children.
Change in typically developing siblings' levels of attachment to parents -- Inventory of Parent and Peer Attachment (IPPA)
Time frame: 1 year
25-item self-report questionnaire designed to assess adolescents' perceptions of the positive and negative affective dimension of relationships with their parents and peers. Typically developing siblings complete two forms (father and mother) on three scales: trust, communication, and alienation.
Change in typically developing siblings' emotional security -- Security in the Subsystem (SIS) and Security in the Family System (SIFS)
Time frame: 1 year
The SIS is a child-report of the feelings and behaviors experienced when witnessing marital conflict. The SIFS is a self-report measure of adolescents' security in the family as a whole. Scores will be used in latent variables as a broad indicator of typically developing siblings' emotional security.
Change in typically developing siblings' adjustment -- Strengths and Difficulties Questionnaire (SDQ)
Time frame: 1 year
25-item parent-report measure of prosocial behavior and psychopathology in their children.
Change in typically developing siblings' behavior -- Youth Self-Report (YSR)
Time frame: 1 year
Adolescent self-report measure of perceived externalizing and internalizing behaviors.
Change in typically developing siblings' depressive symptomatology -- Child Depression Inventory (CDI)
Time frame: 1 year
27-item self-report questionnaire measuring the extent of depression symptoms in children.
Change on parents' depressive symptomatology - Beck Depression Inventory (BDI-II)
Time frame: 1 year
Parent self-report measure used to assess the severity of depression symptoms.
Change in parents' problem drinking behaviors -- Parental Alcohol Experiences scale (PAE)
Time frame: 1 year
Parent self-report measure that provides a continuous measure of parental problem drinking.
Change in the quality of family conflict interactions -- Family Interactions Coding System (FICS)
Time frame: 1 year
Video recorded quadratic (parent, TD sibling, child with IDD) interactions during which families discuss a topic of conflict are coded using an observational coding system to assess overall levels of constructiveness, destructiveness and resolution.
Change in the quality of couples' conflict interactions -- Family Interactions Coding System (FICS)
Time frame: 1 year
Video recorded dyadic (interparental) interactions during which couples discuss a topic of conflict are coded using an observational coding system to assess overall levels of constructiveness, destructiveness and resolution.
Change in family interactions in the home -- Daily Diaries
Time frame: 6 months
Parents complete 15 daily diaries following the 6-month and 12-month follow up assessments comprising of self-reports on the occurrence and quality of daily interparental and parent-child interactions.
1 secondary outcome
Change in adaptive functioning for individuals with IDD - Vineland Adaptive Behavior Scales II
Time frame: 1 year
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 15 Nov 2024.
- 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.
Edward M Cummings, PhD principal investigator
University of Notre Dame
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Center Sessions and At-home in people with Family Conflict and Marital Conflict, run by University of Notre Dame at 2 sites 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 4 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: looking for participants now, as of the sponsor's last update on 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Contact Edward M Cummings, PhD (574-631-4947, ecumming@nd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in marital satisfaction -- Short Marital Adjustment Scale (SMAT) (time frame: 1 year). The study lists 14 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 15 Nov 2024.